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MerlinTrader Biotech Calendar

Biotech Catalyst Calendar 2026: FDA and PDUFA Calendar

FDA decisions, PDUFA dates, advisory committees and clinical-trial readouts for publicly traded biotech stocks.

Tables updated: October 4, 2026; glossary reviewed: September 19, 2026

This is Merlintrader’s dedicated biotech catalyst calendar. It tracks upcoming FDA decisions, PDUFA target dates, advisory committee meetings, NDA and BLA milestones, regulatory submissions and major clinical-trial readouts for publicly traded biotech and healthcare companies, including selected non-U.S. listings with FDA milestones.

Each entry is designed to show the expected timing, event type, company context and available source trail. The tables separate confirmed dates, conference ranges, estimated company windows and recent history. Each entry links to its sources; the embedded calendar provides a wider archive.

Catalyst dates can change, FDA decisions can arrive early or late and clinical readouts can be postponed. Always confirm each event against company filings, official press releases and regulatory sources before making any trading or investment decision.

Calendar: upcoming catalysts and history

These tables are an editorial selection of events supported by primary sources. Regulatory dates, confirmed presentations and company windows are separated; passed or completed events appear only in history, with their verified status stated. A PDUFA date is a review goal, not a promise of approval.

Updated October 4, 2026 — 546 upcoming events or open windows — 35 recent historical events. Current company guidance, primary sources and congress links; precise dates and estimates are distinguished.

Confirmed regulatory deadlines: 58 events

Date / windowTickerCompanyEventStatusSources
2026-10-09$RHHBYRocheTecentriq (atezolizumab) and Tecentriq Hybreza in combination with chemotherapy, adjuvant use — stage III colon cancer with deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) status Priority review granted on data from the phase III ATOMIC study in 712 patients; Roche states the FDA is expected to decide by 9 October 2026. Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-10-15$RHHBYRocheEnspryng (satralizumab) — moderate-to-severe thyroid eye disease Priority Review based on SatraGO-1 and SatraGO-2. SatraGO-2 met its primary endpoint; SatraGO-1 did not reach statistical significance. Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-10-17$IRDOpus Genetics, Inc.MR-141, phentolamine ophthalmic solution 0.75% — presbyopia One sNDA shared by both partners, counted once. Sources: ; | Checked: 2026-09-19Confirmed datePrimary source
Supporting source
2026-10-17$VTRSViatris Inc.MR-141, phentolamine ophthalmic solution 0.75% — presbyopia One sNDA shared by both partners, counted once. Sources: ; | Checked: 2026-09-19Confirmed datePrimary source
Supporting source
2026-10-26$IONSIONIS PHARMACEUTICALS INCBepirovirsen, developed with GSK, for chronic hepatitis B. FDA goal October 26, 2026; one shared regulatory event already represented under IONS, not a new independent GSK deadline.Confirmed datePrimary source
Supporting source
2026-10-30$INOInovio Pharmaceuticals, Inc.INO-3107, DNA immunotherapy — recurrent respiratory papillomatosis in adults Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-01$AGIOAgios Pharmaceuticals, Inc.Pyrukynd (mitapivat) — sickle cell disease, accelerated approval pathway Sources: | Checked: 2026-09-19 | Program detail: PYRUKYND (mitapivat); NDA.Confirmed datePrimary source
2026-11-14$BTAIBioXcel Therapeutics, Inc.Igalmi (dexmedetomidine, sublingual film) — acute agitation in bipolar disorder or schizophrenia, at-home use Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-14$CYTKCYTOKINETICS INCaficamten — obstructive hypertrophic cardiomyopathy, extension based on the MAPLE-HCM trial Sources: | Checked: 2026-09-19 | Program detail: MYQORZO (aficamten).Confirmed datePrimary source
2026-11-14$SMMTSummit Therapeutics Inc.ivonescimab (SMT112) — EGFR-mutated non-squamous NSCLC, after TKI, in combination with chemotherapy Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-22$CAPRCAPRICOR THERAPEUTICS, INC.deramiocel (CAP-1002), cell therapy — Duchenne muscular dystrophy; refined proposed indication focused on upper limb function. FDA review of the BLA major amendment includes 24-month HOPE-3 open-label extension data and robustness analyses. On 24 August 2026 Capricor announced a three-month extension from 22 August to 22 November 2026. The target date is not an approval.Confirmed datePrimary source
2026-11-22$SVRASavara Inc.Molbreevi (molgramostim), inhalation solution — autoimmune pulmonary alveolar proteinosis date extended by three months for a major amendment Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-25$SNYSanofivenglustat, oral glucosylceramide synthase inhibitor — Gaucher disease type 3, neurological manifestations Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-27$BBIOBridgeBio Pharma, Inc.BBP-418 — limb-girdle muscular dystrophy LGMD2I/R9 Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-27$GSKGSKneladalkib (NVL-655) — advanced ALK-positive NSCLC, previously treated with TKI formerly a Nuvalent asset, acquired by GSK on 15 July 2026 Sources: ; | Checked: 2026-09-19Confirmed datePrimary source
Supporting source
2026-11-27$RPRXRoyalty Pharma plcneladalkib — ALK-positive non-small cell lung cancer; royalty interest. FDA target action date: 2026-11-27.Confirmed datePrimary source
2026-11-28$PYPDPolyPid Ltd.D-PLEX100, local prolonged-release doxycycline depot — prevention of surgical site infections in colorectal surgery Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-30$COGTCogent Biosciences, Inc.bezuclastinib, with sunitinib — gastrointestinal stromal tumours previously treated with imatinib Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-30$RHHBYF. Hoffmann-La Roche Ltdgiredestrant — adjuvant treatment of ER-positive, HER2-negative early breast cancer, lidERA trial Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-30$VRTXVERTEX PHARMACEUTICALS INCORPORATEDpovetacicept, dual BAFF and APRIL inhibitor — IgA nephropathy, accelerated approval pathway Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-11-30$ZLABZai Lab Limitedpovetacicept — IgA nephropathy; Vertex partner. FDA target action date: 2026-11-30.Confirmed datePrimary source
2026-12-12$ANABANAPTYSBIO, INCimsidolimab — generalized pustular psoriasis; Vanda partner. FDA target action date: 2026-12-12.Confirmed datePrimary source
2026-12-12$VNDAVanda Pharmaceuticals Inc.imsidolimab, IL-36R antagonist — generalized pustular psoriasis molecule originated by AnaptysBio, BLA held by Vanda Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-12-17$CORTCorcept Therapeutics Incorporatedrelacorilant, selective glucocorticoid receptor antagonist — Cushing's syndrome NDA resubmitted on 17 June 2026 after a CRL on this indication Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-12-18$CAMXCamurus ABCAM2029 (Oclaiz), acromegaly NDA resubmission: FDA target action date. CONFIRMED 2026-12-18. A review target is not an approval. Nasdaq Stockholm ticker CAMX.Confirmed datePrimary source
2026-12-18$RHHBYF. Hoffmann-La Roche Ltdgiredestrant + everolimus — ER+/HER2− advanced or metastatic breast cancer with an ESR1 mutation, following progression on or after prior endocrine therapy Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-12-22$MLYSMineralys Therapeutics, Inc.lorundrostat — hypertension in adults, in combination with other antihypertensives Sources: | Checked: 2026-09-19 | Program detail: lorundrostat; NDA.Confirmed datePrimary source
2026-12-23$GILDGILEAD SCIENCES, INC.anito-cel (anitocabtagene autoleucel), anti-BCMA CAR-T — relapsed or refractory multiple myeloma, fourth line BLA filed by Arcellx, acquired by Gilead on 28 April 2026 Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-12-27$PRAXPraxis Precision Medicines, Inc.relutrigine — SCN2A and SCN8A developmental and epileptic encephalopathies date extended from 27 September 2026 for a major amendment Sources: | Checked: 2026-09-19 | Program detail: relutrigine; NDA.Confirmed datePrimary source
2026-12-27$VTRSViatris Inc.fast-acting meloxicam — moderate to severe acute pain, non-opioid analgesic Sources: | Checked: 2026-09-19Confirmed datePrimary source
2026-12-30$COGTCogent Biosciences, Inc.bezuclastinib monotherapy — non-advanced systemic mastocytosis Sources: | Checked: 2026-09-19Confirmed datePrimary source
4 January 2027$NUVBNUVATION BIO INCPDUFA: IBTROZI (taletrectinib) · NSCLC advanced ROS1+ non-small cell lung cancer. Company timing: 4 January 2027. FDA target action date; approval is not assured. Primary source dated 2026-08-06; checked 2026-10-04.Confirmed datePrimary source
2027-01-06$IBRXIMMUNITYBIO, INC.ANKTIVA with BCG — BCG-unresponsive papillary-only non-muscle invasive bladder cancer. FDA target action date: 2027-01-06.Confirmed datePrimary source
2027-01-21$DYNDyne Therapeutics, Inc.z-rostudirsen (DYNE-251) — Duchenne muscular dystrophy amenable to exon 51 skipping. FDA target action date: 2027-01-21.Confirmed datePrimary source
2027-01-29$PRAXPraxis Precision Medicines, Inc.ulixacaltamide — essential tremor. FDA target action date: 2027-01-29.Confirmed datePrimary source
2027-02-12$BLTEBELITE BIO, INCtinlarebant — Stargardt disease type 1. FDA target action date: 2027-02-12.Confirmed datePrimary source
2027-02-23$ARQTArcutis Biotherapeutics, Inc.Zoryve cream 0.05% — atopic dermatitis, infants aged 3 to 24 months. FDA target action date: 2027-02-23.Confirmed datePrimary source
2027-02-27$CGEMCullinan Therapeutics, Inc.zipalertinib — EGFR exon 20 insertion non-small cell lung cancer. FDA target action date: 2027-02-27.Confirmed datePrimary source
2027-02-28$APMDApnimed, Inc.AD109 — obstructive sleep apnea. FDA target action date: 2027-02-28.Confirmed datePrimary source
2027-02-28$BMRNBioMarin Pharmaceutical Inc.Voxzogo (vosoritide) — full approval in children with achondroplasia. FDA target action date: 2027-02-28.Confirmed datePrimary source
2027-02-28$SRPTSarepta Therapeutics, Inc.AMONDYS 45 and VYONDYS 53 — Duchenne muscular dystrophy; traditional approval conversion. FDA target action date: 2027-02-28.Confirmed datePrimary source
2027-03-03$EXELEXELIXIS, INC.zanzalintinib + atezolizumab — previously treated metastatic colorectal cancer, STELLAR-303 New target March 3, 2027; December 3, 2026 is no longer an active deadline. FDA notified the company on September 10 that new safety and efficacy data constituted a major amendment; filing dated September 11. Sources: | Checked: 2026-09-19Confirmed datePrimary source
10 March 2027$NTLAINTELLIA THERAPEUTICS INCPDUFA: lonvoguran ziclumeran (also referred to as NTLA-2002) · HAE Hereditary Angioedema (HAE) (NDA). Company timing: 10 March 2027. FDA target action date; approval is not assured. Primary source dated 2026-09-08; checked 2026-10-04.Confirmed datePrimary source
2027-03-10$NTLAIntellia Therapeutics, Inc.lonvo-z (NTLA-2002), HAE. BLA accepted with Priority Review; FDA target action date, not approval.Confirmed datePrimary source
2027-03-11$BMYBRISTOL MYERS SQUIBBReblozyl (luspatercept) — myelofibrosis-associated anemia. FDA target action date: 2027-03-11.Confirmed datePrimary source
2027-03-22$MRKMerck & Co., Inc.Enflonsia (clesrovimab-cfor) — children entering a second RSV season at increased risk. FDA target action date: 2027-03-22.Confirmed datePrimary source
2027-04-01$HRMYHarmony Biosciences Holdings, Inc.pitolisant GR — narcolepsy. FDA target action date: 2027-04-01.Confirmed datePrimary source
14 April 2027$INBXINHIBRX BIOSCIENCES INCPDUFA: ozekibart (INBRX-109) · Conventional chondrosarcoma. Company timing: 14 April 2027. FDA target action date; approval is not assured. Primary source dated 2026-08-13; checked 2026-10-04.Confirmed datePrimary source
2027-04-23$PHVSPharvaris N.V.deucrictibant IR — on-demand treatment of hereditary angioedema attacks. FDA target action date: 2027-04-23.Confirmed datePrimary source
2027-04-23$RPRXRoyalty Pharma plcdeucrictibant IR — hereditary angioedema; royalty interest. FDA target action date: 2027-04-23.Confirmed datePrimary source
2027-04-24$ORGOOrganogenesis Holdings Inc.ReNu — symptomatic knee osteoarthritis. FDA target action date: 2027-04-24.Confirmed datePrimary source
2027-04-28$IMNMIMMUNOME, INC.varegacestat — desmoid tumors in adults. FDA target action date: 2027-04-28.Confirmed datePrimary source
2027-05-01$AXSMAxsome Therapeutics, Inc.AXS-12 (reboxetine) — narcolepsy. FDA target action date: 2027-05-01.Confirmed datePrimary source
2027-05-08$BBIOBridgeBio Pharma, Inc.encaleret — autosomal dominant hypocalcemia type 1. FDA target action date: 2027-05-08.Confirmed datePrimary source
2027-05-13$BMYBRISTOL MYERS SQUIBBmezigdomide with carfilzomib and dexamethasone — relapsed/refractory multiple myeloma. FDA target action date: 2027-05-13.Confirmed datePrimary source
2027-05-27$ZBIOZenas BioPharma, Inc.obexelimab — IgG4-related disease. FDA target action date: 2027-05-27.Confirmed datePrimary source
2027-06-24$UTHRUNITED THERAPEUTICS CORPORATIONralinepag — pulmonary arterial hypertension. FDA target action date: 2027-06-24.Confirmed datePrimary source
2027-06-29$COGTCogent BiosciencesBezuclastinib NDA in advanced systemic mastocytosis (AdvSM): FDA target action date June 29, 2027, announced September 15. Separate from GIST November 30 and nonadvanced SM December 30, 2026. Approval is not assured.Confirmed datePrimary source

Clinical and corporate events with a confirmed day: 15 events

Date / windowTickerCompanyEventStatusSources
2026-10-05$BLFSBioLife Solutions / RepligenBioLife shareholder vote on Repligen merger, 09:00 ET / 15:00 Europe/Rome. Closing remains conditional.Confirmed datePrimary source
2026-10-08$BBIOBridgeBio PharmaCommercial Day in New York City: commercial readiness and launch strategy across three planned launches. Corporate event, not an FDA decision. Time not specified in the source.Confirmed datePrimary source
9 October 2026$ANIPANI PHARMACEUTICALS INCSYNCHRONICITY Phase 4 results for fluocinolone acetonide intravitreal implant in chronic non-infectious posterior-segment uveitis: late-breaking oral presentation at AAO Uveitis Subspecialty Day, October 9 at 4:50 p.m. ET. NEW DAY post-hoc analyses in diabetic macular edema will also be available as an on-demand ePoster; a separate poster day is not specified. Company timing: 9 October 2026. Congress: AAO Annual Meeting. Primary source dated 2026-09-30; checked 2026-10-04.Confirmed datePrimary source
Supporting source
2026-10-20$ANABAnaptysBioPost-trial hearing in GSK/Tesaro Jemperli litigation. Hearing date is not judgment date.Confirmed datePrimary source
2026-10-23$ALNYAlnylam Pharmaceuticals, Inc.ALN-HTT02 Phase 1 initial results at EHDN; presentation date October 23, 2026 announced in Q2 results.Confirmed datePrimary source
2026-10-24$CMPXCompass Therapeutics, Inc.COMPANION-002 tovecimig oral presentation at ESMO 2026. CONFIRMED DATE, presentation time not confirmed here. Compass Therapeutics will present results of the randomized Phase 2/3 COMPANION-002 trial of tovecimig plus paclitaxel in advanced biliary tract cancer at ESMO on 24 October 2026.Confirmed datePrimary source
24 October 2026$PBLSPARABILIS MEDICINES INCConference presentation: zolucatetide · desmoid tumor (Phase 1/2). Company timing: 24 October 2026. Congress: ESMO Congress. Primary source dated 2026-09-15; checked 2026-10-04.Confirmed datePrimary source
Congress schedule
25 October 2026$ANABANAPTYSBIO INCConference presentation: Jemperli (dostarlimab) · Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer AZUR-1 (pivotal Phase 2). Company timing: 25 October 2026. Congress: ESMO Congress. Primary source dated 2026-09-21; checked 2026-10-04.Confirmed datePrimary source
Congress schedule
2026-10-25$GSKGSK / AnaptysBioAZUR-1 dostarlimab Phase 2 first-results presentation at ESMO, Madrid; distinct from FDA review.Confirmed datePrimary source
2026-10-25$SMMTSummit Therapeutics / AkesoHARMONi-GI1 Phase 3 biliary-tract cancer presentation, ESMO Presidential Symposium II, LBA8. Session 16:30-18:15 CET / 11:30-13:15 EDT; individual talk time not announced. Akeso-sponsored study conducted in China. Separate from the November 14 NSCLC PDUFA.Confirmed datePrimary source
2 November 2026$RXRXRECURSION PHARMACEUTICALS INCConference presentation: REC-4881 · Familial adenomatous polyposis. Company timing: 2 November 2026. Congress: CGA-IGC Annual Meeting. Primary source dated 2026-08-05; checked 2026-10-04.Confirmed datePrimary source
Supporting source
November 8, 2026$CGEMCullinan Therapeutics, Inc.Velinotamig: multidose data from the Genrix Bio Phase 1 dose-escalation study in systemic lupus erythematosus, poster presentation at ACR Convergence on November 8, 2026, 10:30 a.m.–12:30 p.m. Eastern.Confirmed datePrimary source
8 November 2026$MLYSMINERALYS THERAPEUTICS INCTransform-HTN open-label extension: long-term efficacy and safety of lorundrostat in uncontrolled hypertension. Late-breaking AHA Scientific Sessions presentation on November 8 at 3:30 p.m. CT, Chicago. This is a clinical presentation, separate from the December PDUFA target. Company timing: 8 November 2026. Congress: AHA Scientific Sessions. Primary source dated 2026-09-23; checked 2026-10-04.Confirmed datePrimary source
Supporting source
November 9, 2026$ARTVArtiva Biotherapeutics, Inc.AlloNK (AB-101) plus rituximab updated Phase 2a basket data in refractory RA, Sjögren disease and systemic sclerosis at ACR 2026. Oral session November 9, 3:00-4:30 pm EST; investor webcast 8:15 am EST.Confirmed datePrimary source
November 10, 2026$ARTVArtiva Biotherapeutics, Inc.AlloNK (AB-101) plus rituximab safety and B-cell depletion data from a 60-patient rheumatology cohort, ACR poster 2384 November 10, 10:30 am-12:30 pm EST. Separate poster from the November 9 oral efficacy update; overlapping patients are possible.Confirmed datePrimary source

Conferences with a confirmed range: 21 events

The range refers to the conference dates. Any confirmed individual presentation day is stated in the row; other presentation days are not inferred from the conference start.

Date / windowTickerCompanyEventStatusSources
8–11 October 2026$ATTOATTOVIA THERAPEUTICS INCATTO-1310 Phase 1b interim efficacy and safety poster in atopic dermatitis or chronic pruritus at Fall Clinical Dermatology Conference. The EADV posters concern separate healthy-volunteer and translational datasets. Company timing: 8–11 October 2026. Congress: Fall Clinical Dermatology Conference 2026. The conference range does not establish the individual presentation day. Primary source dated 2026-09-28; checked 2026-10-04.Conference rangePrimary source
8–11 October 2026$ATTOATTOVIA THERAPEUTICS INCPreclinical characterization of ATTO-2306, a long-acting bispecific antibody targeting IL-13 and IL-31, presented at Fall Clinical Dermatology Conference. Company timing: 8–11 October 2026. Congress: Fall Clinical Dermatology Conference 2026. The conference range does not establish the individual presentation day. Primary source dated 2026-09-28; checked 2026-10-04.Conference rangePrimary source
ECNP Congress 2026-10-10–2026-10-13$GHRSGH RESEARCH PLCConference presentation: mebufotenin (GH001) · TRD Treatment-resistant depression (Phase 2b). Company timing: ECNP Congress 2026-10-10–2026-10-13. Congress: ECNP Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-06; checked 2026-10-04.Conference rangePrimary source
Trial registry
Congress schedule
15–16 October 2026$TSHATAYSHA GENE THERAPIES INCTSHA-102 REVEAL Part A Phase 1/2 safety and efficacy results in Rett syndrome: encore oral and poster presentations on October 15 at the Child Neurology Society meeting. Company-hosted symposium on October 16. These sessions repeat previously shared IRSF data rather than announce a new readout. Company timing: 15–16 October 2026. Primary source dated 2026-10-01; checked 2026-10-04.Estimated windowPrimary source
UEG Week 2026-10-17–2026-10-20$ABVXABIVAX SAConference presentation: obefazimod. Company timing: UEG Week 2026-10-17–2026-10-20. Congress: UEG Week. The conference range does not establish the individual presentation day. Primary source dated 2026-09-21; checked 2026-10-04.Conference rangePrimary source
Supporting source
October 21-23, 2026 conference; presentation day unspecified$KYTXKyverna Therapeutics, Inc.KYSA-8 miv-cel full one-year dataset presentation at MS Toronto. CONFIRMED October 21-23, 2026 conference; presentation day unspecified. October 21 is the conference-start marker, not a confirmed presentation day. Exclude from exact-day confirmed table unless range can be displayed explicitly.Estimated windowPrimary source
MSToronto Joint ACTRIMS-ECTRIMS Congress 2026-10-21–2026-10-23$ZBIOZENAS BIOPHARMA INCConference presentation: orelabrutinib. Company timing: MSToronto Joint ACTRIMS-ECTRIMS Congress 2026-10-21–2026-10-23. Congress: MSToronto Joint ACTRIMS-ECTRIMS Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-13; checked 2026-10-04.Conference rangePrimary source
Supporting source
ESMO Congress 2026-10-23–2026-10-27$BHVNBIOHAVEN LTDConference presentation: BHV-1530 · Advanced solid tumors (Phase 1). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-10; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$GENBGENERATE BIOMEDICINES INCConference presentation: GB-4362 · locally advanced or metastatic urothelial cancer (Phase 1). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-06; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$HCMHUTCHMED (CHINA) LTDConference presentation: ORPATHYS (savolitinib) plus TAGRISSO (osimertinib). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-09-29; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$HCMHUTCHMED (CHINA) LTDSANOVO Phase III savolitinib plus osimertinib results selected for an oral Proffered Paper presentation at ESMO. Separate from the SAFFRON Presidential Symposium presentation. Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-09-24; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$IDYAIDEAYA BIOSCIENCES INCConference presentation: IDE849 (DLL3 TOP1i ADC) · SCLC small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) (Phase 1). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-04; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$IDYAIDEAYA BIOSCIENCES INCConference presentation: darovasertib combination (Phase 2). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-04; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$IDYAIDEAYA BIOSCIENCES INCConference presentation: darovasertib · Primary uveal melanoma; Metastatic uveal melanoma. Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-04; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$INBXINHIBRX BIOSCIENCES INCConference presentation: INBRX-106 · HNSCC locally advanced recurrent or metastatic HNSCC; Head and neck squamous cell carcinoma The data were reported in a filing of Sep 8, 2026; this slot presents them. (Phase 2). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-03-19; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$IOVAIOVANCE BIOTHERAPEUTICS INCConference presentation: Amtagvi (lifileucel) · UPS and DDLPS (registrational). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-06; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$ORICORIC PHARMACEUTICALS INCConference presentation: enozertinib · 1L NSCLC with EGFR atypical mutations. Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-03; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$TNGXTANGO THERAPEUTICS INCConference presentation: vopimetostat · PDAC Pancreatic cancer (Phase 1/2). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-11; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$XNCRXENCOR INCConference presentation: XmAb819 · RCC Clear cell renal cell carcinoma (Phase 1). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-05; checked 2026-10-04.Conference rangePrimary source
Congress schedule
ESMO Congress 2026-10-23–2026-10-27$ZLABZAI LAB LTDConference presentation: zocilurtatug pelitecan · SCLC first-line SCLC; Extensive-Stage Small Cell Lung Cancer (Phase 1). Company timing: ESMO Congress 2026-10-23–2026-10-27. Congress: ESMO Congress. The conference range does not establish the individual presentation day. Primary source dated 2026-08-06; checked 2026-10-04.Conference rangePrimary source
Congress schedule
November 16-19, 2026 conference; presentation day unspecified$ACADAcadia Pharmaceuticals Inc.RADIANT Phase 2 remlifanserin detailed safety and efficacy oral presentation at CTAD. CONFIRMED November 16-19, 2026 conference; presentation day unspecified. November 16 is the conference-start marker, not a confirmed presentation day. Primary endpoint was not statistically met. Exclude from exact-day confirmed table unless conference range is explicit.Conference rangePrimary source
Supporting source

Company windows and explicit estimates: 452 events

Quarters, half-years and other windows are company guidance, not exact dates. Estimates derived from a regulatory review duration are labeled as calculated. A window-end marker is not an announced readout day. Filings, study starts and results are different milestones.

Date / windowTickerCompanyEventStatusSources
October 2026$IVVDInvivyd, Inc.VYD2311 DECLARATION placebo-controlled safety and neutralizing-antiviral-titer topline expected in October 2026. This is a month window and 31 October is a conventional end marker, not a company-announced day. Clinical efficacy events remain blinded and a BLA is only planned, subject to supportive data.Estimated windowPrimary source
October 2026$MIRMMirum Pharmaceuticals / IncyteAtebrioz US commercial launch expected October 2026; exact day not announced. ESTIMATED window: October 2026.Estimated windowPrimary source
October 2026$PCVXVAXCYTE INCTopline data: VAX-31 OPUS-1. Company timing: October 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-03; checked 2026-10-04.Estimated windowPrimary source
October 2026$RAPPRAPPORT THERAPEUTICS INCTopline data: RAP-219 · Bipolar mania (Phase 2). Company timing: October 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
October 2026$TLSATiziana Life Sciences Ltd.INFORM-MS foralumab 12-week topline. ESTIMATED window: October 2026. 2026-10-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
October 2026$TRDATRDAENTR-601-45: ELEVATE-45-201 Cohort 1 multiple-ascending-dose data (5 mg/kg) in exon-45-skipping-amenable Duchenne muscular dystrophy, expected in October 2026. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
Around November 1, 2026 (calculated)$QUREuniQure N.V.AMT-130 BLA filing-review decision window. ESTIMATED Around November 1, 2026 (calculated). November 1 is calculated from 60 calendar days after the September 2 submission; the issuer did not announce an exact decision day. Priority review was requested, not granted. This is not a PDUFA deadline.Estimated windowPrimary source
ACAAI Annual Scientific Meeting 2026-11-12–2026-11-16$ADMAADMA BIOLOGICS INCASCENIV real-world outcomes abstract submitted to ACAAI. Acceptance and an individual presentation date are not confirmed by the cited release. Company timing: ACAAI Annual Scientific Meeting 2026-11-12–2026-11-16. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Congress: ACAAI Annual Scientific Meeting. The conference range does not establish the individual presentation day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Supporting source
17 October–16 November 2026$RAREUltragenyx Pharmaceutical Inc.FAYUVI commercial product expected available to ship to qualified treatment centers within 30-60 days of September 17 approval: October 17-November 16, 2026. November 16 is a conventional end-of-window marker, not a confirmed shipment date, patient treatment or recognized revenue.Estimated windowPrimary source
September–November 2026$ACADACADIA PHARMACEUTICALS INCTopline data: DAYBUE (trofinetide) · RTT Rett syndrome. Company timing: September–November 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
End of November 2026$MLTXMoonLake ImmunotherapeuticsSonelokimab HS BLA acceptance, Priority Review decision and PDUFA date allocation. ESTIMATED End of November 2026. Conditional on planned filing; November 30 is an indicative marker, not an announced PDUFA date.Estimated windowPrimary source
Supporting source
November 2026$RHHBYRoche Holding AGGazyva/Gazyvaro (obinutuzumab): FDA decision window in primary membranous nephropathy. ESTIMATED November 2026. Priority Review is confirmed, but the issuer states November, not a specific day.Estimated windowPrimary source
Late November 2026$SLGLSol-Gel Technologies Ltd.SGT-610 (patidegib gel 2%), pivotal Phase 3 in Gorlin syndrome. September 17 company update reports last patient last visit and expects topline results in late November 2026. November 30 is a conventional end-of-window marker, not an exact readout date. Registry completion is a separate milestone.Estimated windowPrimary source
2026$AAPGASCENTAGE PHARMA GROUP INTERNATIONALInitial data: APG-3288 (Phase 1). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-01-15; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ABCLABCELLERA BIOLOGICS INCTopline data: ABCL575 (Phase 1). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ABSIABSCI CORPInterim data: ABS-201 · PHL. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Late 2026$ABVXABIVAX SANDA/BLA submission: obefazimod · UC Ulcerative colitis (Phase 3). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-21; checked 2026-10-04.Estimated windowPrimary source
By year-end 2026$ADMAADMA BIOLOGICS INCFDA meeting: SG-001 · Streptococcus pneumoniae infection. Company timing: By year-end 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2026$AGIOAGIOS PHARMACEUTICALS INCTopline data: tebapivat · SCD Sickle Cell Disease (Phase 2). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-04-29; checked 2026-10-04.Estimated windowPrimary source
H2 2026$AGIOAGIOS PHARMACEUTICALS INCInitial data: AG-181 · PKU Phenylketonuria (PKU) (Phase 1b). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
Late 2026$ALKSALKERMES PLCNDA/BLA submission: LUMRYZ (sodium oxybate) · Idiopathic hypersomnia (Phase 3). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-12; checked 2026-10-04.Estimated windowPrimary source
Late 2026$ALKSALKERMES PLCTopline data: alixorexton · Idiopathic hypersomnia (phase 2). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-28; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ALNYAlnylam Pharmaceuticals, Inc.ALN-6400 Phase 1/2 and ALN-2232 Phase 1 readouts expected H2 2026; October 1 is an indicative placement, not an announced clinical date.Estimated windowPrimary source
Late 2026$ALVOALVOTECHPotential regulatory decision (company forecast): Biologics License Applications. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-19; checked 2026-10-04.Estimated windowPrimary source
2026$ALVOALVOTECHRegulatory decision: relevant BLAs. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-11; checked 2026-10-04.Estimated windowPrimary source
Late 2026$AMLXAMYLYX PHARMACEUTICALS INCNDA/BLA submission: avexitide · Post-bariatric hypoglycemia. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-18; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ANIPANI PHARMACEUTICALS INCTopline data: ILUVIEN · chronic non-infectious uveitis affecting the posterior segment of the eye (NIU-PS) SYNCHRONICITY (Phase 4). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
By year-end 2026$ARCTArcturus Therapeutics Holdings Inc.ARCT-2601 integration into the ongoing OTC-deficiency Phase 2 study. ESTIMATED By year-end 2026. Company plan following the September 23 ARCT-810 interim announcement; regulatory and operational execution remain prospective.Estimated windowPrimary source
Q4 2026$ARQTARCUTIS BIOTHERAPEUTICS INCClinical data readout: ZORYVE foam 0.3% · Vitiligo (Phase 2). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Late 2026$ARWRARROWHEAD PHARMACEUTICALS INCNDA/BLA submission: REDEMPLO (plozasiran) · sHTG severe hypertriglyceridemia (sHTG). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ATAIATAIBECKLEY INCInitial data: BPL-003 · TRD treatment-resistant depression (TRD) (Phase 2a). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-12; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ATAIATAIBECKLEY INCTopline data: VLS-01 · TRD (Phase 2). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-12; checked 2026-10-04.Estimated windowPrimary source
H2 2026$AVBPARRIVENT BIOPHARMA INCARR-217 Phase 1 dose-escalation completion and transition to dose optimization. No interim-results publication is promised by this milestone. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-05; checked 2026-10-04.Estimated windowPrimary source
H2 2026$AVBPARRIVENT BIOPHARMA INCTopline data: firmonertinib · first-line EGFR exon 20 insertion mutant NSCLC (Phase 3). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q4 2026$AXSMAXSOME THERAPEUTICS INCTopline data: solriamfetol · Binge eating disorder ENGAGE (Phase 3). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$BCAXBICARA THERAPEUTICS INCInitial data: ficerafusp alfa · 3L+ mCRC (RAS/BRAF wild type MSS); mCRC (RAS/BRAF wild type MSS) (Phase 1b). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-11; checked 2026-10-04.Estimated windowPrimary source
by end of 2026$BCRXBioCryst Pharmaceuticals, Inc.BCX17725 Phase 1 Part 4 data in Netherton syndrome. ESTIMATED by end of 2026. Up to 12 patients followed for three months; no exact release day.Estimated windowPrimary source
2026$BEAMBEAM THERAPEUTICS INCFull data: BEAM-302 · AATD alpha-1 antitrypsin deficiency (AATD). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
Late 2026$BEAMBEAM THERAPEUTICS INCClinical data readout: ristoglogene autogetemcel (risto-cel) · SCD sickle cell disease (SCD) BEACON (Phase 1/2). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2026$BEAMBEAM THERAPEUTICS INCInitial data: BEAM-301 · glycogen storage disease type Ia (GSDIa) (Phase 1/2). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2026$BHVNBIOHAVEN LTDTopline data: opakalim · Focal epilepsy (pivotal). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$BHVNBIOHAVEN LTDTopline data: taldefgrobep alfa · Obesity (Phase 2). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$BIOABioAge Labs, Inc.QUELL-CV BGE-102 Phase 2 topline in cardiovascular risk. ESTIMATED H2 2026. December 31 is an indicative marker. Enrollment completed; timing guidance reaffirmed September 8.Estimated windowPrimary source
Supporting source
Q4 2026$CELCCELCUITY INCClinical data readout: REVTORPYK (gedatolisib) · Metastatic castration-resistant prostate cancer (Phase 2). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
December 2026$CGEMCullinan Therapeutics, Inc.CLN-049: updated Phase 1 dose-escalation data with longer follow-up in relapsed/refractory acute myeloid leukemia, expected in December 2026. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
December 2026$CGEMCullinan Therapeutics, Inc.CLN-978: concurrent multidose and single-target-dose clinical data in systemic lupus erythematosus, rheumatoid arthritis and Sjögren's disease, expected in December 2026. One planned package across three indications. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
2026$CGONCG ONCOLOGY INCBOND-003 Cohort P durability data in high-risk BCG-unresponsive Ta/T1 non-muscle-invasive bladder cancer without carcinoma in situ. Cohort C and CORE-008 Cohort A data are represented separately. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-27; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$CGONCG ONCOLOGY INCNDA/BLA submission: cretostimogene · HR BCG-unresponsive NMIBC. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Late 2026$CLDXCELLDEX THERAPEUTICS INCTopline data: barzolvolimab · AtD Atopic dermatitis (Phase 2). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$CLYMClimb Bio, Inc.CLYM116 additional Phase 1 and Mabworks initial healthy-volunteer data. ESTIMATED Q4 2026. Planned for a medical meeting in Q4; meeting and presentation date not named. December 31 is a window-end marker.Estimated windowPrimary source
Supporting source
2026$COGTCOGENT BIOSCIENCES INCIND submission: CGT1145. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-05; checked 2026-10-04.Estimated windowPrimary source
2026$COGTCOGENT BIOSCIENCES INCInitial data: CGT4859 (Phase 1). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-17; checked 2026-10-04.Estimated windowPrimary source
2026$COGTCOGENT BIOSCIENCES INCIND submission: CGT1815 · Cancer. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Late 2026$COGTCOGENT BIOSCIENCES INCPreliminary results from the SUMMIT extension cohort switching patients from avapritinib to bezuclastinib. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$CRSPCRISPR Therapeutics AGCTX310 Phase 1b severe hypertriglyceridemia cohort clinical update. ESTIMATED H2 2026. Distinct from the Phase 1a one-year durability data already presented at ESC on August 28.Estimated windowPrimary source
H2 2026$CRSPCRISPR THERAPEUTICS AGClinical data readout: CTX611 (SRSD107) · Thromboembolic and clotting-related indications (Phase 2). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-04; checked 2026-10-04.Estimated windowPrimary source
H2 2026$CRSPCRISPR THERAPEUTICS AGClinical data readout: zugocabtagene geleucel (zugo-cel; formerly CTX112™) · SLE B-cell malignancies; systemic lupus erythematosus, systemic sclerosis, inflammatory myositis, immune thrombocytopenic purpura, and warm autoimmune hemolytic anemia (Phase 1/2). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-04; checked 2026-10-04.Estimated windowPrimary source
2026$CRSPCRISPR THERAPEUTICS AGPreclinical program update: CTX321™ · elevated lipoprotein(a) [Lp(a)]. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-12; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$CYTKCYTOKINETICS INCNDA/BLA submission: MYQORZO (aficamten) · symptomatic nHCM (Phase 3). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-28; checked 2026-10-04.Estimated windowPrimary source
2026$DFTXDEFINIUM THERAPEUTICS INCInitial data: MM402 (R(-)-MDMA) · Autism Spectrum Disorder (Phase 2a). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-19; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$DFTXDefinium TherapeuticsDT120 ODT — pre-NDA meeting scheduled in Q4 2026. December 31 is the conventional end of the October–December window, not the exact meeting date.Estimated windowPrimary source
H2 2026$DMRADAMORA THERAPEUTICS INCIND submission: DMR-002. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$DMRADAMORA THERAPEUTICS INCRegulatory submissions to expand the Phase 1/1b DMR-001 trial globally in essential thrombocythemia and myelofibrosis. These are trial authorizations, not marketing applications. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
December 2026$DNTHDIANTHUS THERAPEUTICS INCTopline data: claseprubart · Multifocal motor neuropathy (Phase 2). Company timing: December 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Late 2026$DNTHDIANTHUS THERAPEUTICS INCInitial data: DNTH212 · SLE Systemic Lupus Erythematosus (Phase 1). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Late 2026$DRTSALPHA TAU MEDICAL LTDPMA submission: Alpha DaRT · cutaneous squamous cell carcinoma ReSTART. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-01-29; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026$DRTSALPHA TAU MEDICAL LTDInterim data: Alpha DaRT · GBM glioblastoma multiforme REGAIN. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ELDNEledon Pharmaceuticals, Inc.LEGACY Phase 3 kidney-transplant trial initiation. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
H2 2026$ERASERASCA INCInitial data: ERAS-4001 · RAS-mutant solid tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ETONETON PHARMACEUTICALS INCTopline data: ET-700 · Wilson disease. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-14; checked 2026-10-04.Estimated windowPrimary source
Late 2026$ETONETON PHARMACEUTICALS INCNDA/BLA submission: AMGLIDIA®. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$EWTXEDGEWISE THERAPEUTICS INCGRAND CANYON pivotal cohort topline results in Becker muscular dystrophy. Servier acquired sevasemten and the muscular-dystrophy business in July 2026; Edgewise retains exposure through contingent milestone payments. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Servier-owned program; EWTX contingent milestone exposure. Primary source dated 2026-07-13; checked 2026-10-04.Estimated windowPrimary source
Trial registry
later in 2026$GOSSGossamer Bio, Inc.FDA filing-acceptance review of seralutinib NDA. ESTIMATED later in 2026. Issuer expects this could occur later this year. No PDUFA announced; timing is not a guaranteed Q4 appointment.Estimated windowPrimary source
Q4 2026$GPCRSTRUCTURE THERAPEUTICS INCResults from the Phase 2 aleniglipron study in adults with type 2 diabetes and obesity or overweight. Separate from the 44-week body-composition study. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q4 2026$GPCRSTRUCTURE THERAPEUTICS INCResults from the 44-week Phase 2 body-composition trial of aleniglipron, evaluating body fat and overall body composition. This is separate from the Phase 2 diabetes study. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q4 2026$GRFSGRIFOLS SATopline data: alpha-1 antitrypsin · Emphysema SPARTA (Phase 3). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-29; checked 2026-10-04.Estimated windowPrimary source
H2 2026$HCMHUTCHMED (CHINA) LTDClinical trial initiation: HMPL-A830 · Solid tumors. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
2026$HCMHUTCHMED (CHINA) LTDIND submission: ATTC candidates. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2025-10-23; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$HRMYHARMONY BIOSCIENCES HOLDINGS INCTopline data: BP-205 (Phase 1). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$HROWHARROW INCTopline data: NATACYN · fungal keratitis. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$HROWHARROW INCTopline data: IHEEZO · patients undergoing intravitreal injections QUELL (Phase 4). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IDYAIDEAYA BIOSCIENCES INCNDA/BLA submission: darovasertib in combination with crizotinib · Metastatic uveal melanoma (registrational). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2026$IDYAIDEAYA BIOSCIENCES INCConference presentation: IDE397 · MTAP-deleted urothelial cancer (UC) (Phase 1/2). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-17; checked 2026-10-04.Estimated windowPrimary source
Late 2026$IMCRIMMUNOCORE HOLDINGS PLCTopline data: KIMMTRAK (tebentafusp) · previously treated advanced melanoma. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-14; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IMCRIMMUNOCORE HOLDINGS PLCIND submission: IMC-U120AI · AtD Atopic dermatitis; autoimmune candidate. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IMCRIMMUNOCORE HOLDINGS PLCConference presentation: IMC-P115C · solid tumors; Multiple solid tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IMCRIMMUNOCORE HOLDINGS PLCConference presentation: brenetafusp · solid tumors; ovarian and lung cancer (Phase 1/2). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
Late 2026$IMNMIMMUNOME INCIND submission: IM-1335. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
2026$IMNMIMMUNOME INCIND submission: solid tumor-targeted ADC programs · Solid tumors. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-03; checked 2026-10-04.Estimated windowPrimary source
2026$IMNMIMMUNOME INCInitial data: IM-1021 · B-cell lymphoma (Phase 1). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Late 2026$IMNMIMMUNOME INCMarketing authorization application: varegacestat (formerly AL102). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IMTXIMMATICS NVInitial data: IMA402 · melanoma and gynecologic cancers (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-05; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IMTXIMMATICS NVClinical data readout: IMA203CD8 · Gynecologic cancers (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-06-01; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H2 2026$IMVTIMMUNOVANT INCClinical program update: imeroprubart (IMVT-1402) · RA Difficult-to-treat rheumatoid arthritis (potentially registrational). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H2 2026$IMVTIMMUNOVANT INCTopline data: imeroprubart (IMVT-1402) · RA Cutaneous lupus erythematosus; Rheumatoid arthritis. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q4 2026$INBXINHIBRX BIOSCIENCES INCFDA meeting: ozekibart (INBRX-109) · CRC Colorectal cancer (Phase 1). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
2026$IOVAIOVANCE BIOTHERAPEUTICS INCConference presentation: Amtagvi (lifileucel) · metastatic non-squamous NSCLC. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
2026$IOVAIOVANCE BIOTHERAPEUTICS INCRegulatory decision: Amtagvi (lifileucel) · Advanced melanoma. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$IPHAInnate Pharma S.A.PACIFIC-9 Phase 3 monalizumab readout. ESTIMATED window: H2 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Late 2026$IRONDISC MEDICINE INCInitial data: DISC-3405 · SCD Sickle cell disease (Phase 1b). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-10; checked 2026-10-04.Estimated windowPrimary source
Late 2026$IRONDISC MEDICINE INCFDA meeting: selcodebart (DISC-0974) · anemia of MF (Phase 2). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-10; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$IRONDISC MEDICINE INCTopline data: bitopertin · EPP. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$IVAInventiva S.A.NATiV3 Phase 3 lanifibranor topline in MASH. ESTIMATED Q4 2026. Last patient visit completed; exact readout day unannounced.Estimated windowPrimary source
2026$JANXJANUX THERAPEUTICS INCFull data: JANX008 · Solid tumors (Phase 1). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-26; checked 2026-10-04.Estimated windowPrimary source
H2 2026$JANXJanux Therapeutics, Inc.JANX011 Phase 1 initial clinical data in healthy volunteers. ESTIMATED H2 2026. December 31 is an indicative marker. Healthy-volunteer data are not efficacy data in autoimmune patients.Estimated windowPrimary source
Q4 2026$KODKodiak SciencesZenkuda multi-indication BLA submission planned. ESTIMATED window: Q4 2026. Five positive Phase 3 studies across wet AMD, diabetic retinopathy and retinal vein occlusion. This is a planned submission, not an accepted filing, approval or PDUFA date.Estimated windowPrimary source
December 2026$KODKodiak SciencesKSI-101 PEAK Phase 3 Pivotal Analysis 1 topline in macular edema secondary to inflammation, first 300-patient cohort. ESTIMATED window: December 2026. No exact release day; separate from registry primary completion and Pivotal Analysis 2.Estimated windowPrimary source
Supporting source
Late 2026$KRYSKRYSTAL BIOTECH INCInterim data: KB407 · CF Cystic Fibrosis (Phase 1). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H2 2026$KRYSKRYSTAL BIOTECH INCNDA/BLA submission: VYJUVEK (beremagene geperpavec) · Dystrophic Epidermolysis Bullosa. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$KRYSKRYSTAL BIOTECH INCTopline data: beremagene geperpavec-svdt (KB803) · corneal abrasions in DEB patients (registrational). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026$KRYSKRYSTAL BIOTECH INCTopline data: KB801 · Neurotrophic keratitis (registrational). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-04; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q4 2026$KRYSKRYSTAL BIOTECH INCFDA meeting: KB407 · CF Cystic fibrosis (registrational). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026$KRYSKRYSTAL BIOTECH INCFDA meeting: KB111 · Hailey-Hailey disease (HHD). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
2026$KRYSKRYSTAL BIOTECH INCInterim data: KB707 · Gorlin syndrome (Phase 1/2). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026$KRYSKRYSTAL BIOTECH INCInterim data: KB111 · Hailey-Hailey Disease. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026$KYMRKYMERA THERAPEUTICS INCTopline data: KT-621 · AtD Atopic dermatitis (Phase 2b). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-06-25; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$KYMRKYMERA THERAPEUTICS INCClinical data readout: KT-579 (Phase 1). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$KYTXKyverna Therapeutics, Inc.miv-cel rolling BLA submission completion in SPS. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
H2 2026$LEGNLEGEND BIOTECH CORPInitial data: dual CD20/CD19-targeted cell therapy. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-01-12; checked 2026-10-04.Estimated windowPrimary source
H2 2026$LGNDLIGAND PHARMACEUTICALS INCNDA/BLA submission: Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) · microcystic lymphatic malformations (microcystic LMs); MLM. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
H2 2026$LGNDLIGAND PHARMACEUTICALS INCTopline data: ersodetug · Tumor hyperinsulinism (Phase 3). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
2026$LQDALIQUIDIA CORPPlanned completion of the ASCENT open-label study assessing 52 weeks of YUTREPIA treatment in pulmonary hypertension associated with interstitial lung disease. Completion is not an announced public data-release date. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-01-09; checked 2026-10-04.Estimated windowPrimary source
H2 2026$MANEVERADERMICS INCTopline data: VDPHL01 · Male pattern hair loss (Phase 3). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$MBXMBX BIOSCIENCES INCFirst-cohort results from the 12-week multiple-ascending-dose portion of the Phase 1 MBX 4291 obesity trial. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$MBXMBX BIOSCIENCES INCConference presentation: MBX 6180. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2026$MGTXMEIRAGTX HOLDINGS PLCIND submission: native human leptin (Ribo-Leptin) · Metabolic disease. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-14; checked 2026-10-04.Estimated windowPrimary source
2026$MGTXMEIRAGTX HOLDINGS PLCNDA/BLA submission: botaretigene sparoparvovec · RP X-linked retinitis pigmentosa. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$MIRMMirum Pharmaceuticals, Inc.Brelovitug AZURE-4, the second pivotal chronic hepatitis delta study, topline expected in Q4 2026. 31 December is a conventional quarter-end marker; AZURE-1 results released on 28 September are a distinct study.Estimated windowPrimary source
Q4 2026$MIRMMirum Pharmaceuticals, Inc.LIVMARLI EXPAND Phase 3 topline. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
By year-end 2026$MNKDMANNKIND CORPIND submission: Ralinepag DPI (MNKD-1501). Company timing: By year-end 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Late 2026$NAMSNEWAMSTERDAM PHARMA CO NVTopline data: obicetrapib · T2D Type 2 diabetes or metabolic syndrome (Phase 3). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2026$NBTXNANOBIOTIX SAFull data: NBTXR3 · NSCLC (Phase 2). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-20; checked 2026-10-04.Estimated windowPrimary source
H2 2026$NKTRNEKTAR THERAPEUTICSConference presentation: NKTR-0165 (preclinical). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
2026$NRIXNURIX THERAPEUTICS INCConference presentation: bexobrutideg · Relapsed or refractory B-cell malignancies (Phase 1a/1b). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-09; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2026$NRIXNURIX THERAPEUTICS INCIND submission: bexobrutideg · Autoimmune and inflammatory diseases (Phase 1). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-04-08; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026$NUVBNUVATION BIO INCPreclinical drug-drug-conjugate platform update as Nuvation explores new candidates. No clinical patient-data release is specified. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$NVCRNOVOCURE LTDRegulatory decision: TTFields therapy · NSCLC Brain metastases from non-small cell lung cancer. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-23; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$OCULOcular Therapeutix, Inc.AXPAXLI wet AMD NDA submission with interim SOL-R safety analysis. ESTIMATED Q4 2026. Guidance reaffirmed after completed pre-NDA meeting. Submission is neither FDA acceptance nor approval. Primary issuer release syndicated on Nasdaq.Estimated windowPrimary source
Late 2026$OPKOPKO HEALTH INCIND submission: long-acting PTH tablet · Hypoparathyroidism. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-04-28; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ORICORIC PHARMACEUTICALS INCInitial data: enozertinib · NSCLC 1L EGFR exon 20 insertion NSCLC; NSCLC; Non-small cell lung cancer. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ORICORIC PHARMACEUTICALS INCRinzimetostat program update. The source does not specify an interim clinical-data release. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ORKAOruka Therapeutics, Inc.ORKA-004: planned entry into clinical development of the extended-half-life anti-TL1A antibody in Q4 2026. Phase 2 combination studies are a separate future milestone. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
Q4 2026$ORKAOruka Therapeutics, Inc.EVERLAST-B ORKA-001 Week 16 data. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
December 2026$ORKAOruka Therapeutics, Inc.EVERLAST-A ORKA-001 Week 52 data. ESTIMATED window: December 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Around mid-Q4 2026$OSTXOS Therapies IncorporatedOST-HER2 confirmatory Phase 3 initiation. ESTIMATED window: around mid-Q4 2026. 2026-11-15 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q4 2026$PBLSPARABILIS MEDICINES INCFDA meeting: zolucatetide · Desmoid tumors (Phase 3). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Late 2026$PCRXPACIRA BIOSCIENCES INCTopline data: ZILRETTA · Osteoarthritis pain of the shoulder (Phase 3). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-04-30; checked 2026-10-04.Estimated windowPrimary source
Late 2026$PCRXPACIRA BIOSCIENCES INCTopline data: enekinragene inzadenovec (PCRX-201) · Osteoarthritis of the knee (Phase 2). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2026$PCRXPACIRA BIOSCIENCES INCNDA/BLA submission: EXPAREL. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-26; checked 2026-10-04.Estimated windowPrimary source
By year-end 2026$PGENPRECIGEN INCPRGN-2009 pipeline update in HPV-driven cancers; the quoted guidance does not specify a clinical-data release. Company timing: By year-end 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$PRAXPraxis Precision MedicinesRelutrigine EMERALD Phase 3 topline in broad developmental and epileptic encephalopathies. ESTIMATED window: Q4 2026. Separate from the December 27 SCN2A/SCN8A PDUFA and registry completion dates.Estimated windowPrimary source
Q4 2026$PTCTPTC THERAPEUTICS INCRolling NDA/BLA submission: ST-920 · Fabry disease (BLA-stage). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-21; checked 2026-10-04.Estimated windowPrimary source
H2 2026$PTCTPTC THERAPEUTICS INCFDA meeting: votoplam · HD Huntington's disease (Phase 3). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
H2 2026$PVLAPALVELLA THERAPEUTICS INCRolling NDA/BLA submission: sirolimus (QTORIN rapamycin) · Microcystic lymphatic malformations (NDA). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$RAPPRAPPORT THERAPEUTICS INCInitial data: RAP-219 RAP-219. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$RAREULTRAGENYX PHARMACEUTICAL INCClinical data readout: rivunatpagene miziparvovec · Wilson disease Cyprus2+ (pivotal). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2026$RCUSARCUS BIOSCIENCES INCClinical data readout: casdatifan · ccRCC. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
2026$REPLREPLIMUNE GROUP INCFull data: TUDRIQEV (vusolimogene oderparepvec-wtpg) · Skin cancers; CSCC ARTACUS (Phase 1b/2). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-14; checked 2026-10-04.Estimated windowPrimary source
Late 2026$REPLREPLIMUNE GROUP INCInitial data: RP2 (sturlimgene erparepvec) · HCC Hepatocellular carcinoma. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-14; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$RGNXREGENXBIO Inc.ATMOSPHERE and ASCENT pivotal surabgene lomparvovec topline in wet AMD. ESTIMATED Q4 2026. Distinct from registry primary-completion markers. December 31 is not an announced release day.Estimated windowPrimary source
Late 2026$RLAYRELAY THERAPEUTICS INCZovegalisib: regulatory feedback to confirm the planned Phase 3 design in first-line endocrine-sensitive breast cancer, expected by year-end 2026. This is not a marketing-approval decision. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Late 2026$RLAYRELAY THERAPEUTICS INCZovegalisib: clinical data and regulatory update for the vascular-anomalies program, expected by year-end 2026. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$RXRXRECURSION PHARMACEUTICALS INCFDA meeting: REC-4881 · FAP. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2026$RXRXRECURSION PHARMACEUTICALS INCInterim data: REC-1245 (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
2026$RZLTRezolute, Inc.upLIFT ersodetug topline in tumor hyperinsulinism expected before end of 2026; enrollment ongoing. December 31 is a conventional window-end marker, not an announced release day. Separate from sunRIZE congenital HI and registry completion.Estimated windowPrimary source
2026$SANASana Biotechnology, Inc.SC451 IND filing and Phase 1/2 trial start goal. ESTIMATED 2026. Company goal, conditional on nonclinical, manufacturing and regulatory execution. This event does not set a date for SG293 data.Estimated windowPrimary source
Q4 2026$SCYXSCYNEXIS, Inc.SCY-770 Phase 2 proof-of-concept initiation. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Supporting source
Q4 2026$SLSSELLAS LIFE SCIENCES GROUP INCTopline data: tambiciclib · AML (Phase 2). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q4 2026$SNDXSyndax Pharmaceuticals, Inc.MAXPIRe axatilimab Phase 2 topline in idiopathic pulmonary fibrosis. ESTIMATED Q4 2026. December 31 is an indicative window-end marker, not a confirmed results date.Estimated windowPrimary source
Supporting source
Late 2026$SNDXSYNDAX PHARMACEUTICALS INCIND submission: SNDX-4321 · NSCLC Non-small cell lung cancer. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$SNDXSYNDAX PHARMACEUTICALS INCFull data: Revuforj (revumenib) · NUP98r acute leukemia. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2026$SNDXSYNDAX PHARMACEUTICALS INCConference presentation: Revuforj (revumenib). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$SNDXSyndax Pharmaceuticals, Inc.Axatilimab plus ruxolitinib Phase 2 topline in newly diagnosed chronic GVHD. ESTIMATED Q4 2026. December 31 is an indicative marker; distinct from Phase 3 corticosteroid combination.Estimated windowPrimary source
Supporting source
H2 2026$SRPTSAREPTA THERAPEUTICS INCSRP-1001: further multiple-ascending-dose data from the ongoing Phase 1/2 trial in facioscapulohumeral muscular dystrophy (FSHD), expected in H2 2026. These are early clinical results, with no precise release day announced. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Supporting source
H2 2026$SRPTSAREPTA THERAPEUTICS INCSRP-1003: further multiple-ascending-dose data from the ongoing Phase 1/2 trial in myotonic dystrophy type 1 (DM1), expected in H2 2026. These are early clinical results, with no precise release day announced. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Supporting source
Late 2026$SRRKSCHOLAR ROCK HOLDING CORPTopline data: SRK-439 (Phase 1). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$STOKSTOKE THERAPEUTICS INCFDA meeting: zorevunersen · DS Dravet syndrome (Phase 3). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$SYRESPYRE THERAPEUTICS INCTopline data: SPY072 · PsA psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-25; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$TCRXTScan Therapeutics, Inc.ALLOHA Phase 1 Cohort C updated TSC-101 clinical data. ESTIMATED Q4 2026. Data guidance maintained despite a pause in further Phase 3 ALLOHA-2 enrollment; this is not Phase 3 topline.Estimated windowPrimary source
Q4 2026$TEVATeva Pharmaceutical Industries LimitedTEV-'749 olanzapine LAI PDUFA decision. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
H2 2026$TGTXTG THERAPEUTICS INCNDA/BLA submission: BRIUMVI (ublituximab-xiiy). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-27; checked 2026-10-04.Estimated windowPrimary source
H2 2026$TGTXTG THERAPEUTICS INCInitial data: azer-cel · Progressive MS (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$TNGXTANGO THERAPEUTICS INCInitial data: TNG456 · GBM Glioblastoma. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-06-08; checked 2026-10-04.Estimated windowPrimary source
H2 2026$TNGXTANGO THERAPEUTICS INCVopimetostat monotherapy data in lung cancer. Separate from the pancreatic-cancer combination data scheduled for ESMO. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$TRAXFIRST TRACKS BIOTHERAPEUTICS INCTopline data: ANB033 · Celiac disease (Phase 1b). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
By year-end 2026$TRDATRDAENTR-601-44: open-label follow-up from ELEVATE-44-201 Cohort 1 (6 mg/kg), assessing longer-term safety and functional measures in exon-44-skipping-amenable Duchenne muscular dystrophy, expected by year-end 2026. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
H2 2026$TRDATRDAVX-670: partner Vertex expects multiple-ascending-dose results from GALILEO Phase 1/2 in myotonic dystrophy type 1 in H2 2026, covering safety, muscle-biopsy splicing and preliminary functional measures. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
Q4 2026$TRVITREVI THERAPEUTICS INCLAKE Phase 2b refractory-chronic-cough study: sample-size re-estimation analysis after half the participants complete treatment. This is an operational interim analysis, not the final topline efficacy readout. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2026$TVTXTRAVERE THERAPEUTICS INCNDA/BLA submission: FILSPARI (sparsentan) · Japan. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-19; checked 2026-10-04.Estimated windowPrimary source
Late 2026$URGNUROGEN PHARMA LTDIND submission: UGN-501 · NMIBC High-grade non-muscle invasive bladder cancer. Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-02; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$VERAVera TherapeuticsTRUTAKNA full-approval sBLA submission planned Q4 2026. December 31 is a conventional end-of-window marker, not an exact company date or PDUFA.Estimated windowPrimary source
Q4 2026$VERAVERA THERAPEUTICS INCAdditional Phase 2 PIONEER atacicept data in a broader IgA-nephropathy population and other autoimmune kidney diseases. Separate from the completed ORIGIN 3 eGFR analysis. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H2 2026$VIRVIR BIOTECHNOLOGY INCInterim data: VIR-5818 · Solid tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$VIRVIR BIOTECHNOLOGY INCTopline data: elebsiran and tobevibart · HDV Chronic hepatitis delta (Phase 3). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H2 2026$VRDNVIRIDIAN THERAPEUTICS INCInitial data: VRDN-008 (phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$VRDNVIRIDIAN THERAPEUTICS INCIND submission: anti-TSHR candidate · Graves' disease and TED. Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2026$VRDNVIRIDIAN THERAPEUTICS INCDevelopment program update: VRDN-006. Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$XNCRXENCOR INCConference presentation: XmAb541 (CLDN6 x CD3) · Advanced gynecologic and germ cell tumors (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-01-08; checked 2026-10-04.Estimated windowPrimary source
H2 2026$XNCRXENCOR INCClinical program update: XmAb657 (CD19 x CD3) · Idiopathic inflammatory myopathies (Phase 1). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-25; checked 2026-10-04.Estimated windowPrimary source
Late 2026$XNCRXENCOR INCInterim data: XmAb942 (Xtend TL1A) · UC ulcerative colitis (UC) (Phase 2b). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$XNCRXENCOR INCNDA/BLA submission: obexelimab · Immunoglobulin G4-related disease. Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$XRTXXORTX Therapeutics Inc.XRx-026 gout IND submission. ESTIMATED window: Q4 2026. 2026-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
By year-end 2026$ZBIOZENAS BIOPHARMA INCInitial data: ZB021 (Phase 1). Company timing: By year-end 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Q4 2026$ZBIOZENAS BIOPHARMA INCTopline data: obexelimab · SLE Systemic lupus erythematosus (Phase 2). Company timing: Q4 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ZBIOZENAS BIOPHARMA INCMarketing authorization application: obexelimab · Immunoglobulin G4-Related Disease (IgG4-RD). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Late 2026$ZLABZAI LAB LTDIND submission: ZL-1311 (Phase 1). Company timing: Late 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ZLABZAI LAB LTDInitial data: ZL-1503 (IL-13/IL-31R) · AtD Atopic dermatitis (Phase 1/1b). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2026$ZYMEZYMEWORKS INCConference presentation: pasritamig · Advanced prostate cancer (Phase 1b). Company timing: H2 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2026$ZYMEZYMEWORKS INCIND submission: ZW209 (Phase 1). Company timing: 2026. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
February 2027$ANABANAPTYSBIO INCPDUFA: Jemperli (dostarlimab) · Untreated stage II/III dMMR/MSI-H locally advanced rectal cancer AZUR-1 (pivotal). Company timing: February 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. FDA target action date; approval is not assured. Primary source dated 2026-09-21; checked 2026-10-04.Estimated windowPrimary source
February 2027$GSKGSK / AnaptysBioJemperli rectal-cancer FDA action target communicated as February 2027 only; potential earlier review through National Priority Voucher. Exact day not disclosed. ESTIMATED window: February 2027.Estimated windowPrimary source
Early 2027$ACIUAC Immune SAFDA discussions on the future development path and Part 2 design of VacSYn, the Phase 2 trial of ACI-7104 in early Parkinson's disease. ESTIMATED window: early 2027. March 31 is a conventional end-of-window marker, not an announced meeting date. Not ACI-24.060 or ABATE. | Sources: ; | Checked: 2026-09-27Estimated windowPrimary source
Supporting source
Q1 2027$AEMDAethlon Medical, Inc.NOR-101 Phase 1a start, proposed merger. ESTIMATED window: Q1 2027. 2027-03-31 is an indicative date within or at the end of that window, not a company-announced event day. Aethlon/North merger is proposed and conditional; NRTX is only a proposed future ticker.Estimated windowPrimary source
Q4 2026 or Q1 2027$ANABAnaptysBio / GSKJemperli litigation judgment anticipated Q4 2026 or Q1 2027; exact day unknown.Estimated windowPrimary source
Q1 2027$ATYRaTyr Pharma, Inc.EFZO-CONNECT efzofitimod Phase 2 topline in systemic sclerosis-related ILD. ESTIMATED Q1 2027. March 31 is an indicative marker. September 24 update addresses sarcoidosis protocol and does not replace this SSc-ILD readout guidance.Estimated windowPrimary source
Supporting source
Q1 2027$BMEABiomea Fusion, Inc.COVALENT-211 Phase 2 icovamenib Week 26 primary-endpoint topline in type 2 diabetes. ESTIMATED Q1 2027. Enrollment completed; company readout guidance separate from registry primary completion.Estimated windowPrimary source
Q1 2027$DYNDYNE THERAPEUTICS INCTopline data: zeleciment basivarsen (DYNE-101) · DM1 myotonic dystrophy type 1 (DM1) (Phase 1/2). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-29; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q1 2027$FLNAFilana Therapeutics, Inc.simufilam TSC epilepsy Phase 2a screening. ESTIMATED window: Q1 2027. 2027-03-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q1 2027$INBXINHIBRX BIOSCIENCES INCInterim data: ozekibart (INBRX-109) · CRC Colorectal cancer (Phase 1). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$IPHAInnate Pharma S.A.TELLOMAK-3 lacutamab first patient. ESTIMATED window: Q1 2027. 2027-03-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q1 2027$LGNDLIGAND PHARMACEUTICALS INCTopline data: volixibat · PBC cholestatic pruritus due to primary biliary cholangitis (PBC) VANTAGE (Phase 2b). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$MIRAMIRA Pharmaceuticals, Inc.Ketamir-2 Phase 2a site initiation. ESTIMATED window: Q1 2027. 2027-03-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q1 2027$MIRMMIRUM PHARMACEUTICALS INCTopline data: volixibat · PBC Cholestatic pruritus due to primary biliary cholangitis VANTAGE (Phase 2b). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$NAMSNEWAMSTERDAM PHARMA CO NVInterim data: obicetrapib (Phase 3). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
early 2027$NKTRNektar TherapeuticsPlanned registrational Phase 3 rezpegaldesleukin study initiation in alopecia areata. ESTIMATED early 2027. Early 2027 is company guidance; March 31 is only a conventional marker, not a promised deadline.Estimated windowPrimary source
Q1 2027$NKTRNEKTAR THERAPEUTICSTopline data: rezpegaldesleukin · AtD Moderate-to-severe atopic dermatitis. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-12; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$OCGNOcugen, Inc.OCU400 Phase 3 liMeliGhT topline in retinitis pigmentosa. ESTIMATED Q1 2027. March 31 is an indicative window-end marker. The Bahamas provisional authorization is separate from FDA approval.Estimated windowPrimary source
Q1 2027$ORKAORUKA THERAPEUTICS INCORKA-002: Week 16 data from ORCA-SURGE, the Phase 2 trial in moderate-to-severe plaque psoriasis, expected in Q1 2027 after accelerated guidance. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$PALIPalisade Bio, Inc.ASCENTRA-CD Phase 2 Crohn's first patient. ESTIMATED window: Q1 2027. 2027-03-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q1 2027$PBLSPARABILIS MEDICINES INCClinical data readout: zolucatetide · FAP. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$PHVSPHARVARIS NVCREAATE Phase 3 Part 1 topline results for deucrictibant XR prevention of attacks of acquired angioedema due to C1-inhibitor deficiency. This is not the CHAPTER-3 hereditary-angioedema trial. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q1 2027$REPLREPLIMUNE GROUP INCPlanned transition of the REVEAL registration-directed RP2 study from Phase 2 to Phase 3 in metastatic uveal melanoma. This does not specify a public interim-data release. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-14; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$RNACCartesian Therapeutics, Inc.Descartes-08 AURORA Phase 3 generalized myasthenia gravis data expected Q1 2027 per company guidance. Distinct from the ClinicalTrials.gov primary-completion estimate; 31 March is a conventional quarter-end marker.Estimated windowPrimary source
Q1 2027$SEPNSEPTERNA INCInitial data: SEP-479 · Hypoparathyroidism (Phase 1). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$SRPTSAREPTA THERAPEUTICS INCELEVIDYS: 12-week data from the full ENDEAVOR Cohort 8, expected in Q1 2027. Full cohort enrollment is separately expected by year-end 2026; no exact readout day is announced. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$STOKSTOKE THERAPEUTICS INCRolling NDA/BLA submission: zorevunersen · DS Dravet syndrome (Phase 3). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Year-end 2026 / Q1 2027$TGTXTG THERAPEUTICS INCTopline data: subcutaneous BRIUMVI (ublituximab) (Phase 3). Company timing: Year-end 2026 / Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$TRAXFIRST TRACKS BIOTHERAPEUTICS INCTopline data: ANB033 · Celiac disease (Phase 1b). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$TRDATRDAENTR-601-44: ELEVATE-44-201 Cohort 2 multiple-ascending-dose data (12 mg/kg), expected in Q1 2027. Distinct from Cohort 1 open-label follow-up. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
Q1 2027$TYRATYRA BIOSCIENCES INCInitial data: oral dabogratinib · Achondroplasia (Phase 2). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$VIRVIR BIOTECHNOLOGY INCTopline data: elebsiran and tobevibart · HDV Chronic hepatitis delta (Phase 3). Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q1 2027$VRDNVIRIDIAN THERAPEUTICS INCNDA/BLA submission: elegrobart · TED Thyroid eye disease. Company timing: Q1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Q1 2027$XENEXenon Pharmaceuticals Inc.X-NOVA2 azetukalner Phase 3 MDD topline. ESTIMATED window: Q1 2027. 2027-03-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Mid-2027$CCCCC4 Therapeutics, Inc.Cemsidomide plus elranatamab Phase 1b data from all evaluated cohorts expected mid-2027. June 15 is a conventional marker for mid-year, not a company-announced day or precise quarter. Separate from Phase 1 dexamethasone data presented September 25, 2026.Estimated windowPrimary source
Early 2027$ABSIABSCI CORPTopline data: ABS-201 · PHL; Pattern hair loss. Company timing: Early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H1 2027$AZNAstraZeneca PLCefzimfotase alfa PDUFA action for hypophosphatasia. ESTIMATED window: H1 2027. 2027-06-30 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
H1 2027$BHCBAUSCH HEALTH COMPANIES INCPotential regulatory decision (company forecast): lumify (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-04-30; checked 2026-10-04.Estimated windowPrimary source
Q2 2027$BMEABiomea Fusion, Inc.COVALENT-212 Phase 2 icovamenib Week 26 primary-endpoint topline on background GLP-1 therapy. ESTIMATED Q2 2027. Enrollment still ongoing in the source release; date remains guidance.Estimated windowPrimary source
H1 2027$CLYMClimb Bio, Inc.CLYM116 NAVIGATE-2 Phase 2 initial data in IgA nephropathy. ESTIMATED H1 2027. June 30 is a window-end marker; study evaluates Q8W/Q12W dosing.Estimated windowPrimary source
Late 2026 / early 2027$COAGHEMAB THERAPEUTICS HOLDINGS INCClinical data readout: sutacimig · Factor VII deficiency (Phase 2). Company timing: Late 2026 / early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Late 2026 / early 2027$COAGHEMAB THERAPEUTICS HOLDINGS INCInterim data: HMB-002 · Von Willebrand disease (Phase 1/2). Company timing: Late 2026 / early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H1 2027$CRMDCorMedix TherapeuticsREZZAYO prophylaxis: potential FDA action subject to filing acceptance. ESTIMATED H1 2027. Conditional company guidance, not a confirmed PDUFA date.Estimated windowPrimary source
H1 2027$DFTXDefinium TherapeuticsDT120 ODT — NDA submission planned in 1H 2027. June 30 is a conventional end-of-window marker, not an exact submission date, PDUFA or approval.Estimated windowPrimary source
H1 2027$DNLIDENALI THERAPEUTICS INCClinical data readout: DNL151 (LRRK2 inhibitor) · PD Parkinson's disease (Phase 2a). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$DNLIDENALI THERAPEUTICS INCInitial data: DNL628 · AD Alzheimer's disease (Phase 1b). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Early 2027$DRTSALPHA TAU MEDICAL LTDInitial data: Alpha DaRT · PDAC pancreatic cancer IMPACT. Company timing: Early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-31; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Late 2026 / early 2027$DRTSALPHA TAU MEDICAL LTDTopline data: Alpha DaRT · cutaneous squamous cell carcinoma ReSTART. Company timing: Late 2026 / early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H1 2027$ERASERASCA INCInterim data: ERAS-0015. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Q2 2027$ETONETON PHARMACEUTICALS INCRegulatory decision: KHINDIVI (hydrocortisone). Company timing: Q2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-14; checked 2026-10-04.Estimated windowPrimary source
H1 2027$GPCRSTRUCTURE THERAPEUTICS INCTopline data: ACCG-2671. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
Supporting source
Early 2027$HRMYHARMONY BIOSCIENCES HOLDINGS INCTopline data: BP-205 · Sleep-deprived healthy volunteers (Phase 1b). Company timing: Early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H1 2027$HRMYHARMONY BIOSCIENCES HOLDINGS INCTopline data: EPX-100 (clemizole hydrochloride) · DS/LGS rare epilepsies; Dravet syndrome; Lennox-Gastaut syndrome (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Early 2027$HROWHARROW INCTopline data: TRIESENCE · ocular inflammation and pain following cataract surgery (Phase 3). Company timing: Early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
H1 2027$HROWHARROW INCPlanned MELT-300 NDA submission following completion of the nonclinical and pharmacokinetic studies needed for the application. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-02; checked 2026-10-04.Estimated windowPrimary source
Late 2026 / early 2027$IDYAIDEAYA BIOSCIENCES INCInitial data: IDE034 (B7H3/PTK7 bispecific TOP1i ADC) (Phase 1). Company timing: Late 2026 / early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Early 2027$IMCRIMMUNOCORE HOLDINGS PLCInterim data: IMC-M113V (Phase 1/2). Company timing: Early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$IMTXIMMATICS NVTopline data: anzutresgene autoleucel (anzu-cel, IMA203) · Unresectable or metastatic melanoma (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-18; checked 2026-10-04.Estimated windowPrimary source
H1 2027$IOVAIOVANCE BIOTHERAPEUTICS INCRegulatory decision: Amtagvi (lifileucel) · melanoma. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$IOVAIOVANCE BIOTHERAPEUTICS INCInitial data: Amtagvi (lifileucel) · cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$IVAInventiva S.A.Planned lanifibranor regulatory submission following NATiV3. ESTIMATED H1 2027. Conditional on favorable NATiV3 results; filing is not approval.Estimated windowPrimary source
H1 2027$JANXJanux Therapeutics, Inc.JANX007 additional clinical data at a future medical congress. ESTIMATED H1 2027. June 30 is an indicative marker. Congress and presentation day are not identified.Estimated windowPrimary source
H1 2027$KARDKARDIGAN INCTopline data: Tonlamarsen · Acute severe hypertension (Phase 2). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H1 2027$KARDKARDIGAN INCTopline data: Danicamtiv · Genetic dilated cardiomyopathy (Phase 2b). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H1 2027$KARDKARDIGAN INCTopline data: Ataciguat · Calcific aortic valve stenosis (Phase 2b). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Q2 2027$KODKodiak SciencesKSI-101 BLA submission planned. ESTIMATED window: Q2 2027. Company forward-looking plan dependent on development and regulatory execution; no exact filing day, acceptance, approval or PDUFA date announced.Estimated windowPrimary source
H1 2027$KRYSKRYSTAL BIOTECH INCInterim data: KB707 · Solid tumors of the lung (Phase 1/2). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H1 2027$LBRXLB PHARMACEUTICALS INCTopline data: LB-102 · SCZ Schizophrenia NOVA-2 (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-15; checked 2026-10-04.Estimated windowPrimary source
Q2 2027$LGNDLIGAND PHARMACEUTICALS INCTopline data: avim therapy. Company timing: Q2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
H1 2027$MANEVERADERMICS INCTopline data: VDPHL01 · Female pattern hair loss (Phase 2/3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Late 2026 / early 2027$MAZEMAZE THERAPEUTICS INCInterim data: MZE829 · broad AMKD patients; AMKD; APOL1-mediated kidney disease (Phase 2). Company timing: Late 2026 / early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-17; checked 2026-10-04.Estimated windowPrimary source
Q2 2027$MGTXMEIRAGTX HOLDINGS PLCClinical data readout: AAV2-hAQP1 · Radiation-induced xerostomia (pivotal Phase 2). Company timing: Q2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H1 2027$MIRMMirum Pharmaceuticals, Inc.Company expects to submit a brelovitug BLA for chronic hepatitis delta to FDA in H1 2027. This is a half-year window; 30 June is a conventional marker, not a filing confirmation.Estimated windowPrimary source
H1 2027$MIRMMIRUM PHARMACEUTICALS INCNDA/BLA submission: volixibat · PSC cholestatic pruritus due to PSC; Primary sclerosing cholangitis. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H1 2027$MLTXMoonLake ImmunotherapeuticsIZAR-1 sonelokimab Phase 3 full Week 52 readout in psoriatic arthritis. ESTIMATED H1 2027. The trial remains blinded through Week 52. June 30 is a conventional window-end marker.Estimated windowPrimary source
Early 2027$NKTRNektar TherapeuticsZENITH AA Phase 3 rezpegaldesleukin study in alopecia areata expected to initiate in early 2027. ESTIMATED window: early 2027; June 30 CSV date is only a conservative conventional window-end marker, not an announced start day.Estimated windowPrimary source
Q2 2027$OCGNOcugen, Inc.OCU400 planned BLA submission for retinitis pigmentosa. ESTIMATED Q2 2027. June 30 is an indicative window-end marker; planned filing is not FDA acceptance or approval.Estimated windowPrimary source
H1 2027$OPKOPKO HEALTH INCInitial data: MDX2004 (Phase 1). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-27; checked 2026-10-04.Estimated windowPrimary source
Late 2026 / early 2027$OPKOPKO HEALTH INCInitial data: MDX2301 · COVID-19 Prevention of COVID-19 (Phase 1). Company timing: Late 2026 / early 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-27; checked 2026-10-04.Estimated windowPrimary source
H1 2027$PBLSPARABILIS MEDICINES INCClinical data readout: zolucatetide · ACP. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
H1 2027$PCVXVAXCYTE INCClinical data readout: VAX-31 · Invasive pneumococcal disease and pneumonia OPUS-2 OPUS-3 (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-03; checked 2026-10-04.Estimated windowPrimary source
H1 2027$PHVSPHARVARIS NVNDA/BLA submission: deucrictibant XR (PHVS719) · HAE CHAPTER-3 (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H1 2027$PVLAPALVELLA THERAPEUTICS INCRegulatory decision: sirolimus (QTORIN rapamycin) · Microcystic lymphatic malformations (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-20; checked 2026-10-04.Estimated windowPrimary source
H1 2027$QUREUNIQURE NVConference presentation: AMT-260 · Refractory mesial temporal lobe epilepsy (Phase I/IIa). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-29; checked 2026-10-04.Estimated windowPrimary source
H1 2027$RAREULTRAGENYX PHARMACEUTICAL INCTopline data: avalotcagene ontaparvovec · Ornithine Transcarbamylase deficiency Enh3ance (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H1 2027$RCUSARCUS BIOSCIENCES INCClinical data readout: quemliclustat · PDAC Metastatic pancreatic ductal adenocarcinoma (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H1 2027$RLAYRELAY THERAPEUTICS INCZovegalisib plus atirmociclib and endocrine therapy: Phase 1/2 triplet clinical-data update in breast cancer, expected in H1 2027. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$RXRXRECURSION PHARMACEUTICALS INCInterim data: REC-3565 (Phase 1). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$RXRXRECURSION PHARMACEUTICALS INCInterim data: REC-617 (Phase 1). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$RXRXRECURSION PHARMACEUTICALS INCInitial data: REC-4881 · FAP; Familial adenomatous polyposis (Phase 1b/2). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-25; checked 2026-10-04.Estimated windowPrimary source
H1 2027$SCTXScribe Therapeutics Inc.STX-1150 Phase 1 initial single-ascending-dose clinical data. ESTIMATED H1 2027. Planned data include safety, tolerability and LDL-C lowering. June 30 is a window-end marker.Estimated windowPrimary source
H1 2027$STOKSTOKE THERAPEUTICS INCInitial data: STK-002 · ADOA; autosomal dominant optic atrophy ("ADOA") OSPREY (Phase 1). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
H1 2027$TARSTARSUS PHARMACEUTICALS INCTP-04 lotilaner ophthalmic-gel Phase 2 KORE topline results in ocular rosacea. TP-05/Calliope is a separate oral Lyme-disease prevention program. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Q2 2027$TCRXTScan Therapeutics, Inc.TSC-101 update on patients treated with the commercial-ready manufacturing process. ESTIMATED Q2 2027. Company continues patient follow-up despite enrollment pause; exact day not announced.Estimated windowPrimary source
H1 2027$TLXTELIX PHARMACEUTICALS LTDCOMPOSE Phase 3 second interim analysis of ITM-11 in G2/G3 somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors. Telix announced an agreement to acquire ITM; closing remained subject to conditions in the September 21 source. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. ITM program; announced Telix acquisition pending closing. Primary source dated 2026-09-21; checked 2026-10-04.Estimated windowPrimary source
Trial registry
H1 2027$TRDATRDAENTR-601-45: ELEVATE-45-201 Cohort 2 multiple-ascending-dose data at 10 mg/kg, expected in H1 2027. Distinct from ELEVATE-44-201 Cohort 2. Exact event day is not announced. CSV Date is a conventional window-end marker.Estimated windowPrimary source
H1 2027$TSHATAYSHA GENE THERAPIES INCTopline data: TSHA-102 · RTT Rett syndrome REVEAL (pivotal). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H1 2027$VORVOR BIOPHARMA INCTopline data: telitacicept · gMG Generalized myasthenia gravis (Phase 3). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H1 2027$XNCRXENCOR INCInitial data: XmAb412 · Autoimmune and inflammatory disease. Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H1 2027$ZLABZAI LAB LTDInitial data: ZL-1503 (IL-13/IL-31R) · AtD Atopic dermatitis (Phase 1/1b). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$ZLABZAI LAB LTDTopline data: ZL-6201 · sarcoma and selected tumors (Phase 1a/b). Company timing: H1 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H1 2027$ZNTLZentalis Pharmaceuticals, Inc.DENALI Part 2 integrated azenosertib topline in Cyclin E1-positive platinum-resistant ovarian cancer. ESTIMATED H1 2027. June 30 is an indicative marker. Potential accelerated-approval support is conditional, not approval.Estimated windowPrimary source
Supporting source
Mid-2027$AEMDAethlon Medical, Inc.NOR-101 Phase 1a interim PK and safety data, proposed merger. ESTIMATED window: mid-2027. 2027-07-15 is an indicative date within or at the end of that window, not a company-announced event day. Aethlon/North merger is proposed and conditional; NRTX is only a proposed future ticker.Estimated windowPrimary source
Mid-2027$COAGHemab Therapeutics Holdings, Inc.HMB-003 initial clinical data. ESTIMATED window: mid-2027. 2027-07-15 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Mid-2027$JAGXJaguar Health, Inc.crofelemer MVID NDA filing. ESTIMATED window: mid-2027. 2027-07-15 is an indicative date within or at the end of that window, not a company-announced event day. Subject to study completion and regulatory alignment.Estimated windowPrimary source
Mid-2027$KYTXKyverna Therapeutics, Inc.KYSA-6 Phase 3 miv-cel enrollment completion. ESTIMATED window: mid-2027. 2027-07-15 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q3 2027$ACADACADIA PHARMACEUTICALS INCTopline data: ACP-211 · MDD Major depressive disorder (Phase 2). Company timing: Q3 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-26; checked 2026-10-04.Estimated windowPrimary source
Q3 2027$BCRXBIOCRYST PHARMACEUTICALS INCTopline data: navenibart · HAE Hereditary angioedema (pivotal). Company timing: Q3 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Q3 2027$DYNDYNE THERAPEUTICS INCNDA/BLA submission: zeleciment basivarsen (DYNE-101) · DM1 myotonic dystrophy type 1 (DM1) (Phase 1/2). Company timing: Q3 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-29; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Q3 2027$STOKSTOKE THERAPEUTICS INCClinical data readout: zorevunersen · DS Dravet syndrome (Phase 3). Company timing: Q3 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Q3 2027$TRAXFIRST TRACKS BIOTHERAPEUTICS INCTopline data: ANB033 · EoE Eosinophilic esophagitis ANB033 (Phase 1b). Company timing: Q3 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
2027$ABCLABCELLERA BIOLOGICS INCIND submission: ABCL688 · Autoimmunity. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2027$ABSIABSCI CORPInterim data: ABS-201 · Endometriosis HEADLINE (Phase 2). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$ABVXABIVAX SATopline data: obefazimod · CD Crohn's disease (Phase 2b). Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-21; checked 2026-10-04.Estimated windowPrimary source
2027$ALKSALKERMES PLCClinical data readout: ALKS 7290 · ADHD attention-deficit hyperactivity disorder (ADHD) (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-21; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2027$ALMRALAMAR BIOSCIENCES INCDevice marketing authorization submission: ARGO HT/DX instrument. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H2 2027$ALTAltimmune, Inc.RESTORE Phase 2 pemvidutide topline in alcohol-associated liver disease. ESTIMATED H2 2027. Enrollment completed in July 2026. Topline concerns updated 48-week endpoint, not enrollment. Window-end marker is not an announced release day.Estimated windowPrimary source
2027$AMLXAMYLYX PHARMACEUTICALS INCIND submission: AMX0318 · PBH and other rare diseases. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2027$AVLNAVALYN PHARMA INCTopline data: ap01 (inhaled pirfenidone) · Progressive pulmonary fibrosis (Phase 2b). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
Late 2027$AVLNAVALYN PHARMA INCTopline data: ap02 (inhaled nintedanib) · IPF Idiopathic pulmonary fibrosis (Phase 2). Company timing: Late 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
2027$AXSMAXSOME THERAPEUTICS INCTopline data: solriamfetol · Shift work disorder SUSTAIN (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$BCAXBICARA THERAPEUTICS INCInterim data: ficerafusp alfa · 1L R/M HPV-negative HNSCC FORTIFI-HN01 (Phase 3). Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Late 2027$BCRXBIOCRYST PHARMACEUTICALS INCNDA/BLA submission: navenibart. Company timing: Late 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H2 2027$BIOABioAge Labs, Inc.QUELL-DME BGE-102 Phase 2 topline in diabetic macular edema. ESTIMATED H2 2027. December 31 is an indicative marker. Primary endpoint is BCVA change at week 12.Estimated windowPrimary source
H2 2027$BRVEBRAVEHEART BIO INCInterim data: BHB-1893 · obstructive HCM ("oHCM") (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
2027$CLDXCelldex Therapeutics, Inc.barzolvolimab CSU BLA submission. ESTIMATED window: 2027. 2027-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
2027$CNMDCONMED CORPClinical data readout: BioBrace · rotator cuff. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-01-12; checked 2026-10-04.Estimated windowPrimary source
2027$DFTXDEFINIUM THERAPEUTICS INCTopline data: DT120 ODT · MDD Major depressive disorder (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$DMRADAMORA THERAPEUTICS INCInitial data: DMR-001 · Essential thrombocythemia and myelofibrosis; ET and MF. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
2027$DMRADAMORA THERAPEUTICS INCIND submission: DMR-003. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-10; checked 2026-10-04.Estimated windowPrimary source
2027$DNLIDENALI THERAPEUTICS INCInitial data: DNL952 · Pompe disease (Phase 1). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$DNLIDENALI THERAPEUTICS INCClinical data readout: DNL921 · AD Alzheimer's disease (Phase 1/1b). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$DNLIDENALI THERAPEUTICS INCClinical data readout: DNL593 · granulin ( GRN )-related frontotemporal dementia (FTD- GRN ) (Phase 1/2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$DNLIDENALI THERAPEUTICS INCNDA/BLA submission: zafinofusp alfa (DNL126; ETV:SGSH) · Sanfilippo syndrome type A (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
By year-end 2027$DNTHDIANTHUS THERAPEUTICS INCDNTH312 development target is Phase 1 readiness by year-end 2027. The quoted statement does not establish an IND filing date or first-patient dosing date. Company timing: By year-end 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2027$ETONETON PHARMACEUTICALS INCNDA/BLA submission: ASN-001 · Moderate infantile hemangiomas. Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
Q4 2027$HCMHUTCHMED (CHINA) LTDTopline data: IMG-007 · AtD moderate-to-severe atopic dermatitis (Phase IIb). Company timing: Q4 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2027$HRMYHARMONY BIOSCIENCES HOLDINGS INCTopline data: Pitolisant HD · Narcolepsy; Idiopathic hypersomnia; Narcolepsy (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$HRMYHARMONY BIOSCIENCES HOLDINGS INCPitolisant (WAKIX): topline data from the Phase 3 TEMPO study in Prader-Willi syndrome are expected around mid-2027. This is distinct from pitolisant GR in narcolepsy. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$IDYAIDEAYA BIOSCIENCES INCInterim data: darovasertib combination · Metastatic uveal melanoma. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2027$IMCRIMMUNOCORE HOLDINGS PLCInitial data: IMC-R117C · CRC advanced solid tumors, including colorectal cancer (Phase 1/2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
2027$IMTXIMMATICS NVIMA401 (MAGEA4/8) plus IMA402 (PRAME): first clinical data from the combination cohort in squamous non-small-cell lung cancer expected in 2027. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-18; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2027$IMTXIMMATICS NVAnzu-cel BLA submission planned in 2027 after final SUPRAME progression-free-survival topline data expected in the first half of 2027. The newer August guidance no longer specifies a first-half filing deadline. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-18; checked 2026-10-04.Estimated windowPrimary source
2027$IMVTIMMUNOVANT INCTopline data: imeroprubart (IMVT-1402) · Graves' disease (potentially registrational). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2027$IMVTIMMUNOVANT INCTopline data: imeroprubart (IMVT-1402) · gMG Myasthenia gravis (potentially registrational). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Mid-2027 (approximate)$INBXINHIBRX BIOSCIENCES INCInitial data: INBRX-106 · NSCLC Non-small cell lung cancer (Phase 1/2). Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
H2 2027$IONSIONIS PHARMACEUTICALS INCClinical data readout: obudanersen · Angelman syndrome REVEAL (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-29; checked 2026-10-04.Estimated windowPrimary source
2027$IONSIONIS PHARMACEUTICALS INCNDA/BLA submission: ZANVASTRO (zilganersen). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-04; checked 2026-10-04.Estimated windowPrimary source
2027$IOVAIOVANCE BIOTHERAPEUTICS INCMarketing authorization resubmission: Amtagvi (lifileucel) · Advanced melanoma. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$IRONDISC MEDICINE INCRegulatory decision: bitopertin · EPP. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
2027$IRONDISC MEDICINE INCInitial data: selcodebart (DISC-0974) · IBD Inflammatory bowel disease (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
2027$KLRAKAILERA THERAPEUTICS INCClinical data readout: HRS-7535 (KAI-7535) · Obesity (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
2027$KLRAKAILERA THERAPEUTICS INCClinical data readout: HRS-4729 (KAI-4729) (Phase 1). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$KLRAKAILERA THERAPEUTICS INCRibupatide injection: Phase 2b high-dose obesity data in 264 participants with BMI at least 35 and no type 2 diabetes. The 48-week trial evaluates 10, 13, 16 and 20 mg weekly doses; data anticipated around mid-2027. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
Supporting source
2027$KRYSKRYSTAL BIOTECH INCInterim data: KB408 · AATD Alpha-1 Antitrypsin Deficiency Lung Disease (Phase 1). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2027$KYMRKYMERA THERAPEUTICS INCIND submission: KT-200 · breast cancer and other solid tumors. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Late 2027$KYMRKYMERA THERAPEUTICS INCClinical data readout: KT-621 · Asthma (Phase 2b). Company timing: Late 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2027$LBRXLB PHARMACEUTICALS INCFDA meeting: LB-102 · SCZ Schizophrenia (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
H2 2027$LGNDLIGAND PHARMACEUTICALS INCTopline data: lasofoxifene · Metastatic breast cancer ELAINE-3 (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
H2 2027$LGNDLIGAND PHARMACEUTICALS INCTopline data: Qtorin 3.9% rapamycin anhydrous gel (Qtorin rapamycin) · Angiokeratomas (Phase 2). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-07; checked 2026-10-04.Estimated windowPrimary source
Q4 2027$LSTALisata Therapeutics, Inc.MAR002 acromegaly Phase 2 topline. ESTIMATED window: Q4 2027. 2027-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Q4 2027$LSTALisata Therapeutics, Inc.MAR001 severe hypertriglyceridemia Phase 2b topline. ESTIMATED window: Q4 2027. 2027-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
H2 2027$LTGOLatigo Biotherapeutics, Inc.LTG-321 Phase 2 topline in osteoarthritis knee pain. ESTIMATED H2 2027. December 31 is an indicative window-end marker.Estimated windowPrimary source
H2 2027$LTGOLatigo Biotherapeutics, Inc.Onzotrigine Phase 3 bunionectomy and open-label safety topline. ESTIMATED H2 2027. December 31 is an indicative window-end marker; exact day not announced.Estimated windowPrimary source
H2 2027$LXEOLexeo Therapeutics, Inc.SUNRISE-FA 2 LX2006 topline. ESTIMATED window: H2 2027. 2027-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
2027$MAZEMAZE THERAPEUTICS INCTopline data: MZE782 · PKU PKU; Phenylketonuria (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
2027$MBXMBX BIOSCIENCES INCMBX 4291: topline results from the Phase 1 obesity study are anticipated in 2027. The program studies single and multiple ascending doses of a GLP-1/GIP co-agonist prodrug; this overall readout is distinct from the first 12-week cohort update in Q4 2026. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-12; checked 2026-10-04.Estimated windowPrimary source
Trial registry
Mid-2027 (approximate)$MESOMESOBLAST LTDTopline data: rexlemestrocel-l · chronic low back pain (CLBP) (Phase 3). Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-27; checked 2026-10-04.Estimated windowPrimary source
2027$MESOMESOBLAST LTDNDA/BLA submission: rexlemestrocel-l · Chronic low back pain (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-04-29; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$MGTXMEIRAGTX HOLDINGS PLCNDA/BLA submission: AAV2-hAQP1 · Radiation-induced xerostomia (pivotal). Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
2027$MIRMMIRUM PHARMACEUTICALS INCTopline data: MRM-3379 · Fragile X syndrome BLOOM (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2027$MIRMMIRUM PHARMACEUTICALS INCTopline data: brelovitug · HDV Chronic hepatitis delta virus infection AZURE-2 AZURE-3 (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-28; checked 2026-10-04.Estimated windowPrimary source
H2 2027$MIRMMIRUM PHARMACEUTICALS INCPotential US regulatory approval of brelovitug after the planned H1 2027 BLA submission, subject to FDA review. The September 28 update targets a potential US commercial launch in Q4 2027 if approved. Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-28; checked 2026-10-04.Estimated windowPrimary source
Late 2027$MNKDMANNKIND CORPClinical data readout: insulin human (Afrezza) · T1D newly-diagnosed type 1 diabetes. Company timing: Late 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-28; checked 2026-10-04.Estimated windowPrimary source
2027$NKTRNEKTAR THERAPEUTICSInitial data: rezpegaldesleukin · T1D Type 1 diabetes mellitus (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
2027$NUVBNUVATION BIO INCClinical data readout: safusidenib · grade 3 IDH1 -mutant oligodendroglioma. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-04; checked 2026-10-04.Estimated windowPrimary source
2027$OGNORGANON & CORegulatory decision: Nexplanon. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-31; checked 2026-10-04.Estimated windowPrimary source
H2 2027$PCVXVAXCYTE INCTopline data: VAX-A1 · Disease caused by Group A Streptococcus (Phase 1). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
2027$PODDINSULET CORP510(k) submission: fully closed-loop automated insulin delivery (AID) system · T2D Type 2 diabetes EVOLVE (pivotal). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
2027$PRAXPRAXIS PRECISION MEDICINES INCTopline data: elsunersen · SCN2A DEE EMBRAVE3. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$PRAXPRAXIS PRECISION MEDICINES INCNDA/BLA submission: vormatrigine · FOS POWER1 POWER2 (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-19; checked 2026-10-04.Estimated windowPrimary source
2027$PRAXPRAXIS PRECISION MEDICINES INCNDA/BLA submission: relutrigine · SCN2A and SCN8A DEEs EMERALD. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-19; checked 2026-10-04.Estimated windowPrimary source
2027$PRAXPRAXIS PRECISION MEDICINES INCTopline data: vormatrigine · FOS (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-19; checked 2026-10-04.Estimated windowPrimary source
H2 2027$PVLAPALVELLA THERAPEUTICS INCTopline data: sirolimus (QTORIN rapamycin) · Clinically significant angiokeratomas LOTU (Phase 2). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2027$RAPPRAPPORT THERAPEUTICS INCInitial data: RAP-219. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$RCUSARCUS BIOSCIENCES INCAB102 proof-of-concept study milestone in chronic spontaneous urticaria. The quoted source forecasts the study, not a dated release of initial results. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
H2 2027$REPLREPLIMUNE GROUP INCRP1 (vusolimogene oderparepvec) plus nivolumab: interim overall-survival analysis from the randomized Phase 3 IGNYTE-3 trial in advanced melanoma is planned for H2 2027. This is distinct from the primary overall-survival readout expected in 2030; no exact day is announced. Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-03; checked 2026-10-04.Estimated windowPrimary source
H2 2027$RXRXRECURSION PHARMACEUTICALS INCInterim data: REC-4539 (Phase 1). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-06; checked 2026-10-04.Estimated windowPrimary source
H2 2027$SABSSAB Biotherapeutics, Inc.SAFEGUARD SAB-142 Phase 2b topline. ESTIMATED window: H2 2027. 2027-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
H2 2027$SCYXSCYNEXIS, Inc.SCY-770 Phase 2 early efficacy data. ESTIMATED window: H2 2027. 2027-12-31 is an indicative date within or at the end of that window, not a company-announced event day.Estimated windowPrimary source
Supporting source
2027$SNDXSYNDAX PHARMACEUTICALS INCIND submission: SNDX-62122 · Myelofibrosis. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2027$SNDXSYNDAX PHARMACEUTICALS INCInitial data: Revuforj (revumenib) · Myelofibrosis; MF (Phase 1/2). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Late 2027$STOKSTOKE THERAPEUTICS INCConditional US commercial launch target for zorevunersen, dependent on regulatory submission and approval. It is not an NDA filing deadline. Company timing: Late 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$SUPNSUPERNUS PHARMACEUTICALS INCPotential FDA authorization of a second supplier for ONAPGO. This concerns manufacturing supply for an already approved treatment, not initial marketing approval. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
2027$SYRESPYRE THERAPEUTICS INCTopline data: SPY001, SPY002, SPY003, SPY120, SPY130, SPY230 · UC Ulcerative colitis (Phase 2). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
2027$TARSTARSUS PHARMACEUTICALS INCRegulatory decision: XDEMVY (lotilaner ophthalmic solution) · Demodex blepharitis. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-23; checked 2026-10-04.Estimated windowPrimary source
H2 2027$TRVITREVI THERAPEUTICS INCTopline data: Haduvio (oral nalbuphine ER) · IPF Idiopathic pulmonary fibrosis-related chronic cough OCEAN-2 (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
H2 2027$TRVITREVI THERAPEUTICS INCTopline data: Haduvio (oral nalbuphine ER) · Refractory chronic cough; IPF-related chronic cough; non-IPF ILD-related chronic cough (Phase 2b). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$TVTXTRAVERE THERAPEUTICS INCConference presentation: FILSPARI (sparsentan) · recurrent IgAN or FSGS. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2027$TVTXTRAVERE THERAPEUTICS INCTopline data: pegtibatinase · classical Homocystinuria (HCU) (Phase 3). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2027$TYRATYRA BIOSCIENCES INCInitial data: oral dabogratinib · FGFR3-altered LG-UTUC; Low-grade upper tract urothelial carcinoma (Phase 2a/b). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2027$URGNUROGEN PHARMA LTDRegulatory decision: UGN-103 · NMIBC Recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-02; checked 2026-10-04.Estimated windowPrimary source
Mid-2027 (approximate)$VCREVICORE PHARMA HOLDING ABTopline data: buloxibutid · IPF. Company timing: Mid-2027 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-21; checked 2026-10-04.Estimated windowPrimary source
Supporting source
2027$VERAVERA THERAPEUTICS INCRegulatory decision: atacicept · IgAN IgA nephropathy (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-15; checked 2026-10-04.Estimated windowPrimary source
2027$XENEXENON PHARMACEUTICALS INCInitial data: NBI-921355 · Certain types of epilepsy (Phase 1). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-07; checked 2026-10-04.Estimated windowPrimary source
H2 2027$XNCRXENCOR INCTopline data: XmAb942 (Xtend TL1A) · UC Ulcerative colitis (Phase 2b). Company timing: H2 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
2027$XNCRXENCOR INCPhase 1 combination dose escalation of XmAb541 and XmAb808 is expected to reach its target dose range in 2027. No dated interim-data disclosure is specified. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-05; checked 2026-10-04.Estimated windowPrimary source
2027$ZBIOZENAS BIOPHARMA INCZB022: Phase 1 initiation for the oral, brain-penetrant TYK2-JH2 inhibitor is expected in 2027, subject to IND-enabling study results and regulatory clearance. This replaces the earlier 2026 plan. Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
2027$ZLABZAI LAB LTDTopline data: elegrobart · TED Thyroid eye disease (Phase 3). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$ZLABZAI LAB LTDIND submission: ZL-1222 (PD-1 / IL-12) (Phase 1). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2027$ZYMEZYMEWORKS INCIND submission: ZW1528 · COPD Chronic obstructive pulmonary disease (Phase 1). Company timing: 2027. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Approximately November 2027-January 2028 (18-20 months from May 11, 2026)$HROWHARROW INCFDA filing planned for the TRIESENCE prefilled-syringe format within 18-20 months of the May 11, 2026 update. This corresponds approximately to November 2027-January 2028 and is separate from the cataract-surgery/pain clinical study. Company timing: Approximately November 2027-January 2028 (18-20 months from May 11, 2026). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-11; checked 2026-10-04.Estimated windowPrimary source
Q1 2028$LBRXLB PHARMACEUTICALS INCTopline data: LB-102 · Bipolar depression ILLUMINATE-1 (Phase 2). Company timing: Q1 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
Q1 2028$OCULOCULAR THERAPEUTIX INCTopline data: AXPAXLI · nAMD wet AMD SOL-R (Phase 3). Company timing: Q1 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-03; checked 2026-10-04.Estimated windowPrimary source
Early 2028$PALIPalisade Bio, Inc.ASCENTRA-CD Crohn's Phase 2 primary efficacy readout. ESTIMATED window: early 2028. 2028-03-31 is an indicative date within or at the end of that window, not a company-announced event day. Early 2028 is represented operationally as January-March, not an announced exact quarter.Estimated windowPrimary source
H1 2028$HROWHARROW INCG-MELT: potential FDA approval in H1 2028 under the company development plan, following the intended H1 2027 NDA submission. This is a conditional forecast, not an assigned PDUFA deadline; potential launch is a separate H2 2028 milestone. Company timing: H1 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-06; checked 2026-10-04.Estimated windowPrimary source
Early 2028$SNDXSYNDAX PHARMACEUTICALS INCTopline data: axatilimab · GVHD Chronic graft-versus-host disease (Phase 3). Company timing: Early 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
Late 2027 / early 2028$SYRESPYRE THERAPEUTICS INCClinical data readout: SPY072 + IL-17A/F · HS. Company timing: Late 2027 / early 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
H1 2028$TRVITREVI THERAPEUTICS INCTopline data: Haduvio (oral nalbuphine ER) · IPF Idiopathic pulmonary fibrosis-related chronic cough OCEAN-1 (Phase 3). Company timing: H1 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Late 2027 / early 2028$ZYMEZYMEWORKS INCTopline data: EmpowHER-303 HER-303. Company timing: Late 2027 / early 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2028$ANABANAPTYSBIO INCTopline data: Jemperli (dostarlimab) · CRC Colorectal cancer and dMMR pan tumors (Phase 3). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-03-03; checked 2026-10-04.Estimated windowPrimary source
Late 2028$CELCCELCUITY INCTopline data: REVTORPYK (gedatolisib) · endocrine-resistant HR+/HER2- ABC (Phase 3). Company timing: Late 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
H2 2028$DNTHDIANTHUS THERAPEUTICS INCTopline data: claseprubart · gMG Generalized myasthenia gravis EMERGE (Phase 3). Company timing: H2 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
H2 2028$GPCRSTRUCTURE THERAPEUTICS INCTopline data: aleniglipron · Chronic weight management ACCOMPLISH-1 ACCOMPLISH-2 (Phase 3). Company timing: H2 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-08; checked 2026-10-04.Estimated windowPrimary source
2028$HCMHUTCHMED (CHINA) LTDInitial data: IMG-007 · Alopecia areata (Phase II). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-07-30; checked 2026-10-04.Estimated windowPrimary source
2028$HRMYHARMONY BIOSCIENCES HOLDINGS INCPotential regulatory decision (company forecast): WAKIX (pitolisant) (Phase 3). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2028$HRMYHARMONY BIOSCIENCES HOLDINGS INCPotential regulatory decision (company forecast): Pitolisant HD · Narcolepsy. Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2028$HRMYHARMONY BIOSCIENCES HOLDINGS INCPotential regulatory decision (company forecast): EPX-100 (clemizole hydrochloride) · DS Dravet Syndrome and Lennox-Gastaut Syndrome; rare epilepsies (Phase 3). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-04; checked 2026-10-04.Estimated windowPrimary source
2028$IMVTIMMUNOVANT INCTopline data: imeroprubart (IMVT-1402) · Sjögren's disease (potentially registrational). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2028$IMVTIMMUNOVANT INCTopline data: imeroprubart (IMVT-1402) · CIDP Chronic inflammatory demyelinating polyneuropathy (potentially registrational). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Trial registry
2028$KLRAKAILERA THERAPEUTICS INCClinical data readout: ribupatide injection (KAI-9531) · Obesity (Phase 3). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-12; checked 2026-10-04.Estimated windowPrimary source
2028$LGNDLIGAND PHARMACEUTICALS INCClinical data readout: Qarziba · Neuroblastoma BEACON-2. Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-02-27; checked 2026-10-04.Estimated windowPrimary source
Mid-2028 (approximate)$NKTRNEKTAR THERAPEUTICSClinical data readout: rezpegaldesleukin (Phase 3). Company timing: Mid-2028 (approximate). Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
2028$TARSTARSUS PHARMACEUTICALS INCTopline data: aqueous chlorine dioxide solution (IRX-101) COMFORT (Phase 3). Company timing: 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
Late 2028$XERSXERIS BIOPHARMA HOLDINGS INCXP-8121: topline results from the Cornerstone Phase 3 program in hypothyroidism are forecast for late 2028. This is a company development projection. Company timing: Late 2028. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-09; checked 2026-10-04.Estimated windowPrimary source
Early 2029$ATAIATAIBECKLEY INCTopline data: BPL-003 (Phase 3). Company timing: Early 2029. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-12; checked 2026-10-04.Estimated windowPrimary source
H1 2029$LBRXLB PHARMACEUTICALS INCTopline data: LB-102 · adjunctive treatment of MDD (Phase 2). Company timing: H1 2029. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-11; checked 2026-10-04.Estimated windowPrimary source
2029$NKTRNEKTAR THERAPEUTICSTarget for the first rezpegaldesleukin BLA submission. This is company development guidance, not a scheduled FDA approval decision. Company timing: 2029. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
2029$NUVBNUVATION BIO INCClinical data readout: safusidenib · IDH1 -mutant astrocytoma (pivotal Phase 3). Company timing: 2029. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-05-04; checked 2026-10-04.Estimated windowPrimary source
H2 2029$TARSTARSUS PHARMACEUTICALS INCTopline data: gildeuretinol (ALK-001) · Stargardt disease (Phase 3). Company timing: H2 2029. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-06; checked 2026-10-04.Estimated windowPrimary source
2030$CELCCELCUITY INCTopline data: REVTORPYK (gedatolisib) · endocrine-sensitive HR+/HER2- ABC (Phase 3). Company timing: 2030. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-13; checked 2026-10-04.Estimated windowPrimary source
2030$REPLREPLIMUNE GROUP INCRP1 (vusolimogene oderparepvec) plus nivolumab: primary overall-survival readout from Phase 3 IGNYTE-3 is expected in 2030. The trial compares the combination with physician's choice in advanced melanoma after anti-PD-1 and anti-CTLA-4 therapies or when anti-CTLA-4 is unsuitable. The H2 2027 interim OS analysis is a separate milestone. Company timing: 2030. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-08-14; checked 2026-10-04.Estimated windowPrimary source
2030$XERSXERIS BIOPHARMA HOLDINGS INCXP-8121: potential FDA approval and commercial launch in 2030 are long-range company projections, conditional on trial outcomes and regulatory review; no assigned PDUFA date. Company timing: 2030. Exact event day is not announced. CSV Date is a conventional window-end marker, not an announced event day. Primary source dated 2026-09-09; checked 2026-10-04.Estimated windowPrimary source
Supporting source

Recent history: 35 events

The following rows record completed events and dates that have passed. A past date does not prove an outcome or that a scheduled presentation occurred; uncertain status is stated in each row.

Date / windowTickerCompanyEventStatusSources
Aug 12, 2026 — announcement$ALTAltimmune, Inc.RESTORE Phase 2 enrollment completed in July 2026; announcement August 12Exact July completion day not disclosed. This row uses the announcement date; the H2 2027 topline is a separate future milestone.HISTORICAL · Completed eventPrimary source
Sep 21, 2026$NAMSNewAmsterdam PharmaUbeslo / Evlarco: European Commission authorizationEU authorization announced September 21; the former September 28 estimated marker is resolved.HISTORICAL · Completed eventPrimary source
$GRALGRAILGalleri — multi-cancer early detection test for adults aged 50 and overOn September 23, the advisory panel voted 7–2 with one abstention that benefits outweigh risks; safety 10–0; effectiveness 6–4, according to GRAIL. The vote is nonbinding. FDA review of the Galleri PMA continues; this is not approval.HISTORICAL · FAVORABLE ADCOM — FDA PENDINGGRAIL · FDA
Sep 23, 2026$ARCTArcturus TherapeuticsARCT-810 Phase 2 interim results and LUNAR 2.0 update releasedSeptember 23 release and webcast resolve the former September 30 estimated marker. ARCT-2601 integration is a separate future milestone.HISTORICAL · Completed eventPrimary source
2026-09-24$MRKMerck & Co.Belzutifan plus lenvatinib FDA-approved September 24; former October 4 target resolved.HISTORICAL · FDA approvedPrimary source
$MIRMMirum PharmaceuticalsAtebrioz (zilurgisertib)FDA lists approval on September 25, 2026 for reducing new heterotopic ossification in adults and patients aged 12 and older with FOP. Former September 26 PDUFA target resolved; licensed from Incyte.HISTORICAL · FDA APPROVEDFDA
2026-09-25$MRKMerck & Co.Ifinatamab deruxtecan BLA voluntarily withdrawn September 25; former October 10 target superseded. Phase 3 continues.HISTORICAL · Application withdrawnPrimary source
2026-09-28$KODKodiak SciencesDAYBREAK: Zenkuda and KSI-501 met vision non-inferiority primary endpoints versus aflibercept; sponsor topline September 28. Zenkuda 54% at 24-week dosing. Not FDA approval.HISTORICAL · Results publishedPrimary source
Sep 24, 2026$KYTXKyverna Therapeutics, Inc.Phase 2 longer-term miv-cel follow-up in generalized myasthenia gravis released September 24, 2026. The former Q3 window is resolved.HISTORICAL · Results releasedPrimary source
Sep 24, 2026$KYTXKyverna Therapeutics, Inc.One-year miv-cel topline in stiff person syndrome released September 24, 2026. The former Q3 window is resolved.HISTORICAL · Results releasedPrimary source
Sep 24, 2026$ACADAcadia Pharmaceuticals Inc.Phase 2 remlifanserin topline released September 24, 2026. Primary endpoint missed statistical significance (p=0.0603); Phase 3 continuation planned with protocol amendments.HISTORICAL · Results releasedPrimary source
2026-09-28$ACETAdicet Bio, Inc.Prula-cel Phase 1 clinical data released in SLE/LN.HISTORICAL — Results releasedPrimary source
2026-09-28$MIRMMirum PharmaceuticalsAZURE-1 Phase 3 brelovitug topline released; primary endpoint met.HISTORICAL — Results releasedPrimary source
2026-09-29$IVVDInvivyd, Inc.LIBERTY Phase 3 VYD2311 safety/tolerability topline released; distinct DECLARATION study remains pending.HISTORICAL — Results releasedPrimary source
Q3 2026$IVVDInvivyd, Inc.Prior combined LIBERTY/DECLARATION forecast superseded by separate company updates on 29 September.HISTORICAL — Superseded forecastPrimary source
2026-09-28$IVAInventiva S.A.First-half 2026 financial results published; 08:00 ET call announced, occurrence not separately verified.HISTORICAL — Results releasedPrimary source
2026-09-28$IMMPImmutep LimitedAnnounced ADS-ratio change; market execution not independently verified.HISTORICAL — Execution unverifiedPrimary source
2026-09-28$SABSSAB BiotherapeuticsSAB-142 Phase 1 presentation scheduled at EASD; occurrence not independently verified.HISTORICAL — Occurrence unverifiedPrimary source
2026-09-29$KYTXKyverna TherapeuticsKYSA-6 Phase 2 follow-up presentation scheduled at AANEM; occurrence not independently verified.HISTORICAL — Occurrence unverifiedPrimary source
$SRPTSarepta TherapeuticsWMS Duchenne data presentationsScheduled scientific presentation, not an automatic pivotal readout. Stock HubHISTORICAL — Occurrence unverifiedPrimary source
Sep 30, 2026$INCYIncyte CorporationSTOP-HS Phase 3 povorcitinib posters at EADV 2026. Incyte lists two povorcitinib STOP-HS1/STOP-HS2 Phase 3 poster abstracts for the EADV 2026 session on 30 September 2026 at 07:00 CEST, covering acne and high-disease-burden analyses. This is a congress presentation of additional analyses, not a new topline readoutHISTORICAL — Occurrence unverifiedPrimary source
Sep 30, 2026$INCYIncyte CorporationTRuE-AD4 ruxolitinib cream poster at EADV 2026. Incyte lists the TRuE-AD4 poster on ruxolitinib cream in moderate atopic dermatitis for the EADV 2026 session on 30 September 2026 at 07:00 CEST. This is a congress presentation, not a new pivotal topline readoutHISTORICAL — Occurrence unverifiedPrimary source
Sep 30, 2026$SABSSAB Biotherapeutics, Inc.three SAB-142 Phase 1 presentations at EASD 2026HISTORICAL — Occurrence unverifiedPrimary source
Oct 1, 2026 · 16:30 CEST$NKTRNektar TherapeuticsREZOLVE-AA Phase 2b 52-week rezpegaldesleukin data oral presentation at EADVPresentation 16:30-16:40 CEST, Hall N, abstract AS-1872; conference discussion of previously reported data.HISTORICAL — Results releasedPrimary source
Oct 1, 2026 · 10:25 CEST$NKTRNektar TherapeuticsREZOLVE-AD Phase 2b maintenance rezpegaldesleukin data oral presentation at EADVPresentation 10:25-10:35 CEST, Hall N, abstract AS-1732; distinct from initial topline.HISTORICAL — Results releasedPrimary source
Oct 1, 2026 · session 16:30–18:00 CEST$ARTVArtiva Biotherapeutics, Inc.AlloNK (AB-101) plus rituximab Sjogren disease clinical data presentation at ISSjDConfirmed presentation day. Session 16:30-18:00 CEST; individual talk time unspecified. Data from 11 patients; not a Phase 3 RA readout.HISTORICAL — Results released; oral session unverifiedPrimary source
Oct 1, 2026 · 16:30 CEST$EVMNEvommune, Inc.EVO301 Phase 2a atopic dermatitis late-breaking data presentation at EADV16:30-16:45 CEST, Hall A. Topline was already released in February; this is a conference presentation.HISTORICAL — Occurrence unverifiedPrimary source
Oct 2, 2026$SANASana Biotechnology, Inc.UP421 clinical-data symposium at EASD 2026Presentation day confirmed; no presentation time inferred.HISTORICAL — Occurrence unverifiedPrimary source
$TRDAEntrada TherapeuticsENTR-601-44 pharmacokinetic / pharmacodynamic translation presentation at WMSScientific presentation; not assumed to be a new patient efficacy readout. Stock HubHISTORICAL — Occurrence unverifiedPrimary source
Sep 27–30, 2026 (conference)$BIAFbioAffinity Technologies, Inc.CyPath Lung posters at NAVREF 2026The individual poster presentation days have not been announced.HISTORICAL — Occurrence unverifiedPrimary source
Q3 2026$QUREuniQure N.V.AMT-130 four-year Phase 1/2 analysis in Huntington's diseaseSeptember 30 is an indicative end-of-window marker. No four-year analysis release was found through September 27.HISTORICAL — Estimate expired; outcome unverifiedPrimary source
Q3 2026$CRMDCorMedix TherapeuticsREZZAYO prophylaxis sNDA submissionCompany-guided submission window; submission not yet confirmed in the sources reviewed.HISTORICAL — Estimate expired; outcome unverifiedPrimary source
End of September 2026$MLTXMoonLake ImmunotherapeuticsSonelokimab BLA submission in adult and adolescent hidradenitis suppurativaSeptember 30 is an indicative window-end marker. No filing-completed release was found through September 27.HISTORICAL — Estimate expired; outcome unverifiedPrimary source 1 · Primary source 2
Sep 30, 2026$BMYBristol Myers SquibbCAMZYOS (mavacamten): FDA approved pediatric oHCM expansion for patients weighing at least 30 kg.HISTORICAL — FDA approvedPrimary source
September 29 to October 3, 2026$CAPRCapricor Therapeutics, Inc.Deramiocel HOPE-3 and HOPE-3 OLE presentations at WMS 2026September 29 is conference-start marker, not a verified readout day. HOPE-3 oral presentation is confirmed October 3. Late-breaking HOPE-3 OLE poster day is not specified by this release. Conference in Hiroshima, Japan.Conference rangePrimary source

The Tracker shows a curated feed of upcoming catalysts and open windows; the Calendar also retains history. The AI Lookup searches the web for current information on the complete ticker universe, including tickers with only historical events. ClinicalTrials.gov data-collection dates are not results-publication dates. Windows and deadlines can change. Educational information only; not financial advice.

Full calendar

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Below: clinical and corporate events with a confirmed day, conferences, company windows and recent history, every entry with its primary source, plus the full event calendar, the Catalyst Lookup and the glossary.

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The free Biotech Catalyst Calendar combines an embedded archive with a sourced selection of regulatory deadlines, clinical readouts, congress presentations and company milestones. Exact dates and estimated windows are labeled separately; completed events remain in history.

The page also includes a glossary covering key FDA, clinical trial, and catalyst terminology, including regulatory designations, trial progress stages, and common clinical metrics. All data is sourced from public information and may contain errors or estimated dates; users are advised to verify with official sources before making any decisions.

Biotech Catalyst Lookup

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Dates, events and sources may be incomplete, incorrect or out of date. Check the information against official company releases, SEC filings, FDA documents or ClinicalTrials.gov. Estimated dates are not firm deadlines.

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Catalyst Calendar Glossary

Quick definitions for FDA, clinical-trial, and “catalyst” terms used in the calendar & trackers.

1) FDA / Regulatory

Term Meaning
PDUFA dateFDA target action date for an NDA/BLA decision (often disclosed via filings/press releases).
Priority ReviewFDA review goal generally 6 months; the clock depends on the application type. It does not guarantee approval or a decision on a fixed date.
Standard ReviewFDA review goal generally 10 months; clock start and pathway depend on the application.
AdComAdvisory committee: reviews evidence and may vote; a meeting does not imply approval and its advice is not binding on FDA.
NDA / BLAApplications to approve a drug (NDA) or a biologic (BLA).
sNDA / sBLASupplemental application (label expansion, new population, new formulation, etc.).
Filing acceptanceFDA accepts the application as sufficiently complete to start review (often when PDUFA is set).
RTF (Refuse-to-File)FDA declines to accept an application for review (formal/technical deficiencies).
CRL (Complete Response Letter)FDA does not approve at that time and requests additional info/changes before resubmission.
Resubmission (Class 1 / Class 2)Re-file after CRL; Class 1 = minor changes (often shorter), Class 2 = major (often longer).
PDUFA delay/extensionFDA pushes the action date (more time needed for review, inspections, analyses, etc.).

2) FDA Meetings

TermMeaning
Type AUrgent/critical meeting (clinical hold, disputes, time-sensitive issues).
Type BStandard “milestone” meeting (End-of-Phase, pre-NDA/BLA, etc.).
Type COther focused meeting on specific topics; can still be strategically important.
EOP (End-of-Phase)Aligns requirements to move forward (next phase / registrational plan / filing path).
SPASpecial Protocol Assessment: FDA agrees in advance on design/endpoint of a key trial (not a guarantee).

3) Trial Progress vs Data Release

Term Meaning Data released?
Enrollment InitiationFirst sites/patients start enrolling.NO
Enrollment CompleteEnrollment finished (no more new patients).NO
Trial CompletedFinal protocol-defined data collection completed. Primary completion concerns primary outcomes; study completion includes secondary outcomes and adverse events. Neither means results have been published.NO
Database LockDataset is finalized for analysis (internal milestone).NO
Interim DataResults from an interim analysis, which may remain internal. They count as released data only when publicly disclosed.IF DISCLOSED
Topline DataHigh-level results release (often via PR/filing).YES
Data Released / ReadoutResults publicly disclosed; internal analysis alone does not constitute a public readout.YES
Full Results / Full DatasetDetailed results published or presented; does not necessarily mean access to the full raw dataset.YES
Conference PresentationAbstract, poster or oral presentation. A scheduled slot alone does not establish that new results have been released.IF DISCLOSED
PublicationPeer-reviewed paper / full write-up.YES
Key rule: “Trial Completed” ≠ “Data Released”. Completion is an operational milestone; data can come weeks/months later.

4) Common Clinical Metrics

TermMeaning
OSOverall Survival.
PFSProgression-Free Survival.
ORRObjective Response Rate (CR + PR).
CR / PRComplete / Partial Response.
SD / PDStable Disease / Progressive Disease.
DORDuration of Response.
AE / SAEAdverse event / serious adverse event under regulatory criteria, such as death, life-threatening events or hospitalization. Seriousness differs from severity of intensity; causation is not automatic.
PK / PDPharmacokinetics / Pharmacodynamics.
BiomarkerBiological marker used for selection/response/target engagement.

5) “Accelerators” / Designations

TermMeaning
ODDOrphan Drug Designation (rare-disease incentives).
FTDFast Track Designation (more frequent interactions; potential rolling submission).
BTDBreakthrough Therapy Designation: preliminary clinical evidence of potential substantial improvement on clinically significant endpoints over available therapies for a serious condition. It is not approval.
RMATDesignation for eligible regenerative therapies, including certain cell, tissue and gene therapies, with preliminary clinical evidence of potential to address unmet needs in serious conditions. It is not approval.
RPDD / PRVRPDD is a rare pediatric disease designation. A PRV is a separate voucher that may be awarded with a qualifying approval and transferred or used to request priority review of another application. Designation guarantees neither a voucher nor approval.

6) Calendar Fields (how to read them)

FieldMeaning
StageProgram phase (Preclinical, Phase 1/2/3, NDA/BLA Filing, PDUFA, etc.).
StatusOperational status (Ongoing, Trial Completed, Data Released, Clinical Hold, etc.).
Next catalystNext expected milestone (Topline, Interim, Conference, Submission, Regulatory Decision).
Catalyst dateDate or time window (exact / month / quarter / half / year / range).

Glossary sources: FDA BTD · FDA RMAT · FDA RPDD/PRV · FDA SAE · ClinicalTrials.gov

Related research

Methodology

Stock Hub follow-up, September 27, 2026: 18 missing events added for CGEM, TRDA, SRPT, ORKA and PRAX, checked against sponsor or SEC disclosures. Existing relutrigine and EVERLAST entries were preserved. Scheduled scientific presentations are distinguished from new efficacy readouts; company windows remain estimates. This targeted addition does not re-verify unrelated archive entries.

Sources: FDA documents, SEC filings, sponsor releases and ClinicalTrials.gov. The September 27, 2026 review integrates 49 new or recovered future milestones, updates ACET, ACIU, XENE and CAPR, and separates completed events into history. Other entries retain earlier September 19–26 checks; this update does not re-certify every archive entry. The embedded calendar may include historical events and estimated windows. Registry dates concern data collection, not necessarily public readouts. Stated times include their timezone; EDT is New York daylight time and CEST is daylight time in Italy.

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Important Disclaimer

The dates and events shown in this calendar are collected from publicly available sources and company communications, but may change at any time and may contain errors, inaccuracies, delays or omissions. Some dates are estimated, some timelines may be revised, and certain catalysts may be postponed, cancelled or updated without notice. Always verify with official press releases, SEC filings and primary company sources before making any trading or investment decision.

This content is for educational and informational purposes only. It is not investment advice and not a recommendation to buy or sell any security. Do your own research and consult a licensed advisor. Full disclaimer: merlintrader.com/disclaimer.