https://nidhi-bhai.github.io/pdufa-calendar/Upcoming PDUFA dates from SEC filingshttps://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htmhttps://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htmOctober 30, 2026the FDA's continued review of our BLA for INO-3107 toward a PDUFA target action date of October 30, 2026;https://www.sec.gov/Archives/edgar/data/1439222/000143922226000115/agio-73026xfyxex991earning.htmhttps://www.sec.gov/Archives/edgar/data/1439222/000143922226000115/agio-73026xfyxex991earning.htmNovember 1, 2026The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA’s accelerated approval pathway, is November 1, 2026.https://www.sec.gov/Archives/edgar/data/1720893/000110465926061773/tm2614679d1_ex99-1.htmhttps://www.sec.gov/Archives/edgar/data/1720893/000110465926061773/tm2614679d1_ex99-1.htmNovember 14, 2026The 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.https://www.sec.gov/Archives/edgar/data/1061983/000119312526206360/cytk-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1061983/000119312526206360/cytk-ex99_1.htmNovember 14, 2026Food and Drug Administration (FDA) with a PDUFA date of November 14, 2026.https://www.sec.gov/Archives/edgar/data/1599298/000119312526405776/d178892dex991.htmhttps://www.sec.gov/Archives/edgar/data/1599298/000119312526405776/d178892dex991.htmNovember 14, 2026the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htmhttps://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htmNovember 22, 2026EX-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 indication – SAN DIEGO , Aug.https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htmhttps://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htmNovember 27, 2026The 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 (PDUFA date with Priority Review: November 27, 2026);https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htmhttps://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htmNovember 27, 2026In 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.https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htmNovember 30, 2026Anticipated 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, and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor • Complete dose escahttps://www.sec.gov/Archives/edgar/data/875320/000087532026000256/ex-991_q22026.htmhttps://www.sec.gov/Archives/edgar/data/875320/000087532026000256/ex-991_q22026.htmNovember 30, 2026FDA accepted the BLA submission for accelerated approval of povetacicept for adults with IgAN and assigned a PDUFA target action date of November 30, 2026.https://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htmhttps://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htmNovember 30, 2026• 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.https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htmhttps://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htmDecember 3, 2026The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.https://www.sec.gov/Archives/edgar/data/1347178/000162828026067886/vnda8-k10282026exhibit991.htmhttps://www.sec.gov/Archives/edgar/data/1347178/000162828026067886/vnda8-k10282026exhibit991.htmDecember 12, 2026• 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.https://www.sec.gov/Archives/edgar/data/1585608/000119312526014231/jagx-ex10_1.htmhttps://www.sec.gov/Archives/edgar/data/1585608/000119312526014231/jagx-ex10_1.htmDecember 21, 2026Napo (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 Government Authority for any Regulatory Approval (e.g., any Prescription Drug User Fee Ahttps://www.sec.gov/Archives/edgar/data/1933414/000193341426000112/mlys2026q28kex991.htmhttps://www.sec.gov/Archives/edgar/data/1933414/000193341426000112/mlys2026q28kex991.htmDecember 22, 2026• 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.https://www.sec.gov/Archives/edgar/data/1786205/000119312526063955/d112937dex991.htmhttps://www.sec.gov/Archives/edgar/data/1786205/000119312526063955/d112937dex991.htmDecember 23, 2026Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.https://www.sec.gov/Archives/edgar/data/882095/000088209526000022/exhibit991earningspressrel.htmhttps://www.sec.gov/Archives/edgar/data/882095/000088209526000022/exhibit991earningspressrel.htmDecember 23, 2026• 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.https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htmhttps://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htmDecember 27, 2026• 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.https://www.sec.gov/Archives/edgar/data/1792044/000179204426000037/exhibit991-2q26earningsrel.htmhttps://www.sec.gov/Archives/edgar/data/1792044/000179204426000037/exhibit991-2q26earningsrel.htmDecember 27, 2026in 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;https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htmJanuary 21, 2027Key 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).https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htmhttps://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htmJanuary 29, 2027• NDA review is progressing as expected, with a PDUFA date of January 29, 2027.https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_ex99-1.htmhttps://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_ex99-1.htmFebruary 4, 2027that 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;https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htmhttps://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htmFebruary 23, 2027• 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.https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-ex99_1.htmFebruary 27, 2027An 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.https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htmFebruary 28, 2027Apnimed's NDA for Oxnimbi is under review by the FDA and was assigned a PDUFA goal date of February 28, 2027.https://www.sec.gov/Archives/edgar/data/1048477/000104847726000015/earningsrelease-6aug26ex991.htmhttps://www.sec.gov/Archives/edgar/data/1048477/000104847726000015/earningsrelease-6aug26ex991.htmFebruary 28, 2027• 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.https://www.sec.gov/Archives/edgar/data/1583648/000119312526435113/pvla-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1583648/000119312526435113/pvla-ex99_1.htmFebruary 28, 2027With 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.https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htmhttps://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htmMarch 10, 2027Food 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.https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htmhttps://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htmMarch 11, 2027The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027.https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/aqst-20261015.htmhttps://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/aqst-20261015.htmMarch 16, 2027Food 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.https://www.sec.gov/Archives/edgar/data/1398733/000139873326000056/etonaquestivelibervantpr.htmhttps://www.sec.gov/Archives/edgar/data/1398733/000139873326000056/etonaquestivelibervantpr.htmMarch 29, 2027The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.https://www.sec.gov/Archives/edgar/data/1710340/000143774926032600/ex_1025429.htmhttps://www.sec.gov/Archives/edgar/data/1710340/000143774926032600/ex_1025429.htmMarch 29, 2027The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d2.htmhttps://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d2.htmApril 1, 2027PITOLISANT 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;https://www.sec.gov/Archives/edgar/data/2007919/000200791926000044/exhibit99106302026.htmhttps://www.sec.gov/Archives/edgar/data/2007919/000200791926000044/exhibit99106302026.htmApril 14, 2027Food 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.https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htmhttps://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htmApril 23, 2027deucrictibant 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.https://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htmApril 28, 2027FDA 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.https://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htmhttps://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htmMay 1, 20274 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) • Regulatory and Commercial: o AXS-12 for narcolepsy, PDUFA target action (May 1, 2https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htmhttps://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htmMay 7, 2027encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027);https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htmhttps://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htmMay 8, 2027• 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.https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htmhttps://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htmMay 13, 2027mezigdomide 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.https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htmhttps://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htmMay 27, 2027Food 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.