November 2026 FDA Calendar: 16+ Decisions, Seven in Four Days, Three Possible Firsts

Key Highlights

• At least sixteen FDA actions carry November goal dates, more than double October's six.
• Seven of fourteen dated decisions fall between November 27 and 30, around Thanksgiving.
• BridgeBio, Sanofi and Roche each say approval would be a first for their disease.
• Capricor returns after a 9 to 3 negative panel vote, testing evidence standards.
• Two applications changed sponsors and two others moved into 2027.

October Closed Without a Miss

All six FDA actions with October goal dates ended in approval, as did two applications with later or undated windows. Roche Holding AG (OTC:RHHBY) announced Tecentriq's adjuvant colon cancer expansion on October 9, its goal date, and Enspryng's thyroid eye disease approval on October 16. Viatris Inc. (NASDAQ:VTRS) announced Ryzumvi's presbyopia approval on October 16. GSK plc (NYSE:GSK) announced Hibsago (bepirovirsen) on October 20, ahead of an October 26 goal date. Pooled B-Well data showed functional cure in 19% of patients against 0% on placebo.

Sun Pharmaceutical Industries Ltd. (NSE:SUNPHARMA) announced Ilumya's psoriatic arthritis approval on October 30. Inovio Pharmaceuticals Inc. (NASDAQ:INO) announced accelerated approval for Voceryq on its October 30 goal date, based on reduced surgery frequency. Seven of 26 patients with at least three baseline surgeries needed none in the first year, and a confirmatory study is required. Pfizer Inc. (NYSE:PFE) announced approval of Talzenna plus Xtandi on October 26. NRx Pharmaceuticals Inc. (NASDAQ:NRXP) won approval of a generic preservative-free ketamine on October 30, ahead of a November 10 goal date. The advisory committee for Sydnexis (privately held) agreed with FDA reviewers that its primary endpoint result was borderline and statistically fragile.

How November Is Built

Thirteen of the sixteen actions are original applications, including one resubmission, and three are supplements. Fourteen carry a stated date and two carry only a November window. Six of the fourteen fall on a weekend, on November 14, 22 and 28, so action may come on the preceding Friday. Three applications say approval would be a first for their disease: Sanofi's venglustat on November 25, BridgeBio's BBP-418 on November 27 and Roche's Gazyva in an undated November window. Each claim is the company's own and depends on approval.

November 14 to 17: A Contested Survival Case Opens the Month

The opening block pairs a debated survival dataset with three smaller decisions.

Summit Therapeutics Inc. (NASDAQ:SMMT). November 14, a Saturday. Ivonescimab plus chemotherapy for EGFR-mutated non-squamous lung cancer after prior TKI therapy. In HARMONi, the overall survival hazard ratio was 0.79 at the primary analysis (p=0.057, not significant), 0.78 at a September 2025 cutoff (nominal p=0.0332) and 0.76 at a June 2026 cutoff (nominal p=0.0151). Summit's February filing described ivonescimab as approved only in China.

Cytokinetics, Incorporated (NASDAQ:CYTK). November 14, a Saturday. A supplement for MYQORZO based on MAPLE-HCM, which compared aficamten with metoprolol in obstructive hypertrophic cardiomyopathy.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA). November 14, a Saturday. A supplement seeking at-home use of IGALMI. Teva completed its purchase of IGALMI and the pending supplement from BioXcel Therapeutics, which filed for Chapter 11 protection, on October 26.

Beren Therapeutics. November 17. Adrabetadex for infantile-onset Niemann-Pick disease type C, extended by three months after the FDA classified a March 18 response to an information request as a major amendment.

November 22 to 25: Two Extended Reviews and a Neurological Claim

The second block is defined by delay and the first disease-first claim.

Savara Inc. (NASDAQ:SVRA). November 22, a Sunday. Molgramostim for autoimmune pulmonary alveolar proteinosis, under priority review. The FDA extended the review by three months after classifying Savara's responses to information requests as a major amendment, and cited no safety, efficacy or manufacturing concerns.

Capricor Therapeutics Inc. (NASDAQ:CAPR). November 22, a Sunday. Deramiocel for Duchenne muscular dystrophy, a Class 2 resubmission extended from August 22. On July 29 an advisory committee voted 9 to 3 that the evidence did not support effectiveness in Duchenne cardiomyopathy. FDA reviewers cited late changes to the statistical analysis plan that lacked adequate scientific justification. Capricor has since asked the agency to review a narrower indication, upper limb function, with 24-month open-label extension data.

Sanofi (NASDAQ:SNY). November 25. Venglustat for type 3 Gaucher disease, under priority review. Sanofi says it would be the first US treatment for the disease's progressive neurological manifestations. LEAP2MONO, which enrolled 43 patients and compared the oral drug with intravenous enzyme replacement, met both primary endpoints at week 52. The small sample is the main interpretive constraint.

November 27 to 30: Seven Decisions in Four Days

Seven decisions fall between Friday, November 27, the day after Thanksgiving, and Monday, November 30.

BridgeBio Pharma Inc. (NASDAQ:BBIO). November 27. BBP-418 for limb-girdle muscular dystrophy type 2I/R9, under priority review, with no advisory committee planned. BridgeBio says approval would be the first for this disease and potentially for any form of limb-girdle muscular dystrophy. FORTIFY met all primary and secondary endpoints at its 12-month interim analysis, though the release gave no effect sizes.

GSK plc. November 27. Neladalkib for TKI-pretreated ALK-positive lung cancer, under priority review. GSK completed its Nuvalent acquisition on July 15. In ALKOVE-1, the response rate was 31% across 253 TKI-pretreated patients.

Zydus Lifesciences Ltd. (NSE:ZYDUSLIFE). November 27. Saroglitazar for primary biliary cholangitis, under priority review. In the 148-patient EPICS-III trial, 56.7% met the biochemical response endpoint at week 52 against 9.8% on placebo. A pruritus endpoint was significant at week 24 but not week 52.

PolyPid Ltd. (NASDAQ:PYPD). November 28, a Saturday. D-PLEX100 for preventing surgical site infection after abdominal colorectal surgery, under priority review. SHIELD II showed a 60% relative risk reduction. PolyPid held $6.6 million in cash at June 30, excluding $30 million in upfront and near-term milestone payments from its Azurity commercialization partnership.

Cogent Biosciences Inc. (NASDAQ:COGT). November 30. Bezuclastinib plus sunitinib for imatinib-treated gastrointestinal stromal tumors, under priority review, with no advisory committee planned. In PEAK, median progression-free survival was 16.5 versus 9.2 months (hazard ratio 0.50). Grade 3 or higher ALT or AST elevations occurred in 10.8% versus 1.4%.

Roche Holding AG. November 30. Giredestrant for adjuvant ER-positive, HER2-negative early breast cancer, under priority review. In lidERA, invasive disease-free survival favored giredestrant (hazard ratio 0.70), with three-year rates of 92.4% versus 89.6%. Overall survival data are immature.

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). November 30. Povetacicept for IgA nephropathy, filed for accelerated approval. At week 36 of RAINIER, proteinuria fell 49.8% versus placebo, and Vertex reported no drug-related serious adverse events. The final analysis will use eGFR slope through week 104, so the approval question rests on a surrogate.

No Day Disclosed

Two applications carry only a November window, so timing is least predictable here.

Roche Holding AG. November, no day disclosed. Gazyva for adults with primary membranous nephropathy, a supplemental application under priority review. Roche says it would be the first approved therapy for the disease. In MAJESTY, which randomized 142 adults, complete remission at week 104 was 36.9% versus 5.7% on tacrolimus, with no new safety signals reported.

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN). November, no day disclosed. Cemdisiran, a C5 RNAi therapy for anti-AChR antibody-positive generalized myasthenia gravis, under priority review obtained with a priority review voucher. Regeneron licensed it from Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) and is solely responsible for its development.

Dates That Moved

Two reviews due before year-end have slipped into 2027.

Agios Pharmaceuticals Inc. (NASDAQ:AGIO). Mitapivat's sickle cell goal date moved from November 1 to February 1, 2027 after the FDA classified Agios's response to a REMS information request as a major amendment on October 28. The question followed liver injury seen in thalassemia trials, and Agios reports no sickle cell cases resembling that pattern.

Exelixis Inc. (NASDAQ:EXEL). Zanzalintinib plus atezolizumab for previously treated metastatic colorectal cancer moved from December 3 to March 3, 2027 after the FDA deemed updated data a major amendment.

What the Month Tests

The first question is whether the firsts hold. They rest on different evidence: a 43-patient trial, an interim analysis without published effect sizes, and a randomized study against tacrolimus.

The second is evidence at the margin. Capricor's panel history, Summit's survival data, where the primary analysis missed significance and later cuts carry only nominal p-values, and Vertex's surrogate endpoint each ask whether the agency will accept evidence short of a clean result, as it did for Inovio in October.

The third is timing. Savara, Capricor and Beren have each been extended once, and Agios and Exelixis show how quickly a date can move. Funding is a further variable for smaller sponsors such as PolyPid. A calendar that lists sixteen dates as equivalent would understate how different their risk profiles are.