Biopharma Transcript

PDUFA calendar

32 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.

October 2026

  1. October 30
    Inovio Pharmaceuticals, Inc. INO
    INO-3107 — FDA PDUFA action date for BLA (accelerated approval review)In December 2025, the FDA accepted our BLA for INO-3107 for review under the accelerated approval program as a potential treatment for adults with RRP and set the Prescription Drug User Fee Act (PDUFA) target date for October 30, 2026.

November 2026

  1. During November
    Alnylam Pharmaceuticals, Inc. ALNY
    cemdisiran (Regeneron) — FDA target action date for NDA in generalized myasthenia gravisRegeneron filed a New Drug Application, or NDA, for cemdisiran monotherapy with the FDA, which was accepted for review in June 2026 with a target action date of November 2026, following use of a Priority Review Voucher.
  2. During November
    PolyPid Ltd. PYPD
    D-PLEX100 — D-PLEX100 NDA under FDA Priority Review with November 28, 2026 PDUFA goal date.The U.S. Food and Drug Administration has accepted PolyPid's NDA for D-PLEX₁₀₀ and granted Priority Review, with a PDUFA goal date of November 28, 2026.
  3. 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.
  4. 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.
  5. 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.
  6. November 30
    Zai Lab Ltd 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. December 3
    Exelixis, Inc. EXEL
    zanzalintinib + atezolizumab (CRC) — FDA PDUFA target action dateIn February 2026, we announced that the FDA had accepted our NDA and assigned a standard review, with a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.
  2. December 12
    Vanda Pharmaceuticals Inc. VNDA
    Quimilza — FDA PDUFA action date for BLAPDUFA target action date of December 12, 2026
  3. December 23
    Gilead Sciences, Inc. GILD
    anito-cel — FDA action on BLA (PDUFA)target action date of December 23, 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.

January 2027

  1. January 6
    ImmunityBio, Inc. IBRX
    ANKTIVA sBLA (papillary NMIBC) — FDA PDUFA target action dateassigned a PDUFA target action date of January 6, 2027
  2. January 21
    Dyne Therapeutics, Inc. DYN
    z-rostudirsen — FDA action on BLA (PDUFA target date)The FDA has granted the BLA priority review and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of January 21, 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. During February
    Apnimed, Inc. APMD
    AD109 (Oxnimbi) — PDUFA goal date for NDA reviewThe FDA review cycle is targeted to be 10-months from our NDA submission in April 2026, and the FDA has issued a Prescription Drug User Fee Act ('PDUFA') goal date of February 28, 2027
  2. During February
    Cullinan Therapeutics, Inc. CGEM
    zipalertinib monotherapy — NDA seeking accelerated approval for zipalertinib monotherapy in second-line EGFR exon 20 insertion NSCLC remains under FDA review with PDUFA target action date of February 27, 2027.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.
  3. During February
    Cullinan Therapeutics, Inc. CGEM
    zipalertinib monotherapy — NDA for zipalertinib monotherapy in previously treated EGFR ex20ins NSCLC remains under FDA review with a PDUFA action date of February 27, 2027.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.
  4. February 2
    Gilead Sciences, Inc. GILD
    lenacapavir weekly oral — FDA action on sNDA (PDUFA)PDUFA") target action date of February 2, 2027
  5. 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
  6. 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
  7. 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.
  8. February 28
    Biomarin Pharmaceutical Inc BMRN
    VOXZOGO — PDUFA target action date for sNDA (full approval, achondroplasia)In July 2026, we announced that the FDA accepted our 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.

March 2027

  1. March 11
    Bristol Myers Squibb Co BMY
    Reblozyl — PDUFA date, sBLA for MF-associated anemiaThe FDA granted a PDUFA date of March 11, 2027.
  2. 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. April 1
    Harmony Biosciences Holdings, Inc. HRMY
    Pitolisant GR — FDA PDUFA target action 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 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. May 1
    Axsome Therapeutics, Inc. AXSM
    AXS-12 — FDA action on NDA (PDUFA)The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
  2. During May
    BridgeBio Pharma, Inc. BBIO
    encaleret — FDA action on ADH1 NDAPDUFA target 2027-05-08 (per 10-Q)
  3. May 13
    Bristol Myers Squibb Co BMY
    mezigdomide — PDUFA date, NDA for MeziKd in RRMMThe FDA has granted a PDUFA date of May 13, 2027 for this indication.