Biopharma Transcript

PDUFA calendar

52 upcoming FDA action dates disclosed by listed companies, each with the sentence from the filing that states it. Dates are as the company reported them; the FDA can act early or extend a review.

November 2026

  1. During November
    Alnylam Pharmaceuticals, Inc. ALNY
    cemdisiran monotherapy for myasthenia gravis — FDA action dateNDA ... accepted for review in June 2026 with a target action date of November 2026
  2. During November
    Regeneron Pharmaceuticals, Inc. REGN
    Cemdisiran — FDA decision on New Drug Application for gMGFDA decision on New Drug Application (NDA) (November 2026) and EC decision on MAA (second half 2027) for gMG
  3. November 14
    Cytokinetics Inc CYTK
    MYQORZO (aficamten) — PDUFA date for sNDA adding MAPLE-HCM results to labelThe FDA assigned a standard review classification to the sNDA with a PDUFA date of November 14, 2026.
  4. November 14
    Summit Therapeutics Inc. SMMT
    ivonescimab (HARMONi) — FDA PDUFA goal action date for BLAThe FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
  5. November 22
    Capricor Therapeutics, Inc. CAPR
    deramiocel — FDA PDUFA target action date for BLA (extended from Aug 22)Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel ... from August 22, 2026 to November 22, 2026.
  6. November 22
    Savara Inc SVRA
    MOLBREEVI — FDA PDUFA target action date for BLA (extended after a major amendment)The FDA determined that the Company's responses to recent information requests by the Agency during their review constituted a major amendment to the BLA, resulting in a three-month extension of the Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026.
  7. November 25
    Sanofi SNY
    venglustat — FDA target action date for venglustat NDA in Gaucher disease type 3 (priority review)The target action date for the FDA decision is November 25, 2026.
  8. November 27
    BridgeBio Pharma, Inc. BBIO
    BBP-418 — PDUFA target action dateThe FDA accepted our NDA for filing, granted Priority Review and assigned a Prescription Drug User Fee Act ("PDUFA") target action date of November 27, 2026, for BBP-418.
  9. November 27
    Royalty Pharma plc RPRX
    Neladalkib (Nuvalent/GSK; royalty-funded candidate) — FDA PDUFA date (licensee-sponsored)In May 2026, Nuvalent announced the FDA accepted its NDA for neladalkib for filing and granted the application Priority Review with a PDUFA date of November 27, 2026.
  10. November 28
    PolyPid Ltd. PYPD
    D-PLEX100 — D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date.D-PLEX₁₀₀ NDA concurrently under FDA Priority Review with November 28, 2026 PDUFA goal date
  11. November 30
    Cogent Biosciences, Inc. COGT
    Bezuclastinib + sunitinib (GIST) — PDUFA target action datePotential FDA approval of bezuclastinib in GIST – PDUFA date of November 30, 2026
  12. November 30
    Vertex Pharmaceuticals Incorporated VRTX
    povetacicept — FDA PDUFA action date for accelerated approval in IgANThe FDA accepted our biologics license application for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.
  13. November 30
    Zai Lab Limited ZLAB
    Povetacicept (partner Vertex) — FDA PDUFA action date for accelerated approval BLA in IgANthe FDA accepted its BLA submission for pove for accelerated approval in adults with IgAN, with a PDUFA target action date of November 30, 2026

December 2026

  1. During December
    Corcept Therapeutics Inc CORT
    Relacorilant for hypercortisolism — FDA PDUFA decisionThe Prescription Drug User Fee Act target date for the FDA to complete its review is December 17, 2026.
  2. During December
    Mineralys Therapeutics, Inc. MLYS
    Lorundrostat — FDA PDUFA action date for NDAFDA accepted the NDA with a PDUFA target action date of December 22, 2026.
  3. During December
    Vanda Pharmaceuticals Inc. VNDA
    Quimilza (imsidolimab) — PDUFA target action dateThe 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.
  4. December 27
    Praxis Precision Medicines, Inc. PRAX
    relutrigine — PDUFA action date (NDA, priority review, extended three months)In June 2026, the FDA notified us that it had extended by three months the review period for our NDA for relutrigine, setting an updated PDUFA action date of December 27, 2026.
  5. December 30
    Cogent Biosciences, Inc. COGT
    Bezuclastinib (NonAdvSM) — PDUFA target action datePotential FDA approval of bezuclastinib in NonAdvSM – PDUFA date of December 30, 2026

January 2027

  1. During January
    Dyne Therapeutics, Inc. DYN
    z-rostudirsen — PDUFA target action dateThe FDA has granted the BLA priority review and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of January 21, 2027.
  2. January 28
    INSMED Inc INSM
    ARIKAYCE — US sNDA for MAC lung disease - priority review target action dateIn September 2026, our US supplemental new drug application (sNDA) for ARIKAYCE in patients with MAC lung disease was accepted and granted priority review by the FDA as part of a combination antibacterial drug regimen, with a target action date of January 28, 2027.
  3. January 29
    Praxis Precision Medicines, Inc. PRAX
    ulixacaltamide — PDUFA action date (NDA)it was accepted for review with a target action date under the Prescription Drug User Fee Act, or PDUFA, of January 29, 2027.

February 2027

  1. February 1
    Agios Pharmaceuticals, Inc. AGIO
    mitapivat (SCD) — PDUFA goal date for sNDA in SCDThe PDUFA goal date was subsequently extended to February 1, 2027 following our response to an FDA information request to inform its evaluation as to whether a REMS is necessary for mitapivat in SCD.
  2. During February
    BioMarin Pharmaceutical Inc. BMRN
    VOXZOGO — PDUFA target action date for full approval in achondroplasiathe FDA accepted our sNDA for full approval of VOXZOGO in children with achondroplasia, with a PDUFA target action date of February 28, 2027
  3. During February
    Ligand Pharmaceuticals Inc LGND
    Qtorin rapamycin (Palvella) — PDUFA target action date for NDA in microcystic lymphatic malformationsThe FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.
  4. During February
    Palvella Therapeutics, Inc. PVLA
    QTORIN rapamycin for microcystic LMs — FDA PDUFA action dateThe FDA assigned a Prescription Drug User Fee Act ('PDUFA') target action date of February 28, 2027.
  5. During February
    Regeneron Pharmaceuticals, Inc. REGN
    Ordspono (odronextamab) — FDA decision on BLA for relapsed/refractory DLBCLFDA decision on BLA for relapsed/refractory DLBCL (February 2027)
  6. During February
    Sarepta Therapeutics, Inc. SRPT
    VYONDYS 53 and AMONDYS 45 — PDUFA target action date for sNDAsAs of the date of this Quarterly Report, we anticipate a PDUFA target action date of February 28, 2027.
  7. February 4
    BridgeBio Pharma, Inc. BBIO
    Infigratinib — PDUFA target action dateThe FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of February 4, 2027, for infigratinib.
  8. February 12
    Belite Bio, Inc BLTE
    Tinlarebant (STGD1) — FDA PDUFA target action date (NDA with Priority Review)U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) with Priority Review for tinlarebant for the treatment of Stargardt disease type 1 (STGD1); Prescription Drug User Fee Act (PDUFA) target action date of February 12, 2027
  9. February 18
    Argenx SE ARGX
    VYVGART (efgartigimod alfa-fcab) — argenx disclosed a PDUFA date of February 18, 2027 for VYVGART in ocular MG.Ocular MG PDUFA date of February 18, 2027
  10. February 23
    Arcutis Biotherapeutics, Inc. ARQT
    ZORYVE cream 0.05% (infants 3 months to <2 years, atopic dermatitis) — FDA PDUFA action on sNDAWe submitted a Supplemental New Drug Application (sNDA) to the FDA based on the results of this trial to potentially expand the indication for ZORYVE cream 0.05% for the treatment of infants with atopic dermatitis down to the age of 3 months, which has been assigned a Prescription Drug User Fee Act (PDUFA) target actio
  11. February 27
    Cullinan Therapeutics, Inc. CGEM
    zipalertinib — FDA PDUFA target action date for NDAThe U.S. FDA assigned a Prescription Drug User Fee Act target action date of February 27, 2027.
  12. February 28
    Apnimed, Inc. APMD
    AD109 (Oxnimbi) — FDA PDUFA goal action date for NDAthe FDA has issued a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2027, although the duration of the review may vary based on various factors.

March 2027

  1. During March
    Aquestive Therapeutics, Inc. AQST
    Libervant — PDUFA goal date for patients twelve years of age and olderFinal FDA approval for patients twelve years of age and older is subject to expiration of the orphan drug exclusivity for Valtoco® on January 10, 2027, and final FDA action, with a PDUFA goal date of March 23, 2027.
  2. During March
    Exelixis, Inc. EXEL
    zanzalintinib + atezolizumab — PDUFA target action date for NDA in metastatic colorectal cancerThe updated PDUFA target action date is March 3, 2027.
  3. During March
    Intellia Therapeutics, Inc. NTLA
    lonvoguran ziclumeran (lonvo-z) — PDUFA target action dateIn September 2026, the FDA accepted the BLA for lonvo-z and granted the BLA Priority Review with a Prescription Drug User Fee Act ('PDUFA') target action date of March 10, 2027.
  4. During March
    Regeneron Pharmaceuticals, Inc. REGN
    Libtayo (cemiplimab) — FDA decision on supplemental Biologics License Application for every 6-week dosing regimenFDA decision on supplemental Biologics License Application (sBLA) (March 2027) and EC decision on regulatory submission (fourth quarter 2026) for every 6-week dosing regimen for approved indications
  5. March 29
    Eton Pharmaceuticals, Inc. ETON
    LIBERVANT (diazepam buccal film) — Type 9 NDA for LIBERVANT ages 6-11 expansion has PDUFA target action date of March 29, 2027.The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.

April 2027

  1. During April
    Harmony Biosciences Holdings, Inc. HRMY
    Pitolisant GR — PDUFA target dateIn June 2026, we submitted a New Drug Application ("NDA") for Pitolisant GR to the FDA, which was subsequently accepted for full review with a target Prescription Drug User Fee Act ("PDUFA") date of April 1, 2027.
  2. April 23
    Pharvaris N.V. PHVS
    Deucrictibant IR — FDA PDUFA action date for on-demand HAE NDAIn July 2026, the U.S. Food and Drug Administration (FDA) accepted to review the Company's New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks, with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027.
  3. April 23
    Royalty Pharma plc RPRX
    Deucrictibant (Pharvaris; royalty-funded candidate) — FDA PDUFA date (licensee-sponsored)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.
  4. April 24
    Organogenesis Holdings Inc. ORGO
    ReNu — PDUFA target action dateDuring June 2026, the FDA accepted the BLA for review and assigned a PDUFA target action date of April 24, 2027.
  5. April 26
    UNITED THERAPEUTICS Corp UTHR
    Nebulized Tyvaso IPF — FDA action date (sNDA)In September 2026, we were notified that the FDA had accepted our sNDA with a user fee goal date of April 26, 2027.
  6. April 28
    Immunome Inc. IMNM
    varegacestat — FDA PDUFA target action date for NDAassigned a Prescription Drug User Fee Act, or PDUFA, target action date of April 28, 2027

May 2027

  1. During May
    Axsome Therapeutics, Inc. AXSM
    AXS-12 — PDUFA target action dateThe FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
  2. During May
    BioMarin Pharmaceutical Inc. BMRN
    VOXZOGO — PDUFA target action date for hypochondroplasia sNDAthe U.S. Food and Drug Administration (FDA) set a Prescription Drug User Fee Act (PDUFA) target action date of May 30, 2027 for supplemental new drug application (sNDA) to expand the use of VOXZOGO for the treatment of hypochondroplasia (HCH)
  3. During May
    Zenas BioPharma ZBIO
    obexelimab (IgG4-RD) — PDUFA target dateIn August 2026, the FDA accepted our BLA and assigned a Prescription Drug User Fee Act ('PDUFA') target date of May 27, 2027.
  4. During May
    uniQure N.V. QURE
    ifezuntirgene inilparvovec (AMT-130) — PDUFA target action dateThe application has been granted Priority Review with a Prescription Drug User Fee Act ("PDUFA") target action date of May 1, 2027.
  5. May 8
    BridgeBio Pharma, Inc. BBIO
    Encaleret — PDUFA target action dateThe FDA accepted our NDA for filing, granted Priority Review and assigned a PDUFA target action date of May 8, 2027, for encaleret.

June 2027

  1. During June
    Cogent Biosciences, Inc. COGT
    bezuclastinib (AdvSM) — PDUFA action dateThe FDA assigned a PDUFA target action date of June 29, 2027.
  2. During June
    UroGen Pharma Ltd. URGN
    UGN-103 — PDUFA target action dateIn October 2026, we announced the FDA's acceptance of the NDA and the assignment of a Prescription Drug User Fee Act ('PDUFA') target action date of June 14, 2027.
  3. June 24
    UNITED THERAPEUTICS Corp UTHR
    Ralinepag extended-release tablets — FDA action date (NDA)In August 2026, we were notified that the FDA had accepted our NDA and established a user fee goal date of June 24, 2027.