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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 U.S.-listed biotech stocks.
Table and 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 U.S. biotech and healthcare companies.
Each entry is designed to show the expected timing, event type, company context and available source trail. Confirmed FDA dates are listed in the table below, each with its primary source, and the embedded calendar also includes estimated clinical windows, which must be distinguished from confirmed FDA dates.
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.
Selected regulatory dates confirmed by FDA notices, SEC filings and sponsor releases, with resolved outcomes distinguished from future deadlines. Each entry links to its primary source. Estimated windows and trial completion dates are excluded: they are not dates for the release of results. This selection does not cover every FDA application.
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $IONS | Ionis Pharmaceuticals | Zanvastro (zilganersen) — Alexander disease in pediatric and adult patientsApproved September 3, 2026; no longer a pending September 22 decision. | FDA APPROVED — resolved | Ionis / SEC · FDA | |
| $AZN | AstraZeneca | Etcamah (camizestrant) + CDK4/6 inhibitor — adults with HR+/HER2− locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during aromatase inhibitor and CDK4/6 therapy using an FDA-authorized testFDA accelerated approval September 4, 2026, based on SERENA-6. | ACCELERATED APPROVAL | FDA · AstraZeneca | |
| $PHAR | Pharming Group | Joenja (leniolisib) — APDS, pediatric extension for ages 4–11 and body weight at least 27 kgFDA approval September 11, 2026; the former October 24 PDUFA is resolved. | FDA APPROVED — resolved | SEC / Pharming | |
| $SRRK | Scholar Rock | ISEMBYLD (apitegromab-mstn) — spinal muscular atrophyFDA approval September 11, 2026, ahead of the former September 30 PDUFA. Adults and children aged 2 or older receiving an SMN2-targeted treatment. | FDA APPROVED — resolved | Scholar Rock · FDA | |
| $TLX | Telix Pharmaceuticals | Pixclara (floretyrosine F 18) — PET imaging of gliomaFDA approval announced September 14, 2026. Adults and pediatric patients aged one month and older; used with other diagnostic evaluations to distinguish recurrence or progression from treatment-related change. September 11 is also the FDA approval date, now confirmed by the FDA approval register. | FDA APPROVED — resolved | Telix release | |
| $BFRI | Biofrontera | Ameluz (aminolevulinic acid gel) with BF-RhodoLED lamps — photodynamic therapy of superficial basal cell carcinoma in adultsApproval announced September 14; former September 28 target resolved. Announcement date is distinguished from the administrative approval date.Commercial launch planned for late Q4 2026 through Q1 2027: sponsor guidance, with no exact date. | FDA APPROVED — resolved | FDA label · Announcement | |
| $RARE | Ultragenyx Pharmaceutical | FAYUVI (UX111; rebisufligene etisparvovec-hopf)Full FDA approval September 17, 2026, for neurologic manifestations of MPS IIIA in pediatric patients with preserved neurodevelopmental function. Former September 19 PDUFA resolved. | FDA APPROVED — resolved | FDA · SEC 8-K | |
| $MRK | Merck & Co. | Winrevair (sotatercept-csrk) — label update in pulmonary arterial hypertension, HYPERION trial | PDUFA (sBLA) | Source | |
| $GRAL | GRAIL | Galleri, multi-cancer diagnostic test — multi-cancer early detection in adults aged 50 and overMolecular and Clinical Genetics Panel, on a diagnostic device PMASeptember 23 meeting, 9 a.m.–6 p.m. Eastern Time. This is an advisory committee meeting, not an approval date. | AdCom | Source | |
| $MIRM | Mirum Pharmaceuticals | zilurgisertib, oral ALK2 inhibitor — fibrodysplasia ossificans progressiva, aged 12 and overLicensed from Incyte. The filing reports that the pivotal study missed statistical significance on its primary endpoint; the NDA is supported by secondary endpoints. | PDUFA | Source | |
| $BMY | Bristol Myers Squibb | Camzyos (mavacamten) — extension to adolescents with symptomatic obstructive hypertrophic cardiomyopathyProposed population: ages 12 to under 18. | PDUFA (sNDA) | Source |
| Date | Ticker | Company | Event | Type | Source |
|---|---|---|---|---|---|
| $MRK | Merck & Co. | Welireg (belzutifan) with Lenvima (lenvatinib) — advanced clear cell renal cell carcinoma, after a PD-1 or PD-L1 inhibitorBelzutifan + lenvatinib combination, LITESPARK-011 study. | PDUFA (sNDA) | Source | |
| $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 | |
| $MRK | Merck & Co. | ifinatamab deruxtecan (I-DXd) — extensive-stage small cell lung cancer, after platinum-based chemotherapyco-developed with Daiichi Sankyo | PDUFA | 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 |
| Date | Ticker | Company | Event | Type | 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 — Duchenne muscular dystrophy cardiomyopathyClass 2 resubmission after the July 2025 CRL; on 24 August 2026 the FDA extended the target action date from 22 August to 22 November 2026, classifying the amendment containing 24-month HOPE-3 data as a major amendment | PDUFA | 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 |
| Date | Ticker | Company | Event | Type | 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 | |
| $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 |
| Date | Ticker | Company | Event | Type | 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 |
September outcomes remain visible as resolved events, sorted by approval date or, where specified, announcement date. Future dates are review goals, not promises of approval, and can be extended. EXEL is now March 3, 2027, not December 3, 2026. Sponsor releases are cross-checked against FDA/SEC documents where available; some prospective deadlines are disclosed only by the sponsor. Educational content, not investment advice.
A free Biotech Catalyst Calendar is available as an embedded calendar and as a table of confirmed FDA dates, designed to help traders track upcoming price-moving events such as clinical trial readouts, FDA decisions, and regulatory milestones. Every date in the table is confirmed by a primary source and linked to it.
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
Sources: FDA documents, SEC filings, sponsor releases and ClinicalTrials.gov. The table’s regulatory dates were rechecked September 19, 2026. The embedded calendar is a wider archive and can include estimates, monthly placeholders and historical records; this table review does not certify every archive entry. ClinicalTrials.gov dates refer to data collection, not public readouts. Dates without a time are all-day events; stated times use Eastern Time.
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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.
