PDUFA calendar 2026: FDA goal dates with registered forecasts
This calendar lists the FDA goal dates NextConsensus has registered a forecast on, month by month. Each row gives the drug, the applicant, the FDA review center and the registered probability. Follow a row to its record for the terms that settle it.
A row's probability is the estimate that FDA approves the application by its goal date. It was frozen at registration. A complete response letter, an extension, a withdrawal, no action, or an approval after the date resolves the record NO.
FDA does not publish goal dates, so each date is the one the sponsor or its partner disclosed in a filing. The PDUFA date guide covers where the dates come from and what each outcome means for a plan.
FDA action by goal date: 14 registered · 14 unresolved · 0 resolved. Registry snapshot 2026-10-06.
PDUFA dates in October 2026
| Goal date | Drug and application | Applicant | Reviewed by | Registered probability |
|---|---|---|---|---|
| Bepirovirsen · hepatitis B approvalFF-007 | GSK | FDA · CDER | 84%Unresolved | |
| INO-3107 · papillomatosis approvalFF-010 | Inovio | FDA · CBER | 45%Unresolved |
PDUFA dates in November 2026
| Goal date | Drug and application | Applicant | Reviewed by | Registered probability |
|---|---|---|---|---|
| Mitapivat · sickle cell supplement approvalFF-012 | Agios | FDA · CDER | 72%Unresolved | |
| Aficamten · MAPLE-HCM supplement approvalFF-005 | Cytokinetics | FDA · CDER | 82%Unresolved | |
| IGALMI · at-home supplement approvalFF-009 | BioXcel Therapeutics (applicant at the cutoff) | FDA · CDER | 35%Unresolved | |
| Ivonescimab · post-TKI NSCLC approvalFF-011 | Summit Therapeutics | FDA · CDER | 15%Unresolved | |
| Deramiocel · Duchenne approvalFF-008 | Capricor Therapeutics | FDA · CBER | 35%Unresolved | |
| Molgramostim · aPAP approvalFF-013 | Savara | FDA · CDER | 75%Unresolved | |
| Venglustat · type 3 Gaucher disease approvalFF-027 | Sanofi | FDA · CDER | 75%Unresolved | |
| BBP-418 · muscular dystrophy approvalFF-006 | BridgeBio Pharma | FDA · CDER | 85%Unresolved | |
| Neladalkib · ALK-positive NSCLC approvalFF-025 | Nuvalent (a GSK company since July 2026) | FDA · CDER | 85%Unresolved | |
| D-PLEX100 · colorectal surgical site infection approvalFF-024 | PolyPid | FDA · CDER | 55%Unresolved | |
| Bezuclastinib · GIST approvalFF-023 | Cogent Biosciences | FDA · CDER | 85%Unresolved | |
| Povetacicept · IgA nephropathy approvalFF-026 | Vertex | FDA · CDER | 85%Unresolved |
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
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