Q4 2026 PDUFA dates still ahead, as of November 10: 18 dated FDA decisions from November 14 to December 30, 11 of them in November and 7 in December. Nine of the 18 fall on a Saturday or Sunday, three reviews were pushed back three months into the quarter, and two are second attempts after an earlier rejection. This report lists every one, with the full picture for three of them: Cytokinetics, Summit Therapeutics and Capricor.
The free PDF has all 10 pages: download the Q4 2026 PDUFA report.
Eighteen with a set day. Three more companies give a decision only as a month or a quarter: Regeneron (cemdisiran in generalized myasthenia gravis, November 2026), Novo Nordisk (CagriSema, Q4 2026) and Alvotech (three proposed biosimilars, Q4 2026).
| Date | Company | Drug | For | Filing | PoA |
|---|---|---|---|---|---|
| November 14 (Sat) | Teva (TEVA) | IGALMI | agitation in bipolar disorder or schizophrenia, at home | sNDA | On BiopharmaWatch |
| November 14 (Sat) | Cytokinetics (CYTK) | MYQORZO (aficamten) | obstructive HCM, MAPLE-HCM label update | sNDA | 99.99% |
| November 14 (Sat) | Summit Therapeutics (SMMT) | ivonescimab | EGFR-mutated non-small cell lung cancer | BLA | 62% |
| November 22 (Sun) | Savara (SVRA) | molgramostim | autoimmune pulmonary alveolar proteinosis | BLA | On BiopharmaWatch |
| November 22 (Sun) | Capricor (CAPR) | deramiocel | Duchenne muscular dystrophy | BLA | 62% |
| November 25 (Wed) | Sanofi (SNY) | venglustat | type 3 Gaucher disease | NDA | On BiopharmaWatch |
| November 27 (Fri) | BridgeBio (BBIO) | BBP-418 | limb-girdle muscular dystrophy 2I/R9 | NDA | On BiopharmaWatch |
| November 27 (Fri) | GSK (GSK) | neladalkib | ALK-positive non-small cell lung cancer | NDA | On BiopharmaWatch |
| November 28 (Sat) | PolyPid (PYPD) | D-PLEX 100 | surgical site infection prevention | NDA | On BiopharmaWatch |
| November 30 (Mon) | Cogent Biosciences (COGT) | bezuclastinib + sunitinib | GIST after imatinib | NDA | On BiopharmaWatch |
| November 30 (Mon) | Vertex (VRTX) | povetacicept | IgA nephropathy | BLA | On BiopharmaWatch |
| December 12 (Sat) | Vanda (VNDA) | Quimilza | generalized pustular psoriasis | BLA | On BiopharmaWatch |
| December 17 (Thu) | Corcept (CORT) | relacorilant | Cushing's syndrome | NDA | On BiopharmaWatch |
| December 22 (Tue) | Mineralys (MLYS) | lorundrostat | hypertension, added to other drugs | NDA | On BiopharmaWatch |
| December 23 (Wed) | Gilead (GILD) | anito-cel | relapsed or refractory multiple myeloma | BLA | On BiopharmaWatch |
| December 27 (Sun) | Viatris (VTRS) | fast-acting meloxicam | moderate to severe acute pain | NDA | On BiopharmaWatch |
| December 27 (Sun) | Praxis Precision Medicines (PRAX) | relutrigine | SCN2A and SCN8A epileptic encephalopathies | NDA | On BiopharmaWatch |
| December 30 (Wed) | Cogent Biosciences (COGT) | bezuclastinib | nonadvanced systemic mastocytosis | NDA | On BiopharmaWatch |
Nine of the 18: November 14 (three decisions), November 22 (two), November 28, December 12 and December 27 (two). A PDUFA goal date follows the review clock, not the trading week. When it lands on a weekend, the FDA can act on the business day before, so the news may come on a Friday, sometimes after the close.
The holiday weeks are busy too. November 27, the day after Thanksgiving, has BridgeBio (BBIO) and GSK (GSK). From December 23 to 30 there are four decisions: Gilead (GILD), Viatris (VTRS), Praxis Precision Medicines (PRAX) and Cogent Biosciences (COGT), whose second decision of the quarter falls on December 30.
Three reviews were extended by three months. Savara (SVRA)'s molgramostim in autoimmune pulmonary alveolar proteinosis moved to November 22, under priority review. Praxis (PRAX)'s relutrigine in SCN2A and SCN8A epileptic encephalopathies moved from September 27 to December 27 after the company sent added analyses. Capricor's deramiocel is both a delay and a second attempt (below).
Corcept (CORT) is back with a resubmitted NDA for relacorilant in Cushing's syndrome, with a decision due by December 17. One date moved the other way: PolyPid (PYPD) got priority review for D-PLEX 100, and its November 28 date is about one quarter earlier than the company had guided.
Seven of the 17 companies have no approved drug: Summit, Savara, Capricor, PolyPid, Cogent, Mineralys and Praxis, with 8 of the 18 decisions between them. In our Biotech Anatomy 2026 report, since 2021 first-time sponsors got a complete response letter on 44% of first decisions, against 24% for experienced sponsors. A first-time complete response letter cost a median 27% of the stock by the next day's close.
Three decisions on one Saturday. Cytokinetics (CYTK) waits on a label update for MYQORZO (aficamten), which is already approved in obstructive hypertrophic cardiomyopathy; this application adds data from MAPLE-HCM. Its probability of approval on BiopharmaWatch is 99.99%, and options price a move of about ±8.8% by the Nov 20 expiry.
Summit Therapeutics (SMMT) waits on ivonescimab in EGFR-mutated non-small cell lung cancer, filed on the HARMONi trial. Its probability of approval is 62%, and options price about ±25.8% by Nov 20.
Teva (TEVA) waits on IGALMI for agitation in bipolar disorder or schizophrenia at home; the drug is approved today for use under a health care provider's supervision. BioXcel Therapeutics set the November 14 date before the sale: Teva bought IGALMI and BXCL501 from BioXcel Therapeutics in a court-supervised sale that closed on October 26, 2026.
November 22, 2026. Capricor (CAPR) received a complete response letter for deramiocel in Duchenne muscular dystrophy in July 2025. After it sent data from the HOPE-3 trial, the FDA classed the filing as a Class 2 resubmission with an August 22 date, then extended it by three months to November 22 after a major amendment.
Capricor is the most open row in this report. Its probability of approval on BiopharmaWatch is 62%. Options price a move of about ±88.5% by the Nov 27 expiry (as of November 9), the largest of the three open names. 8 tracked hedge funds held the stock at June 30, 2026: 3 raised their stake, 1 cut and 1 was new. No insider bought or sold on the open market in the 90 days to November 10.
For the three open names, the options market prices about ±88.5% for Capricor, ±25.8% for Summit and ±8.8% for Cytokinetics. The same figure for the other 15 decisions is on the FDA calendar.
At June 30, 2026, 13 tracked hedge funds held Cytokinetics (4 new, 2 raised, 3 cut), 4 held Summit (3 of them new) and 8 held Capricor. The third-quarter 13F filings are due on November 16 and will show who moved into the decisions.
Not at the three open names. From August 12 to November 10, 5 Cytokinetics insiders sold about $11.9M of stock on the open market and none bought. Summit and Capricor had no open-market insider trades in the same 90 days. Every Form 4 for the other 15 companies is on their company pages.
Seven. Vanda (VNDA) has Quimilza in generalized pustular psoriasis on December 12. Corcept follows on December 17 and Mineralys (MLYS) has lorundrostat in hypertension on December 22. Gilead's anito-cel in multiple myeloma, which came with the Arcellx deal, is due December 23. Viatris (fast-acting meloxicam) and Praxis share December 27, and Cogent closes the year with bezuclastinib in nonadvanced systemic mastocytosis on December 30.
On the PDUFA calendar, which shows the probability of approval for all 18 decisions with the reasons behind each. The options-implied move is on the FDA calendar, and hedge fund and insider moves are on each company page. For catalyst alerts on the companies you follow, see the plans. The 10-page PDF of this report is free: download it here.
Data as of November 10, 2026. Dates move; the PDUFA calendar has the current version. Data, not investment advice.