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Biotech catalyst, news and analysis PDUFA tracker
Biotech catalyst, news and analysis PDUFA tracker
FDA decisions, PDUFA dates, advisory committees and clinical-trial readouts for publicly traded biotech stocks.
Tables updated: October 3, 2026; glossary reviewed: September 19, 2026This 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.
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.
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| $RHHBY | Roche | Tecentriq (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) statusPriority 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. | PDUFA (sBLA) | Source | |
| $RHHBY | Roche | Enspryng (satralizumab) — moderate-to-severe thyroid eye diseasePriority Review based on SatraGO-1 and SatraGO-2. SatraGO-2 met its primary endpoint; SatraGO-1 did not reach statistical significance. | PDUFA (sBLA) | Source | |
| $IRD / $VTRS | Opus Genetics / Viatris | MR-141, phentolamine ophthalmic solution 0.75% — presbyopiaOne sNDA shared by both partners, counted once. | PDUFA (sNDA) | Source · Source | |
| $IONS | Ionis Pharmaceuticals | bepirovirsen, developed with GSK — chronic hepatitis B | PDUFA | Source | |
| $INO | Inovio Pharmaceuticals | INO-3107, DNA immunotherapy — recurrent respiratory papillomatosis in adults | PDUFA (BLA) | Source | |
| $AGIO | Agios Pharmaceuticals | Pyrukynd (mitapivat) — sickle cell disease, accelerated approval pathway | PDUFA (sNDA) | Source | |
| $BTAI | BioXcel Therapeutics | Igalmi (dexmedetomidine, sublingual film) — acute agitation in bipolar disorder or schizophrenia, at-home use | PDUFA (sNDA) | Source | |
| $CYTK | Cytokinetics | aficamten — obstructive hypertrophic cardiomyopathy, extension based on the MAPLE-HCM trial | PDUFA (sNDA) | Source | |
| $SMMT | Summit Therapeutics | ivonescimab (SMT112) — EGFR-mutated non-squamous NSCLC, after TKI, in combination with chemotherapy | PDUFA | Source | |
| $CAPR | Capricor Therapeutics | Deramiocel (CAP-1002), cell therapy for Duchenne muscular dystrophy; refined proposed indication focused on upper limb functionOn August 24, 2026 Capricor announced a PDUFA extension from August 22 to November 22 after a major amendment including 24-month HOPE-3 OLE data. Review remains pending. | PDUFA | Primary source | |
| $SVRA | Savara | Molbreevi (molgramostim), inhalation solution — autoimmune pulmonary alveolar proteinosisdate extended by three months for a major amendment | PDUFA | Source | |
| $SNY | Sanofi | venglustat, oral glucosylceramide synthase inhibitor — Gaucher disease type 3, neurological manifestations | PDUFA | Source | |
| $BBIO | BridgeBio Pharma | BBP-418 — limb-girdle muscular dystrophy LGMD2I/R9 | PDUFA | Source | |
| $GSK | GSK | neladalkib (NVL-655) — advanced ALK-positive NSCLC, previously treated with TKIformerly a Nuvalent asset, acquired by GSK on 15 July 2026 | PDUFA | GSK — FDA date · Acquisition | |
| $PYPD | PolyPid | D-PLEX100, local prolonged-release doxycycline depot — prevention of surgical site infections in colorectal surgery | PDUFA | Source | |
| $COGT | Cogent Biosciences | bezuclastinib, with sunitinib — gastrointestinal stromal tumours previously treated with imatinib | PDUFA | Source | |
| $RHHBY | Roche | giredestrant — adjuvant treatment of ER-positive, HER2-negative early breast cancer, lidERA trial | PDUFA | Source | |
| $VRTX | Vertex Pharmaceuticals | povetacicept, dual BAFF and APRIL inhibitor — IgA nephropathy, accelerated approval pathway | PDUFA | Source | |
| $VNDA | Vanda Pharmaceuticals | imsidolimab, IL-36R antagonist — generalized pustular psoriasismolecule originated by AnaptysBio, BLA held by Vanda | PDUFA | Source | |
| $CORT | Corcept Therapeutics | relacorilant, selective glucocorticoid receptor antagonist — Cushing’s syndromeNDA resubmitted on 17 June 2026 after a CRL on this indication | PDUFA | Source | |
| $RHHBY | Roche | giredestrant + everolimus — ER+/HER2− advanced or metastatic breast cancer with an ESR1 mutation, following progression on or after prior endocrine therapy | PDUFA | Source | |
| Dec 18, 2026 | $CAMX | Camurus AB | CAM2029 (Oclaiz), acromegaly NDA resubmission: FDA target action dateA review target is not an approval. Nasdaq Stockholm ticker CAMX. | PDUFA | Primary source |
| $MLYS | Mineralys Therapeutics | lorundrostat — hypertension in adults, in combination with other antihypertensives | PDUFA | Mineralys Q2 | |
| $GILD | Gilead Sciences | anito-cel (anitocabtagene autoleucel), anti-BCMA CAR-T — relapsed or refractory multiple myeloma, fourth lineBLA filed by Arcellx, acquired by Gilead on 28 April 2026 | PDUFA | Source | |
| $PRAX | Praxis Precision Medicines | relutrigine — SCN2A and SCN8A developmental and epileptic encephalopathiesdate extended from 27 September 2026 for a major amendment | PDUFA | Source | |
| $VTRS | Viatris | fast-acting meloxicam — moderate to severe acute pain, non-opioid analgesic | PDUFA | Viatris Q2 | |
| $COGT | Cogent Biosciences | bezuclastinib monotherapy — non-advanced systemic mastocytosis | PDUFA | Source | |
| $PRAX | Praxis Precision Medicines | Ulixacaltamide — FDA PDUFA target action date, essential tremorTarget action date; approval is not assured. Stock Hub | PDUFA | Primary source | |
| $CGEM | Cullinan Therapeutics | Zipalertinib FDA target action: post-platinum EGFR exon 20 insertion NSCLCTarget action date; approval is not assured. Stock Hub | PDUFA | Primary source | |
| $SRPT | Sarepta Therapeutics | AMONDYS 45 / VYONDYS 53 FDA sNDA action targetTarget action date; approval is not assured. Stock Hub | PDUFA | Primary source | |
| $EXEL | Exelixis | zanzalintinib + atezolizumab — previously treated metastatic colorectal cancer, STELLAR-303New 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. | PDUFA — extended | SEC 8-K | |
| 2027-06-29 | $COGT | Cogent Biosciences | Bezuclastinib 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. | PDUFA | Primary source |
| Date / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| 2026-10-05 | $BLFS | BioLife Solutions / Repligen | BioLife shareholder vote on Repligen merger, 09:00 ET / 15:00 Europe/Rome. Closing remains conditional. | Announced date | Primary source |
| 2026-10-08 | $BBIO | BridgeBio Pharma | Commercial 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. | Announced date | Primary source |
| 2026-10-20 | $ANAB | AnaptysBio | Post-trial hearing in GSK/Tesaro Jemperli litigation. Hearing date is not judgment date. | Announced date | Primary source |
| Oct 24, 2026 | $CMPX | Compass Therapeutics, Inc. | COMPANION-002 tovecimig oral presentation at ESMO 2026 | Presentation | Primary source |
| 2026-10-25 | $GSK | GSK / AnaptysBio | AZUR-1 dostarlimab Phase 2 first-results presentation at ESMO, Madrid; distinct from FDA review. | Announced date | Primary source |
| 2026-10-25 | $SMMT | Summit Therapeutics / Akeso | HARMONi-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. | Announced date | Primary source |
| $CGEM | Cullinan Therapeutics | Velinotamig SLE multidose data at ACR ConvergenceEarly clinical data; not a pivotal efficacy result. Stock Hub | Confirmed presentation | Primary source | |
| Nov 9, 2026 | $ARTV | Artiva Biotherapeutics, Inc. | AlloNK + rituximab: updated Phase 2a basket data in RA, Sjögren disease and systemic sclerosis at ACR; oral session 15:00–16:30 EST. | Confirmed day | Primary source |
| Nov 10, 2026 | $ARTV | Artiva Biotherapeutics, Inc. | AlloNK + rituximab: distinct ACR poster on safety and B-cell depletion across 60 rheumatology patients. | Confirmed day | Primary source |
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 / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| September 29 to October 3, 2026 | $CAPR | Capricor 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 range | Primary source |
| Oct 21–23, 2026 (conference) | $KYTX | Kyverna Therapeutics, Inc. | KYSA-8 miv-cel full one-year dataset presentation at MS TorontoPresentation day not announced. Topline was released September 24. | Conference range | Primary source |
| Nov 16–19, 2026 (conference) | $ACAD | Acadia Pharmaceuticals Inc. | RADIANT Phase 2 remlifanserin detailed safety and efficacy oral presentation at CTADPresentation day not announced. Topline was released September 24; the primary endpoint was not statistically significant (p=0.0603). | Conference range | Primary source |
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 / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| by end of 2026 | $BCRX | BioCryst Pharmaceuticals, Inc. | BCX17725 Phase 1 Part 4 data in Netherton syndromeUp to 12 patients followed for three months; no exact release day. | Estimated window | Primary source |
| 2026 | $SANA | Sana Biotechnology, Inc. | SC451 IND filing and Phase 1/2 trial start goalCompany goal, conditional on nonclinical, manufacturing and regulatory execution. This event does not set a date for SG293 data. | Estimated window | Primary source |
| H2 2026 | $BIOA | BioAge Labs, Inc. | QUELL-CV BGE-102 Phase 2 topline in cardiovascular risk | Estimated window | Primary source 1 · Primary source 2 |
| H2 2026 | $JANX | Janux Therapeutics, Inc. | JANX011 Phase 1 initial clinical data in healthy volunteersHealthy-volunteer data, not efficacy results in autoimmune patients. | Estimated window | Primary source |
| H2 2026 | $CRSP | CRISPR Therapeutics AG | CTX310 Phase 1b severe hypertriglyceridemia cohort clinical updateDistinct from the Phase 1a one-year durability data already presented at ESC on August 28. | Estimated window | Primary source |
| later in 2026 | $GOSS | Gossamer Bio, Inc. | FDA filing-acceptance review of seralutinib NDAIssuer expects this could occur later this year. No PDUFA announced; timing is not a guaranteed Q4 appointment. | Estimated window | Primary source |
| By year-end 2026 | $ARCT | Arcturus Therapeutics Holdings Inc. | ARCT-2601 integration into the ongoing OTC-deficiency Phase 2 studyCompany plan following the September 23 ARCT-810 interim announcement; regulatory and operational execution remain prospective. | Estimated window | Primary source |
| By year-end 2026 | $TRDA | Entrada Therapeutics | ENTR-601-44 ELEVATE-44-201 cohort 1 open-label follow-up Stock Hub | Estimated window | Primary source |
| H2 2026 (remaining window) | $TRDA | Entrada Therapeutics | Vertex VX-670 GALILEO multiple-ascending-dose clinical data in DM1Partner-controlled clinical readout; registry completion is a different event. Stock Hub | Estimated window | Primary source |
| H2 2026 (remaining window) | $SRPT | Sarepta Therapeutics | SRP-1001 / SRP-1003 Phase 1/2 multiple ascending dose dataCompany guidance; exact date unannounced. Stock Hub | Estimated window | Primary source |
| Q4 2026 | $SNDX | Syndax Pharmaceuticals, Inc. | MAXPIRe axatilimab Phase 2 topline in idiopathic pulmonary fibrosis | Estimated window | Primary source 1 · Primary source 2 |
| Q4 2026 | $SNDX | Syndax Pharmaceuticals, Inc. | Axatilimab plus ruxolitinib Phase 2 topline in newly diagnosed chronic GVHD | Estimated window | Primary source 1 · Primary source 2 |
| Q4 2026 | $TCRX | TScan Therapeutics, Inc. | ALLOHA Phase 1 Cohort C updated TSC-101 clinical dataData guidance maintained despite a pause in further Phase 3 ALLOHA-2 enrollment; this is not Phase 3 topline. | Estimated window | Primary source |
| Q4 2026 | $IVA | Inventiva S.A. | NATiV3 Phase 3 lanifibranor topline in MASHLast patient visit completed; exact readout day unannounced. | Estimated window | Primary source |
| Q4 2026 | $OCUL | Ocular Therapeutix, Inc. | AXPAXLI wet AMD NDA submission with interim SOL-R safety analysisGuidance reaffirmed after completed pre-NDA meeting. Submission is neither FDA acceptance nor approval. Primary issuer release syndicated on Nasdaq. | Estimated window | Primary source |
| Q4 2026 | $CLYM | Climb Bio, Inc. | CLYM116 additional Phase 1 and Mabworks initial healthy-volunteer dataPlanned for a medical meeting in Q4; meeting and presentation date not named. December 31 is a window-end marker. | Estimated window | Primary source 1 · Primary source 2 |
| Q4 2026 | $RGNX | REGENXBIO Inc. | ATMOSPHERE and ASCENT pivotal surabgene lomparvovec topline in wet AMDDistinct from registry primary-completion markers. December 31 is not an announced release day. | Estimated window | Primary source |
| October 2026 | $TRDA | Entrada Therapeutics | ENTR-601-45 ELEVATE-45-201 cohort 1 clinical data5 mg/kg cohort; reporting month, not an announced day. Stock Hub | Estimated window | Primary source |
| Q4 2026 | $ORKA | Oruka Therapeutics | ORKA-004 planned entry into clinical developmentCompany guidance; exact date unannounced. Stock Hub | Estimated window | Primary source |
| October 2026 | $MIRM | Mirum Pharmaceuticals / Incyte | Atebrioz US commercial launch expected October 2026; exact day not announced. ESTIMATED window: October 2026. | Estimated window | Primary source |
| Q4 2026 or Q1 2027 | $ANAB | AnaptysBio / GSK | Jemperli litigation judgment anticipated Q4 2026 or Q1 2027; exact day unknown. | Estimated window | Primary source |
| Q4 2026 | $PRAX | Praxis Precision Medicines | Relutrigine 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. Stock Hub | Estimated window | Primary source |
| Q4 2026 | $KOD | Kodiak Sciences | Zenkuda 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 window | Primary source |
| Around November 1, 2026 (calculated) | $QURE | uniQure N.V. | AMT-130 BLA filing-review decision windowNovember 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. | Calculated estimate | Primary source |
| End of November 2026 | $MLTX | MoonLake Immunotherapeutics | Sonelokimab HS BLA acceptance, Priority Review decision and PDUFA date allocationConditional on planned filing; November 30 is an indicative marker, not an announced PDUFA date. | Estimated window | Primary source 1 · Primary source 2 |
| November 2026 | $RHHBY | Roche Holding AG | Gazyva/Gazyvaro (obinutuzumab): FDA decision window in primary membranous nephropathyPriority Review is confirmed, but the issuer states November, not a specific day. | Estimated window | Primary source |
| December 2026 | $CGEM | Cullinan Therapeutics | CLN-978 multidose clinical update: SLE, RA and Sjögren’sThe three indications are one concurrent data package, not three independent dates. Stock Hub | Estimated window | Primary source |
| December 2026 | $CGEM | Cullinan Therapeutics | CLN-049 updated AML clinical data Stock Hub | Estimated window | Primary source |
| December 2026 | $KOD | Kodiak Sciences | KSI-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 window | Primary source |
| Q1 2027 | $OCGN | Ocugen, Inc. | OCU400 Phase 3 liMeliGhT topline in retinitis pigmentosa | Estimated window | Primary source |
| Q1 2027 | $ATYR | aTyr Pharma, Inc. | EFZO-CONNECT efzofitimod Phase 2 topline in systemic sclerosis-related ILD | Estimated window | Primary source 1 · Primary source 2 |
| early 2027 | $NKTR | Nektar Therapeutics | Planned registrational Phase 3 rezpegaldesleukin study initiation in alopecia areataEarly 2027 is company guidance; March 31 is only a conventional marker, not a promised deadline. | Estimated window | Primary source |
| Q1 2027 | $BMEA | Biomea Fusion, Inc. | COVALENT-211 Phase 2 icovamenib Week 26 primary-endpoint topline in type 2 diabetesEnrollment completed; company readout guidance separate from registry primary completion. | Estimated window | Primary source |
| H1 2027 | $ZNTL | Zentalis Pharmaceuticals, Inc. | DENALI Part 2 integrated azenosertib topline in Cyclin E1-positive platinum-resistant ovarian cancerUpdated guidance supersedes the previous year-end 2026 expectation. | Estimated window | Primary source 1 · Primary source 2 |
| H1 2027 | $JANX | Janux Therapeutics, Inc. | JANX007 additional clinical data at a future medical congressCongress and presentation day have not been identified. | Estimated window | Primary source |
| H1 2027 | $IVA | Inventiva S.A. | Planned lanifibranor regulatory submission following NATiV3Conditional on favorable NATiV3 results; filing is not approval. | Estimated window | Primary source |
| H1 2027 | $SCTX | Scribe Therapeutics Inc. | STX-1150 Phase 1 initial single-ascending-dose clinical dataPlanned data include safety, tolerability and LDL-C lowering. June 30 is a window-end marker. | Estimated window | Primary source |
| H1 2027 | $CLYM | Climb Bio, Inc. | CLYM116 NAVIGATE-2 Phase 2 initial data in IgA nephropathyJune 30 is a window-end marker; study evaluates Q8W/Q12W dosing. | Estimated window | Primary source |
| H1 2027 | $MLTX | MoonLake Immunotherapeutics | IZAR-1 sonelokimab Phase 3 full Week 52 readout in psoriatic arthritisThe trial remains blinded through Week 52. June 30 is a conventional window-end marker. | Estimated window | Primary source |
| H1 2027 | $CRMD | CorMedix Therapeutics | REZZAYO prophylaxis: potential FDA action subject to filing acceptanceConditional company guidance, not a confirmed PDUFA date. | Estimated window | Primary source |
| Q1 2027 | $TRDA | Entrada Therapeutics | ENTR-601-44 ELEVATE-44-201 cohort 2 higher-dose data12 mg/kg cohort. Do not confuse with ENTR-601-45 cohort 2 H1 guidance. Stock Hub | Estimated window | Primary source |
| Q1 2027 | $SRPT | Sarepta Therapeutics | ENDEAVOR cohort 8 full-cohort 12-week dataCompany guidance; exact date unannounced. Stock Hub | Estimated window | Primary source |
| Q1 2027 | $ORKA | Oruka Therapeutics | ORKA-002 ORCA-SURGE Phase 2 Week 16 dataCompany guidance; exact date unannounced. Stock Hub | Estimated window | Primary source |
| H1 2027 | $ORKA | Oruka Therapeutics | ORKA-001 planned Phase 3 initiationCompany guidance; exact date unannounced. Stock Hub | Estimated window | Primary source |
| February 2027 | $GSK | GSK / AnaptysBio | Jemperli 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 window | Primary source |
| Q2 2027 | $OCGN | Ocugen, Inc. | OCU400 planned BLA submission for retinitis pigmentosaPlanned filing; this is not FDA acceptance or approval. | Estimated window | Primary source |
| Q2 2027 | $TCRX | TScan Therapeutics, Inc. | TSC-101 update on patients treated with the commercial-ready manufacturing processCompany continues patient follow-up despite enrollment pause; exact day not announced. | Estimated window | Primary source |
| Q2 2027 | $BMEA | Biomea Fusion, Inc. | COVALENT-212 Phase 2 icovamenib Week 26 primary-endpoint topline on background GLP-1 therapyEnrollment still ongoing in the source release; date remains guidance. | Estimated window | Primary source |
| Q2 2027 | $KOD | Kodiak Sciences | KSI-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 window | Primary source |
| H2 2027 | $LTGO | Latigo Biotherapeutics, Inc. | Onzotrigine Phase 3 bunionectomy and open-label safety topline | Estimated window | Primary source |
| H2 2027 | $LTGO | Latigo Biotherapeutics, Inc. | LTG-321 Phase 2 topline in osteoarthritis knee pain | Estimated window | Primary source |
| H2 2027 | $BIOA | BioAge Labs, Inc. | QUELL-DME BGE-102 Phase 2 topline in diabetic macular edema | Estimated window | Primary source |
| H2 2027 | $ALT | Altimmune, Inc. | RESTORE Phase 2 pemvidutide topline in alcohol-associated liver diseaseEnrollment completed in July 2026. Topline concerns updated 48-week endpoint, not enrollment. Window-end marker is not an announced release day. | Estimated window | Primary source |
| By end-2026; day not announced | $RZLT | Rezolute | upLIFT ersodetug Phase 3 topline in tumor hyperinsulinism | Estimated milestone | Primary source |
| by the end of Q3 2026 | $TECX | Tectonic Therapeutic, Inc. | TX2100 Phase 1a topline | Estimated milestone | Primary source |
| Q3 2026 | $SCYX | SCYNEXIS, Inc. | SCY-770 Phase 1 topline | Estimated milestone | Primary source |
| H2 2026 | $IPHA | Innate Pharma S.A. | PACIFIC-9 Phase 3 monalizumab readout | Estimated milestone | Primary source |
| October 2026 | $TLSA | Tiziana Life Sciences Ltd. | INFORM-MS foralumab 12-week topline | Estimated milestone | Primary source |
| around mid-Q4 2026 | $OSTX | OS Therapies Incorporated | OST-HER2 confirmatory Phase 3 initiation | Estimated milestone | Primary source |
| Q4 2026 | $SCYX | SCYNEXIS, Inc. | SCY-770 Phase 2 proof-of-concept initiation | Estimated milestone | Primary source |
| Q4 2026 | $KYTX | Kyverna Therapeutics, Inc. | miv-cel rolling BLA submission completion in stiff person syndrome (SPS) | Estimated filing window | Primary source |
| Q4 2026 | $MIRM | Mirum Pharmaceuticals, Inc. | LIVMARLI EXPAND Phase 3 topline | Estimated milestone | Primary source |
| Q4 2026 | $ELDN | Eledon Pharmaceuticals, Inc. | LEGACY Phase 3 kidney-transplant trial initiation | Estimated milestone | Primary source |
| Q4 2026 | $XRTX | XORTX Therapeutics Inc. | XRx-026 gout IND submission | Estimated filing window | Primary source |
| Q4 2026 | $ORKA | Oruka Therapeutics, Inc. | EVERLAST-B ORKA-001 Week 16 data | Estimated milestone | Primary source |
| Q4 2026 | $TEVA | Teva Pharmaceutical Industries Limited | TEV-'749 olanzapine LAI PDUFA decision | Estimated PDUFA window | Primary source |
| December 2026 | $ORKA | Oruka Therapeutics, Inc. | EVERLAST-A ORKA-001 Week 52 data | Estimated milestone | Primary source |
| Q1 2027 | $XENE | Xenon Pharmaceuticals Inc. | X-NOVA2 azetukalner Phase 3 MDD toplineThe September 17 update retains Q1 2027: enrollment is complete; the pause concerns new patients in psychiatry programs. | Estimated milestone | Primary source |
| Q1 2027 | $FLNA | Filana Therapeutics, Inc. | simufilam TSC epilepsy Phase 2a screening | Estimated milestone | Primary source |
| Q1 2027 | $MIRA | MIRA Pharmaceuticals, Inc. | Ketamir-2 Phase 2a site initiation | Estimated milestone | Primary source |
| Q1 2027 | $PALI | Palisade Bio, Inc. | ASCENTRA-CD Phase 2 Crohn's first patient | Estimated milestone | Primary source |
| Q1 2027 | $IPHA | Innate Pharma S.A. | TELLOMAK-3 lacutamab first patient | Estimated milestone | Primary source |
| early 2027 | $ACIU | AC Immune SA | Planned FDA discussions on future development and Part 2 design of VacSYn, the Phase 2 trial of ACI-7104 in early Parkinson's disease | Estimated milestone | Primary source |
| Q1 2027 | $AEMD | Aethlon Medical, Inc. | NOR-101 Phase 1a start, proposed merger | Estimated milestone | Primary source |
| H1 2027 | $AZN | AstraZeneca PLC | efzimfotase alfa PDUFA action for hypophosphatasia | Estimated PDUFA window | Primary source |
| 2027 | $CLDX | Celldex Therapeutics, Inc. | barzolvolimab CSU BLA submission | Estimated filing window | Primary source |
| mid-2027 | $KYTX | Kyverna Therapeutics, Inc. | KYSA-6 Phase 3 miv-cel enrollment completion | Estimated milestone | Primary source |
| mid-2027 | $COAG | Hemab Therapeutics Holdings, Inc. | HMB-003 initial clinical data | Estimated milestone | Primary source |
| mid-2027 | $JAGX | Jaguar Health, Inc. | crofelemer MVID NDA filing | Estimated filing window | Primary source |
| mid-2027 | $AEMD | Aethlon Medical, Inc. | NOR-101 Phase 1a interim PK and safety data, proposed merger | Estimated milestone | Primary source |
| Mid-2027; day not announced | $CCCC | C4 Therapeutics | Cemsidomide + elranatamab Phase 1b data from evaluated cohorts | Estimated milestone | Primary source |
| H2 2027 | $SABS | SAB Biotherapeutics, Inc. | SAFEGUARD SAB-142 Phase 2b topline | Estimated milestone | Primary source |
| H2 2027 | $SCYX | SCYNEXIS, Inc. | SCY-770 Phase 2 early efficacy data | Estimated milestone | Primary source |
| H2 2027 | $LXEO | Lexeo Therapeutics, Inc. | SUNRISE-FA 2 LX2006 topline | Estimated milestone | Primary source |
| Q4 2027 | $LSTA | Lisata Therapeutics, Inc. | MAR001 severe hypertriglyceridemia Phase 2b topline | Estimated milestone | Primary source |
| Q4 2027 | $LSTA | Lisata Therapeutics, Inc. | MAR002 acromegaly Phase 2 topline | Estimated milestone | Primary source |
| early 2028 | $PALI | Palisade Bio, Inc. | ASCENTRA-CD Crohn's Phase 2 primary efficacy readout | Estimated milestone | Primary source |
| October 2026 | $IVVD | Invivyd, Inc. | DECLARATION Phase 3 safety and neutralizing-titer topline expected in October; clinical efficacy stays blinded. | Estimated window | Primary source |
| Q4 2026 | $MIRM | Mirum Pharmaceuticals | AZURE-4 Phase 3 brelovitug topline expected Q4 2026; separate from released AZURE-1. | Estimated window | Primary source |
| H1 2027 | $MIRM | Mirum Pharmaceuticals | Brelovitug BLA submission expected H1 2027; filing not yet completed. | Estimated window | Primary source |
| Q1 2027 | $RNAC | Cartesian Therapeutics | Descartes-08 AURORA Phase 3 topline expected Q1 2027; separate from registry primary-completion date. | Estimated window | Primary source |
| Early 2027 | $NKTR | Nektar Therapeutics | ZENITH AA Phase 3 rezpegaldesleukin initiation expected early 2027; June 30 is only a conservative window-end marker. | Estimated window | Primary source |
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 / window | Ticker | Company | Event | Status | Sources |
|---|---|---|---|---|---|
| Aug 12, 2026 — announcement | $ALT | Altimmune, 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 event | Primary source |
| Sep 21, 2026 | $NAMS | NewAmsterdam Pharma | Ubeslo / Evlarco: European Commission authorizationEU authorization announced September 21; the former September 28 estimated marker is resolved. | HISTORICAL · Completed event | Primary source |
| $GRAL | GRAIL | Galleri — 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 PENDING | GRAIL · FDA | |
| Sep 23, 2026 | $ARCT | Arcturus Therapeutics | ARCT-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 event | Primary source |
| 2026-09-24 | $MRK | Merck & Co. | Belzutifan plus lenvatinib FDA-approved September 24; former October 4 target resolved. | HISTORICAL · FDA approved | Primary source |
| $MIRM | Mirum Pharmaceuticals | Atebrioz (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 APPROVED | FDA | |
| 2026-09-25 | $MRK | Merck & Co. | Ifinatamab deruxtecan BLA voluntarily withdrawn September 25; former October 10 target superseded. Phase 3 continues. | HISTORICAL · Application withdrawn | Primary source |
| 2026-09-28 | $KOD | Kodiak Sciences | DAYBREAK: 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 published | Primary source |
| Sep 24, 2026 | $KYTX | Kyverna 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 released | Primary source |
| Sep 24, 2026 | $KYTX | Kyverna Therapeutics, Inc. | One-year miv-cel topline in stiff person syndrome released September 24, 2026. The former Q3 window is resolved. | HISTORICAL · Results released | Primary source |
| Sep 24, 2026 | $ACAD | Acadia 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 released | Primary source |
| 2026-09-28 | $ACET | Adicet Bio, Inc. | Prula-cel Phase 1 clinical data released in SLE/LN. | HISTORICAL — Results released | Primary source |
| 2026-09-28 | $MIRM | Mirum Pharmaceuticals | AZURE-1 Phase 3 brelovitug topline released; primary endpoint met. | HISTORICAL — Results released | Primary source |
| 2026-09-29 | $IVVD | Invivyd, Inc. | LIBERTY Phase 3 VYD2311 safety/tolerability topline released; distinct DECLARATION study remains pending. | HISTORICAL — Results released | Primary source |
| Q3 2026 | $IVVD | Invivyd, Inc. | Prior combined LIBERTY/DECLARATION forecast superseded by separate company updates on 29 September. | HISTORICAL — Superseded forecast | Primary source |
| 2026-09-28 | $IVA | Inventiva S.A. | First-half 2026 financial results published; 08:00 ET call announced, occurrence not separately verified. | HISTORICAL — Results released | Primary source |
| 2026-09-28 | $IMMP | Immutep Limited | Announced ADS-ratio change; market execution not independently verified. | HISTORICAL — Execution unverified | Primary source |
| 2026-09-28 | $SABS | SAB Biotherapeutics | SAB-142 Phase 1 presentation scheduled at EASD; occurrence not independently verified. | HISTORICAL — Occurrence unverified | Primary source |
| 2026-09-29 | $KYTX | Kyverna Therapeutics | KYSA-6 Phase 2 follow-up presentation scheduled at AANEM; occurrence not independently verified. | HISTORICAL — Occurrence unverified | Primary source |
| $SRPT | Sarepta Therapeutics | WMS Duchenne data presentationsScheduled scientific presentation, not an automatic pivotal readout. Stock Hub | HISTORICAL — Occurrence unverified | Primary source | |
| Sep 30, 2026 | $INCY | Incyte Corporation | STOP-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 readout | HISTORICAL — Occurrence unverified | Primary source |
| Sep 30, 2026 | $INCY | Incyte Corporation | TRuE-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 readout | HISTORICAL — Occurrence unverified | Primary source |
| Sep 30, 2026 | $SABS | SAB Biotherapeutics, Inc. | three SAB-142 Phase 1 presentations at EASD 2026 | HISTORICAL — Occurrence unverified | Primary source |
| Oct 1, 2026 · 16:30 CEST | $NKTR | Nektar Therapeutics | REZOLVE-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 released | Primary source |
| Oct 1, 2026 · 10:25 CEST | $NKTR | Nektar Therapeutics | REZOLVE-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 released | Primary source |
| Oct 1, 2026 · session 16:30–18:00 CEST | $ARTV | Artiva 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 unverified | Primary source |
| Oct 1, 2026 · 16:30 CEST | $EVMN | Evommune, 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 unverified | Primary source |
| Oct 2, 2026 | $SANA | Sana Biotechnology, Inc. | UP421 clinical-data symposium at EASD 2026Presentation day confirmed; no presentation time inferred. | HISTORICAL — Occurrence unverified | Primary source |
| $TRDA | Entrada Therapeutics | ENTR-601-44 pharmacokinetic / pharmacodynamic translation presentation at WMSScientific presentation; not assumed to be a new patient efficacy readout. Stock Hub | HISTORICAL — Occurrence unverified | Primary source | |
| Sep 27–30, 2026 (conference) | $BIAF | bioAffinity Technologies, Inc. | CyPath Lung posters at NAVREF 2026The individual poster presentation days have not been announced. | HISTORICAL — Occurrence unverified | Primary source |
| Q3 2026 | $QURE | uniQure 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 unverified | Primary source |
| Q3 2026 | $CRMD | CorMedix Therapeutics | REZZAYO prophylaxis sNDA submissionCompany-guided submission window; submission not yet confirmed in the sources reviewed. | HISTORICAL — Estimate expired; outcome unverified | Primary source |
| End of September 2026 | $MLTX | MoonLake Immunotherapeutics | Sonelokimab 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 unverified | Primary source 1 · Primary source 2 |
| Sep 30, 2026 | $BMY | Bristol Myers Squibb | CAMZYOS (mavacamten): FDA approved pediatric oHCM expansion for patients weighing at least 30 kg. | HISTORICAL — FDA approved | Primary 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.
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.
Type a ticker to get an AI-generated snapshot of the next catalyst (PDUFA, clinical data, regulatory events) with a link to the primary source.
Automatically generated AI snapshot
Enter a ticker to receive a snapshot generated by artificial intelligence using web sources. Responses are not individually checked by a person before they are displayed.
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.
For information and education only. Not investment advice or a recommendation to buy or sell securities.
Read the full disclaimerQuick definitions for FDA, clinical-trial, and “catalyst” terms used in the calendar & trackers.
| Term | Meaning |
|---|---|
| PDUFA date | FDA target action date for an NDA/BLA decision (often disclosed via filings/press releases). |
| Priority Review | FDA 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 Review | FDA review goal generally 10 months; clock start and pathway depend on the application. |
| AdCom | Advisory committee: reviews evidence and may vote; a meeting does not imply approval and its advice is not binding on FDA. |
| NDA / BLA | Applications to approve a drug (NDA) or a biologic (BLA). |
| sNDA / sBLA | Supplemental application (label expansion, new population, new formulation, etc.). |
| Filing acceptance | FDA 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/extension | FDA pushes the action date (more time needed for review, inspections, analyses, etc.). |
| Term | Meaning |
|---|---|
| Type A | Urgent/critical meeting (clinical hold, disputes, time-sensitive issues). |
| Type B | Standard “milestone” meeting (End-of-Phase, pre-NDA/BLA, etc.). |
| Type C | Other 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). |
| SPA | Special Protocol Assessment: FDA agrees in advance on design/endpoint of a key trial (not a guarantee). |
| Term | Meaning | Data released? |
|---|---|---|
| Enrollment Initiation | First sites/patients start enrolling. | NO |
| Enrollment Complete | Enrollment finished (no more new patients). | NO |
| Trial Completed | Final 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 Lock | Dataset is finalized for analysis (internal milestone). | NO |
| Interim Data | Results from an interim analysis, which may remain internal. They count as released data only when publicly disclosed. | IF DISCLOSED |
| Topline Data | High-level results release (often via PR/filing). | YES |
| Data Released / Readout | Results publicly disclosed; internal analysis alone does not constitute a public readout. | YES |
| Full Results / Full Dataset | Detailed results published or presented; does not necessarily mean access to the full raw dataset. | YES |
| Conference Presentation | Abstract, poster or oral presentation. A scheduled slot alone does not establish that new results have been released. | IF DISCLOSED |
| Publication | Peer-reviewed paper / full write-up. | YES |
| Term | Meaning |
|---|---|
| OS | Overall Survival. |
| PFS | Progression-Free Survival. |
| ORR | Objective Response Rate (CR + PR). |
| CR / PR | Complete / Partial Response. |
| SD / PD | Stable Disease / Progressive Disease. |
| DOR | Duration of Response. |
| AE / SAE | Adverse 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 / PD | Pharmacokinetics / Pharmacodynamics. |
| Biomarker | Biological marker used for selection/response/target engagement. |
| Term | Meaning |
|---|---|
| ODD | Orphan Drug Designation (rare-disease incentives). |
| FTD | Fast Track Designation (more frequent interactions; potential rolling submission). |
| BTD | Breakthrough Therapy Designation: preliminary clinical evidence of potential substantial improvement on clinically significant endpoints over available therapies for a serious condition. It is not approval. |
| RMAT | Designation 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 / PRV | RPDD 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. |
| Field | Meaning |
|---|---|
| Stage | Program phase (Preclinical, Phase 1/2/3, NDA/BLA Filing, PDUFA, etc.). |
| Status | Operational status (Ongoing, Trial Completed, Data Released, Clinical Hold, etc.). |
| Next catalyst | Next expected milestone (Topline, Interim, Conference, Submission, Regulatory Decision). |
| Catalyst date | Date or time window (exact / month / quarter / half / year / range). |
Glossary sources: FDA BTD · FDA RMAT · FDA RPDD/PRV · FDA SAE · ClinicalTrials.gov
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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Join @merlintraderpub_com on TelegramThe 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.