41 upcoming PDUFA target action dates. Each one is pulled straight from the company's own SEC filing and comes with the exact sentence and a link, so you can check it yourself. Updated daily (2026-10-29).
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| PDUFA date | Ticker | Company | Source sentence | Filing |
|---|---|---|---|---|
| 2026-10-30 | INO | INOVIO PHARMACEUTICALS, INC. | the FDA's continued review of our BLA for INO-3107 toward a PDUFA target action date of October 30, 2026; | SEC 2026-08-12 |
| 2026-11-01 | AGIO | AGIOS PHARMACEUTICALS, INC. | The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026. | SEC 2026-07-30 |
| 2026-11-14 | BTAI | BioXcel Therapeutics, Inc. | The FDA has assigned a PDUFA target action date of November 14, 2026, which, if approved, would represent the first FDA-approved treatment option for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting. | SEC 2026-05-15 |
| 2026-11-14 | CYTK | CYTOKINETICS INC | Food and Drug Administration (FDA) with a PDUFA date of November 14, 2026. | SEC 2026-05-05 |
| 2026-11-14 | SMMT | Summit Therapeutics Inc. | the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026. | SEC 2026-09-29 |
| 2026-11-22 | CAPR | CAPRICOR THERAPEUTICS, INC. | EX-99.1 2 capr-20260824xex99d1.htm EX-99.1 Exhibit 99.1 Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA – New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indi | SEC 2026-08-24 |
| 2026-11-27 | BBIO | BridgeBio Pharma, Inc. | The Company’s approved medicine, Attruby, is available to people with transthyretin amyloid cardiomyopathy, and the Company has three additional medicines under FDA review, each for a genetic condition with limited or no approved treatment options: BBP-418 for limb-girdle muscular dystrophy type 2I/R9, or LGMD2I/R9 (PD | SEC 2026-08-31 |
| 2026-11-27 | RPRX | Royalty Pharma plc | In May 2026, Nuvalent announced the FDA accepted its NDA for neladalkib for filing and granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) date of November 27, 2026. | SEC 2026-08-05 |
| 2026-11-30 | COGT | Cogent Biosciences, Inc. | Anticipated Upcoming Milestones • Potential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026 • Potential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026 • Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor, | SEC 2026-08-10 |
| 2026-11-30 | VRTX | VERTEX PHARMACEUTICALS INC / MA | FDA accepted the BLA submission for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026. | SEC 2026-08-03 |
| 2026-11-30 | ZLAB | Zai Lab Ltd | • Povetacicept (pove, APRIL/BAFF): In June 2026, Zai Lab partner Vertex announced that the FDA accepted its BLA submission for pove for accelerated approval in adults with immunoglobulin A nephropathy (IgAN), with a PDUFA target action date of November 30, 2026. | SEC 2026-08-06 |
| 2026-12-03 | EXEL | EXELIXIS, INC. | The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026. | SEC 2026-08-05 |
| 2026-12-12 | VNDA | Vanda Pharmaceuticals Inc. | • The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. | SEC 2026-10-28 |
| 2026-12-21 | JAGX | Jaguar Health, Inc. | Napo (or its designee) shall serve as sponsor and maintain all regulatory filings and Regulatory Approvals for the Canalevia Product until the expiration of the current Regulatory Approval on December 21, 2026 and shall be solely responsible for (and obligated to timely pay) any applicable fees assessed by any Governme | SEC 2026-01-15 |
| 2026-12-22 | MLYS | Mineralys Therapeutics, Inc. | • Commercial Launch Readiness — The Company continues to advance commercial launch preparations ahead of lorundrostat’s PDUFA target date of December 22, 2026 and remains on track. | SEC 2026-08-11 |
| 2026-12-23 | ACLX | Arcellx, Inc. | Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026. | SEC 2026-02-23 |
| 2026-12-23 | GILD | GILEAD SCIENCES, INC. | • Announced that the Biologics License Application for anito-cel in 4L+ R/R MM has been accepted by FDA, with a PDUFA target action date of December 23, 2026. | SEC 2026-05-07 |
| 2026-12-27 | PRAX | Praxis Precision Medicines, Inc. | • Following the submission of additional sensitivity analyses of existing clinical data, which the FDA deemed collectively to be a major amendment, the FDA extended the review period for relutrigine’s NDA for the treatment of SCN2A and SCN8A DEEs and set a new PDUFA target action date of December 27, 2026. | SEC 2026-08-06 |
| 2026-12-27 | VTRS | Viatris Inc | in May, the Company announced that the FDA accepted for review the New Drug Application for MR-107A-02 (fast-acting meloxicam), a non-opioid, for the treatment of moderate-to-severe acute pain and the FDA has assigned a PDUFA goal date of December 27, 2026; | SEC 2026-08-06 |
| 2027-01-21 | DYN | Dyne Therapeutics, Inc. | Key milestones for z-rostudirsen • Dyne’s BLA was accepted for review by the FDA in July 2026, with Priority Review granted (Prescription Drug User Fee Act (PDUFA) target action date set for January 21, 2027). | SEC 2026-07-29 |
| 2027-01-29 | PRAX | Praxis Precision Medicines, Inc. | • NDA review is progressing as expected, with a PDUFA date of January 29, 2027. | SEC 2026-08-06 |
| 2027-02-04 | BBIO | BridgeBio Pharma, Inc. | that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, including by the FDA’s February 4, 2027 PDUFA target action date, or may require additional data, studies or other information; | SEC 2026-10-13 |
| 2027-02-23 | ARQT | Arcutis Biotherapeutics, Inc. | • The FDA accepted an sNDA for ZORYVE cream 0.05% to expand the indication for the treatment of mild to moderate atopic dermatitis in infants aged 3 to 24 months with a Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2027. | SEC 2026-08-05 |
| 2027-02-27 | CGEM | Cullinan Therapeutics, Inc. | An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027. | SEC 2026-10-02 |
| 2027-02-28 | APMD | Apnimed, Inc. | Apnimed's NDA for Oxnimbi is under review by the FDA and was assigned a PDUFA goal date of February 28, 2027. | SEC 2026-09-08 |
| 2027-02-28 | BMRN | BIOMARIN PHARMACEUTICAL INC | • In July, BioMarin announced that the FDA accepted its sNDA for full approval of VOXZOGO in children with achondroplasia, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027. | SEC 2026-08-06 |
| 2027-02-28 | PVLA | PALVELLA THERAPEUTICS, INC. | With compelling Phase 3 SELVA results and a February 28, 2027 PDUFA target action date, we believe we are closer than ever to delivering on that mission. | SEC 2026-10-28 |
| 2027-03-10 | NTLA | Intellia Therapeutics, Inc. | Food and Drug Administration (“FDA”) has accepted the Biologics License Application (“BLA”) for lonvoguran ziclumeran (“lonvo-z”) and granted the BLA Priority Review with a Prescription Drug User Fee Act (“PDUFA”) target action date of March 10, 2027. | SEC 2026-09-08 |
| 2027-03-11 | BMY | BRISTOL MYERS SQUIBB CO | The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027. | SEC 2026-07-30 |
| 2027-03-16 | AQST | Aquestive Therapeutics, Inc. | Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027 | SEC 2026-10-15 |
| 2027-03-29 | AQST | Aquestive Therapeutics, Inc. | The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027. | SEC 2026-10-14 |
| 2027-03-29 | ETON | Eton Pharmaceuticals, Inc. | The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027. | SEC 2026-10-14 |
| 2027-04-01 | HRMY | Harmony Biosciences Holdings, Inc. | PITOLISANT GR – NDA ACCEPTED FOR FULL REVIEW PDUFA date anticipated April 1, 2027 PITOLISANT HD – ONGOING PHASE 3 REGISTRATIONAL STUDIES IN NARCOLEPSY AND IH TLD expected in 2027; | SEC 2026-08-04 |
| 2027-04-14 | INBX | Inhibrx Biosciences, Inc. | Food and Drug Administration (FDA) accepted for filing the Company’s biologics license application (BLA) for the potential approval of ozekibart in conventional chondrosarcoma and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 14, 2027. | SEC 2026-08-13 |
| 2027-04-23 | RPRX | Royalty Pharma plc | deucrictibant In July 2026, Pharvaris announced that the FDA accepted its NDA for deucrictibant immediate-release for the on-demand treatment of hereditary angioedema attacks and assigned a PDUFA date of April 23, 2027. | SEC 2026-08-05 |
| 2027-04-28 | IMNM | Immunome Inc. | FDA accepted Immunome’s NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027. | SEC 2026-08-11 |
| 2027-05-01 | AXSM | Axsome Therapeutics, Inc. | 4 Anticipated Milestones • Clinical Trial Initiations and Progress: o Phase 2/3 trial of AXS-05 in smoking cessation, initiation (3Q 2026) • Clinical Trial Topline Results: o Phase 3 ENGAGE trial of solriamfetol in binge eating disorder (4Q 2026) o Phase 3 SUSTAIN trial of solriamfetol in shift work disorder (2027) • R | SEC 2026-08-10 |
| 2027-05-07 | BBIO | BridgeBio Pharma, Inc. | encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027); | SEC 2026-08-31 |
| 2027-05-08 | BBIO | BridgeBio Pharma, Inc. | • The FDA re-considered its review designation of the Company's NDA filing for encaleret in ADH1 and has granted Priority Review, with a PDUFA target action date of May 8, 2027. | SEC 2026-08-10 |
| 2027-05-13 | BMY | BRISTOL MYERS SQUIBB CO | mezigdomide July 13 The FDA accepted a New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) in patients with relapsed or refractory multiple myeloma (RRMM), granting a PDUFA date of May 13, 2027. | SEC 2026-07-30 |
| 2027-05-27 | ZBIO | Zenas BioPharma, Inc. | Food and Drug Administration (FDA) accepted the Company’s Biologics License Application (BLA) for obexelimab for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD): The BLA has a Prescription Drug User Fee Act (PDUFA) target action date of May 27, 2027. | SEC 2026-08-13 |
Informational data from public SEC EDGAR filings. Not investment advice. Not affiliated with the FDA or SEC. Dates can change, so always check the linked filing.
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