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PDUFA Calendar: Upcoming FDA Decision Dates
Every upcoming FDA drug-decision (PDUFA) date BioRadar is tracking, month by month, with approval-probability scores and the move the options market prices in. Updated automatically from SEC and FDA filings, last refreshed November 7, 2026.
The next FDA decision is CYTK (aficamten) on November 14, 2026, 7 days away. BioRadar is tracking 45 upcoming PDUFA dates — 7 in the next 30 days and 19 in the next 90 days — through June 2027.
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A PDUFA date is the FDA's target action date for deciding on a drug application. On that date the FDA typically approves the drug, issues a Complete Response Letter (rejection), or extends the review. These are binary, high-variance catalysts — see how biotech stocks have historically moved around FDA decisions.
Implied move = what the options market prices in: the at-the-money straddle of the first option expiry after each PDUFA date, as a share of the stock price (Yahoo Finance quotes, updated every trading day). It covers every move until that expiry, not only the FDA decision. Thinly traded options are left out.
PDUFA dates in November 2026 (7)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| Nov 14 | CYTK | aficamten — obstructive hypertrophic cardiomyopathy | sNDA | 86% | ±9% | 7d |
| Nov 14 | SMMT | ivonescimab — EGFRm NSCLC post-TKI therapy | BLA | 64% | ±31% | 7d |
| Nov 14 | BTAI | IGALMI — agitation associated with bipolar disorders or | sNDA | 76% | – | 7d |
| Nov 27 | BBIO | BBP-418 — LGMD2I/R9 | NDA | 66% | ±12% | 20d |
| Nov 28 | PYPD | D-PLEX₁₀₀ — prevention of surgical site infections in abdo | NDA | 68% | – | 21d |
| Nov 30 | ZLAB | Povetacicept (Vertex) — immunoglobulin A nephropathy (IgAN) | BLA | 64% | ±23% | 23d |
| Nov 30 | COGT | bezuclastinib — GIST | NDA | 66% | ±19% | 23d |
PDUFA dates in December 2026 (7)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| Dec 12 | VNDA | Quimilza — generalized pustular psoriasis (GPP) | BLA | 67% | ±36% | 35d |
| Dec 17 | CORT | Relacorilant — Cushing's syndrome | NDA | 51% | ±29% | 40d |
| Dec 22 | MLYS | lorundrostat — hypertension in combination with other antihyp | NDA | 66% | ±38% | 45d |
| Dec 23 | GILD | anito-cel — relapsed or refractory multiple myeloma | BLA | 61% | ±11% | 46d |
| Dec 23 | ACLX | anito-cel — relapsed or refractory multiple myeloma | BLA | 61% | – | 46d |
| Dec 27 | PRAX | relutrigine — SCN2A/SCN8A developmental epileptic encephalop | NDA | 61% | ±34% | 50d |
| Dec 30 | COGT | bezuclastinib — nonadvanced systemic mastocytosis | NDA | 66% | ±29% | 53d |
PDUFA dates in January 2027 (4)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| Jan 21 | DYN | z-rostudirsen — exon 51 Duchenne muscular dystrophy | BLA | 69% | ±59% | 75d |
| Jan 28 | INSM | ARIKAYCE — Mycobacterium avium complex lung disease | sNDA | 86% | ±24% | 82d |
| Jan 29 | PRAX | ulixacaltamide — essential tremor | NDA | 71% | ±43% | 83d |
| Jan 30 | PHAR | Joenja — children with APDS | sNDA | 91% | – | 84d |
PDUFA dates in February 2027 (8)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| Feb 4 | BBIO | oral infigratinib — achondroplasia | NDA | 66% | ±20% | 89d |
| Feb 12 | BLTE | tinlarebant — Stargardt disease type 1 | NDA | 66% | ±39% | 97d |
| Feb 18 | ARGX | efgartigimod — pediatric generalized myasthenia gravis | sBLA | 88% | ±15% | 103d |
| Feb 23 | ARQT | ZORYVE cream 0.05% — infants with mild to moderate atopic dermatiti | sNDA | 89% | ±32% | 108d |
| Feb 27 | CGEM | Zipalertinib — relapsed EGFR ex20ins NSCLC | NDA | 66% | – | 112d |
| Feb 28 | APMD | AD109 (Oxnimbi) | NDA | 66% | – | 113d |
| Feb 28 | PVLA | QTORIN™ Rapamycin — microcystic lymphatic malformations | NDA | 66% | – | 113d |
| Feb 28 | BMRN | VOXZOGO — children with achondroplasia | NDA | 66% | ±19% | 113d |
PDUFA dates in March 2027 (5)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| Mar 10 | NTLA | lonvoguran ziclumeran — hereditary angioedema | BLA | 64% | ±45% | 123d |
| Mar 16 | AQST | Anaphylm (dibutepinephrine) Sublin | NDA | 61% | – | 129d |
| Mar 23 | AQST | Libervant (unnamed licensee) — patients twelve years of age and older | NDA | 66% | ±74% | 136d |
| Mar 29 | AQST | Libervant — patients six to eleven years of age | NDA | 66% | ±74% | 142d |
| Mar 29 | ETON | VALTOCO (Aquestive) — seizure rescue in ages 6 to 11 | NDA | 66% | ±40% | 142d |
PDUFA dates in April 2027 (5)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| Apr 1 | HRMY | Pitolisant GR — narcolepsy | NDA | 66% | ±31% | 145d |
| Apr 14 | INBX | ozekibart — unresectable or metastatic conventional chondr | BLA | 59% | – | 158d |
| Apr 16 | JAZZ | oral cannabidiol capsule formulati | NDA | 66% | – | 160d |
| Apr 23 | PHVS | Deucrictibant IR | NDA | 66% | – | 167d |
| Apr 28 | IMNM | Varegacestat — adults with desmoid tumors and assigned a PDUF | NDA | 63% | – | 172d |
PDUFA dates in May 2027 (7)
| Date | Ticker | Drug / Indication | Type | Approval odds | Implied move | Countdown |
|---|---|---|---|---|---|---|
| May 1 | AXSM | AXS-12 — cataplexy in narcolepsy | NDA | 66% | – | 175d |
| May 1 | QURE | ifezuntirgene inilparvovec — Huntington's disease | BLA | 47% | – | 175d |
| May 8 | BBIO | encaleret — ADH1 | NDA | 66% | – | 182d |
| May 13 | BMY | Mezigdomide | NDA | 66% | – | 187d |
| May 27 | ZBIO | Obexelimab — IgG4-RD | BLA | 64% | – | 201d |
| May 28 | ETON | KHINDIVI | NDA | 66% | – | 202d |
| May 30 | BMRN | VOXZOGO — hypochondroplasia (HCH) | NDA | 66% | – | 204d |
PDUFA dates in June 2027 (2)
No upcoming FDA decision matches your search. Past decisions are in the PDUFA history.
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