FDA Calendar Q4 2026: Key PDUFA Dates and Upcoming Approvals

Our FDA calendar for Q4 2026 has 43 dated decisions between October 20 and March 31: 23 in the last quarter of 2026 and 20 in the first quarter of 2027. This post lists every one of them with its modeled odds of approval in full. Nothing is locked. The first is bepirovirsen on October 26, the hepatitis B drug Ionis developed and GSK now runs, at 85%.

The spread is wide. At the top sit label expansions of drugs that are already on the market, led by Cytokinetics' MYQORZO, which our model rounds to 100%. At the bottom are BioXcel's IGALMI at 10% and NRx's ketamine product NRX-100 at 20%. November is the crowded month with 14 decisions, and 14 of the 38 exact dates land on a weekend.

The full list of upcoming PDUFA dates and FDA decisions (October 20, 2026 to March 31, 2027)

Which PDUFA dates are coming up in late October and November 2026?

Eight decisions fall between now and the middle of November, and they have very little in common.

Bepirovirsen (IONS) goes first, on October 26. Ionis developed it; GSK runs the program and would sell it. It has Priority Review and Breakthrough Therapy designation, and our model puts it at 85%. The goal is a functional cure of chronic hepatitis B, which is a harder thing to prove than keeping the virus quiet.

INOVIO (INO) follows on October 30 with INO-3107 for recurrent respiratory papillomatosis, filed for accelerated approval under a standard review. Modeled odds 70%. The stock is down 19.4% over the last 30 days going into it.

Then November opens. Agios (AGIO) has a supplemental application for mitapivat in sickle cell disease due November 1, a Sunday, at 72%. Regeneron (REGN) has cemdisiran for generalized myasthenia gravis at 88%, though the FDA gave only a month, not a day. NRx (NRXP) has November 10 for NRX-100, and that row needs a careful read: it is a GDUFA goal date on an abbreviated application, not a PDUFA date, and nothing we track confirms the FDA accepted the filing.

November 14 is a Saturday with three names on it: BioXcel's IGALMI (BTAI) at 10%, Cytokinetics' MYQORZO (CYTK) at 100% and Summit's ivonescimab (SMMT) at 62%. One day, the highest score on the list, the lowest, and the most argued-over lung cancer drug of the year.

Which upcoming FDA approvals in Q4 2026 have the highest odds?

Read the top of the table with some care. The highest numbers mostly belong to drugs that are already approved and are asking for a bigger label.

MYQORZO (CYTK) is the clearest case. Our model rounds it to 100% because aficamten is already approved and selling for obstructive hypertrophic cardiomyopathy. The November 14 decision is a supplement built on the MAPLE-HCM trial, so the score says more about the drug than about the new label. The same logic covers Merck's ENFLONSIA (MRK) at 99%, BioMarin's VOXZOGO (BMRN) at 99%, Insmed's ARIKAYCE (INSM) at 98% and Gilead's once-weekly Yeztugo tablet (GILD) at 94%. Supplements do get turned down, just much less often than new drugs. Two that were on this calendar did not even wait for their dates: the FDA approved Nuvation Bio's IBTROZI (NUVB) in ROS1-positive lung cancer and ImmunityBio's ANKTIVA (IBRX) in papillary bladder cancer, both months ahead of their goal dates, so both have left the list.

First approvals are where the numbers tell you more. Exelixis' zanzalintinib with atezolizumab (EXEL) leads at 92% in previously treated metastatic colorectal cancer, even after the FDA extended the review. Cullinan's zipalertinib (CGEM) sits at 89% in EGFR exon 20 lung cancer. Then comes a group at 88%: Vanda's imsidolimab (VNDA), Gilead and Arcellx's anito-cel (GILD), Regeneron's cemdisiran (REGN), Intellia's lonvo-z (NTLA) and Takeda's zasocitinib (TAK). Five more sit at 85%: bepirovirsen, Savara's molgramostim, GSK's neladalkib and both Praxis drugs.

High odds also tell you nothing about what a stock does on the day. Several of these have already moved a lot: CGEM is down 33.7% over 30 days and INSM is down 20.6%.

Which FDA decision dates look riskiest, and why?

Eight decisions carry modeled odds of 65% or lower, and the reasons repeat.

The lowest is IGALMI (BTAI) at 10%. That looks odd for a drug the FDA approved in 2022 for acute agitation in bipolar disorder and schizophrenia. The catch is the ask. BioXcel wants it used at home, without a clinician in the room, and that is a different safety question from use in a hospital. Our model is very skeptical.

NRX-100 (NRXP) is at 20% for a plainer reason. It is an abbreviated application with a GDUFA goal date, and nothing in the records we track confirms the FDA accepted it for review.

Four are second attempts after an FDA rejection: Unicycive's oxylanthanum carbonate (UNCY) at 25%, Atara's tab-cel (ATRA) at 35%, now filed by partner Pierre Fabre, Capricor's deramiocel (CAPR) at 42%, and Aquestive's Anaphylm (AQST) at 55%. A resubmission can work. The model just starts from the fact that the first one did not. UNCY's date is soft as well, because the company only says about six months from resubmission.

Summit's ivonescimab (SMMT) at 62% is the most debated name here. The HARMONi trial hit on progression-free survival, but overall survival fell short of statistical significance, and that gap is the question in front of the FDA.

Last is BridgeBio's oral infigratinib (BBIO) at 65% for children with achondroplasia. It has Priority Review and Breakthrough, but it is a first approval in children, and it will be judged against VOXZOGO, a daily injection already on the market.

What is at stake on November 22 for Capricor and Savara?

November 22 is a Sunday, and it carries two rare-disease decisions that the FDA pushed back by three months. Same delay, very different odds.

Capricor (CAPR) wants approval of deramiocel, a cell therapy for Duchenne muscular dystrophy. The FDA turned down the first application in 2025, saying the evidence of effectiveness was not enough. Capricor came back with HOPE-3, a placebo-controlled Phase 3 trial that met its primary endpoint, and resubmitted. The date then moved three months when the FDA accepted a major amendment with 24-month open-label data. Orphan Drug, RMAT and Priority Review are all in place.

Our model still puts it at only 42%, and the stock is down 26.6% over the last 30 days. Designations buy speed, not proof. With a cell therapy, a prior rejection and a review that keeps stretching, the model stays cautious until the FDA says otherwise.

Savara (SVRA) is the cleaner story. Molgramostim is an inhaled treatment for autoimmune pulmonary alveolar proteinosis, a rare lung disease where surfactant builds up in the air sacs and blocks oxygen. The Phase 3 IMPALA-2 trial hit its gas-transfer endpoint, and the drug holds Breakthrough, Orphan and Fast Track designations. The extension came during a Priority Review. Our model puts it at 85%, and SVRA is still down 13.8% over 30 days.

If you watch one date in November, this is a good one: two drugs, one day, and a 43-point gap in modeled odds.

Which decisions are label expansions, not first approvals?

Twelve of the 43 are supplements. The drug is already sold, and the company wants a new disease, a new group of patients, a new form or a firmer approval. They are worth keeping apart from first approvals because the risk is different.

New diseases: Agios' mitapivat (AGIO) in sickle cell disease at 72%, filed for accelerated approval. Pfizer's TALZENNA with XTANDI (PFE) in HRR gene-altered metastatic castration-sensitive prostate cancer at 82%, where Pfizer has only said the fourth quarter. GSK's dostarlimab, sold as Jemperli, in untreated stage II and III dMMR/MSI-H rectal cancer at 88%, with a February month and no day.

New patients: Pharming's Joenja (PHAR) for children aged 4 and older at 88%, Arcutis' ZORYVE cream (ARQT) for infants at 90%, Eton's LIBERVANT (ETON) for ages 6 to 11 at 82%, and Merck's ENFLONSIA (MRK) for at-risk children in their second RSV season at 99%.

New form or setting: Gilead's once-weekly Yeztugo tablet for HIV prevention (GILD) at 94%, and BioXcel's IGALMI (BTAI) for use at home at 10%.

New data or full approval: Cytokinetics' MYQORZO (CYTK) at 100%, BioMarin's VOXZOGO (BMRN) at 99%, and Insmed's ARIKAYCE (INSM) at 98%, which is moving from accelerated to full approval.

The IGALMI score is the reminder in this group. An approved drug is not automatically a safe bet on a new label. Two more supplements, for IBTROZI and ANKTIVA, were approved early and are no longer on the calendar.

What does the FDA calendar look like from December 2026 to March 2027?

After November's 14, the pace settles: 7 decisions in December, 4 in January, 8 in February and 8 in March.

December has the most commercial weight. Mineralys' lorundrostat (MLYS) for hypertension is due December 22 at 83%, a very large market if it gets there, though the stock is down 25.3% over 30 days. Gilead and Arcellx's anito-cel (GILD), a BCMA CAR-T for multiple myeloma after three prior lines, follows on December 23 at 88%. Vanda's imsidolimab (VNDA) lands on December 12, a Saturday, at 88%. Praxis' relutrigine (PRAX) and Viatris' fast-acting meloxicam (VTRS) share December 27. Cogent (COGT) has a second bezuclastinib date, December 30, in non-advanced systemic mastocytosis at 80%, a month after its GIST decision on November 30.

January brings Dyne's z-rostudirsen (DYN) for Duchenne patients amenable to exon 51 skipping on January 21 at 70%, and Praxis' second drug, ulixacaltamide for essential tremor, on January 29 at 85%. Like Cogent, Praxis has two first-approval decisions about a month apart.

February leans toward children. BridgeBio's oral infigratinib (BBIO) on February 4 and BioMarin's VOXZOGO on February 28 are both in achondroplasia, and Belite Bio's tinlarebant (BLTE) for Stargardt disease comes on February 12 at 72%. Apnimed's AD109 (APMD) for sleep apnea is due February 28 at 72%.

March closes with Intellia's one-time CRISPR treatment lonvo-z (NTLA) on March 10 at 88%, and Takeda's zasocitinib (TAK), a once-daily TYK2 pill for psoriasis, due sometime in the first quarter, also at 88%.

What happens when a PDUFA date falls on a weekend?

Fourteen of the 38 exact dates on this list fall on a Saturday or a Sunday; the other 5 rows give only a month or a quarter. That is not an error in the data. A goal date is set by counting months from the filing, and the count does not care what day it lands on.

There is no written FDA rule for weekend goal dates. In practice the decision usually comes by the last business day before, so a Saturday or Sunday date tends to mean a Friday answer. The agency can also act days or weeks early. Analysts who have tracked weekend dates found that approvals tend to be announced on or before the date, while rejection letters more often surface after it. Companies usually put the news out before the market opens or after it closes.

The weekend dates on this list: AGIO on November 1; BTAI, CYTK and SMMT on November 14; CAPR and SVRA on November 22; PYPD on November 28; VNDA on December 12; PRAX (relutrigine) and VTRS on December 27; PHAR on January 30; CGEM on February 27; and APMD and BMRN on February 28.

Three rows are not days at all. Pfizer gave only the fourth quarter for TALZENNA with XTANDI, Takeda gave only the first quarter for zasocitinib, and Unicycive's date is the company's own estimate. Treat those as windows. Regeneron and GSK's dostarlimab carry a month without a day, which is a narrower window but still a window.

How do our modeled odds of approval work?

Each number in the table is a probability of approval from our model. It starts from the historical approval rate for drugs at the same stage, then adjusts for what is known about this specific drug: the trial results, regulatory designations such as Breakthrough Therapy or Priority Review, safety signals, whether the application is a resubmission, and whether the drug is already approved for something else.

A few things are worth keeping in mind when you read them.

The model scores the drug, not the stock. A drug at 90% can still fall on approval if the label comes out narrower than hoped, and a drug at 40% can rally on a surprise yes. The run-up figures in the table, the share price change over the last 30 days, are there for exactly that reason.

Already-approved drugs score high almost by construction. That is why the top of the table is full of supplements, and why IGALMI at 10% stands out so sharply.

The odds move. They update when new information arrives: a review extension, an advisory committee, a rejection letter, a company update. The numbers here are as of October 20.

And they are estimates. Our model has been wrong before and will be again, mostly on the drugs in the middle of the range, where a single reviewer's concern can tip the answer. The live FDA calendar on BiopharmaWatch carries the current version of every number in this post, along with each company's cash runway, insider activity and news.

Why does each drug get the odds it does?

Every decision in the table, with the reasoning behind its modeled probability of approval.

• IONS bepirovirsen, 2026-10-26: modeled odds 85%. Priority Review, Breakthrough Therapy and GSK behind the filing; a functional cure is a high bar to prove.
• INO INO-3107, 2026-10-30: modeled odds 70%. A first-of-its-kind DNA medicine under accelerated approval, and RRP now has an approved treatment, which raises the bar.
• REGN cemdisiran (C5 RNAi therapy), 2026-11: modeled odds 88%. Priority Review bought with a voucher, and lowering C5 is already a proven approach in myasthenia gravis.
• AGIO mitapivat (PYRUKYND® / AQVESME™), 2026-11-01: modeled odds 72%. Already sold for another blood disorder, but sickle cell is a new disease and the filing rests on accelerated approval.
• NRXP NRX-100 (preservative-free intravenous ketamine), 2026-11-10: modeled odds 20%. A GDUFA goal on an abbreviated application, and we cannot confirm the FDA accepted the filing.
• BTAI IGALMI® (dexmedetomidine), 2026-11-14: modeled odds 10%. Approved for use in a hospital; a sedative at home without a clinician is the safety question the model doubts.
• CYTK MYQORZO (aficamten), 2026-11-14: modeled odds 100%. Already approved and selling; this supplement adds MAPLE-HCM data, so the score reflects the drug more than the label.
• SMMT ivonescimab (SMT112/AK112), 2026-11-14: modeled odds 62%. Positive on progression-free survival in HARMONi, but overall survival missed statistical significance.
• CAPR Deramiocel (CAP-1002), 2026-11-22: modeled odds 42%. Rejected once, back with positive HOPE-3 data, then delayed three months by a major amendment.
• SVRA molgramostim, 2026-11-22: modeled odds 85%. IMPALA-2 hit its gas-transfer endpoint, and the drug holds Breakthrough, Orphan and Fast Track.
• SNY venglustat, 2026-11-25: modeled odds 79%. Priority Review for the brain symptoms of type 3 Gaucher disease, which enzyme therapy cannot reach.
• BBIO BBP-418 (oral), 2026-11-27: modeled odds 79%. Positive Phase 3 topline, Priority Review, and the FDA says no advisory committee is planned.
• GSK neladalkib (NVL-655), 2026-11-27: modeled odds 85%. Priority Review for a brain-penetrant ALK drug in patients whose earlier ALK drugs stopped working.
• PYPD D-PLEX 100, 2026-11-28: modeled odds 72%. Priority Review and Breakthrough for a slow-release antibiotic implant placed during colorectal surgery.
• COGT bezuclastinib combination, 2026-11-30: modeled odds 83%. Priority Review and Breakthrough for a KIT inhibitor combination in GIST after imatinib.
• VRTX povetacicept, 2026-11-30: modeled odds 78%. Accelerated approval in IgA nephropathy, a route several recent kidney drugs have taken successfully.
• VNDA imsidolimab, 2026-12-12: modeled odds 88%. An orphan drug blocking IL-36, the same pathway as the GPP drug spesolimab, which is already approved.
• MLYS lorundrostat, 2026-12-22: modeled odds 83%. A new way to lower blood pressure in a huge, well-studied disease; potassium is the safety point to watch.
• GILD anito-cel, 2026-12-23: modeled odds 88%. A BCMA CAR-T in late-line myeloma, a setting where two CAR-Ts are already approved.
• PRAX relutrigine, 2026-12-27: modeled odds 85%. Orphan and Breakthrough in ultra-rare childhood epilepsies; the review was extended, not refused.
• VTRS MR-107A-02 (fast-acting meloxicam), 2026-12-27: modeled odds 78%. An old molecule in a new fast-acting form, so most of the safety picture is already known.
• COGT Bezuclastinib, 2026-12-30: modeled odds 80%. Breakthrough in non-advanced systemic mastocytosis, where avapritinib is already approved.
• PFE TALZENNA plus XTANDI (talazoparib + enzalutamide), Q4 2026: modeled odds 82%. A new use for two approved prostate cancer drugs; Pfizer has given only a quarter, not a day.
• DYN zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), 2027-01-21: modeled odds 70%. Priority Review, RMAT and Breakthrough, but exon-skipping drugs in Duchenne have a mixed record at the FDA.
• INSM ARIKAYCE (amikacin liposome inhalation suspension), 2027-01-28: modeled odds 98%. Already on the market under accelerated approval; this asks for full approval.
• PRAX ulixacaltamide, 2027-01-29: modeled odds 85%. Breakthrough in essential tremor with a new mechanism, in a disease whose main drugs are decades old.
• PHAR Joenja (leniolisib), 2027-01-30: modeled odds 88%. Approved from age 12; the supplement brings lower doses to children aged 4 and up.
• GSK dostarlimab (Jemperli), 2027-02: modeled odds 88%. Already approved in other cancers; the AZUR-1 rectal cancer data earned a Priority Review.
• GILD Yeztugo (lenacapavir) 300-mg tablets, 2027-02-02: modeled odds 94%. The same approved drug as a weekly tablet, so the question is the dosing, not the molecule.
• BBIO oral infigratinib, 2027-02-04: modeled odds 65%. A first approval in children, judged against VOXZOGO, which is already on the market.
• BLTE tinlarebant (LBS-008), 2027-02-12: modeled odds 72%. Priority Review, Breakthrough and Orphan in Stargardt disease, which has no approved drug.
• ARQT ZORYVE (roflumilast) cream 0.05%, 2027-02-23: modeled odds 90%. Already approved for older patients; the supplement extends the cream down to infants.
• CGEM zipalertinib, 2027-02-27: modeled odds 89%. EGFR exon 20 lung cancer after chemotherapy, partnered with Taiho; the stock has fallen hard regardless.
• APMD AD109, 2027-02-28: modeled odds 72%. Two Phase 3 trials behind a nightly pill aimed at the airway collapse in sleep apnea, not just the sleepiness.
• BMRN VOXZOGO (vosoritide), 2027-02-28: modeled odds 99%. Approved and selling; this supplement adds long-term data, including adult height.
• EXEL zanzalintinib in combination with atezolizumab, 2027-03-03: modeled odds 92%. Strong data in previously treated colorectal cancer; the FDA extended the review rather than ruling.
• NTLA lonvoguran ziclumeran (lonvo-z), 2027-03-10: modeled odds 88%. A one-time CRISPR infusion with Priority Review and RMAT, edited inside the body rather than in a lab.
• AQST Anaphylm (dibutepinephrine) sublingual film (AQST-109), 2027-03-16: modeled odds 55%. A resubmission after an earlier rejection; the film has to deliver epinephrine as reliably as an injection.
• MRK ENFLONSIA (clesrovimab-cfor), 2027-03-22: modeled odds 99%. Already approved for the first RSV season; this extends it to at-risk children in their second.
• ETON LIBERVANT (diazepam) buccal film, 2027-03-29: modeled odds 82%. A label update adding ages 6 to 11 to an approved seizure rescue film.
• UNCY Oxylanthanum Carbonate (OLC), 2027-03 (est.): modeled odds 25%. Rejected once; the new date is the company's own estimate, not one the FDA has confirmed.
• ATRA tabelecleucel (Tab-cel), 2027-03-31: modeled odds 35%. Rejected before; partner Pierre Fabre resubmitted, and the model stays cautious on a second attempt.
• TAK zasocitinib (TAK-279), Q1 2027: modeled odds 88%. Priority Review for a once-daily TYK2 pill in psoriasis, a drug class the FDA has approved before.

The bottom line

If the model is roughly right, most of these 43 decisions end in approval. The ones worth your attention are where the score and the story pull apart: an approved drug at 10%, rejected drugs trying again, and two delayed rare-disease drugs on the same Sunday with a 43-point gap between them. Keep the FDA calendar open through November, check the dates as they move, and read each number as a starting point, not a verdict.