[
 {
  "ticker": "INO",
  "company": "INOVIO PHARMACEUTICALS, INC.",
  "cik": "1055726",
  "pdufaDate": "2026-10-30",
  "pdufaDateText": "October 30, 2026",
  "dateIsExact": true,
  "evidenceQuote": "the FDA's continued review of our BLA for INO-3107 toward a PDUFA target action date of October 30, 2026;",
  "formType": "8-K",
  "filedAt": "2026-08-12",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htm"
 },
 {
  "ticker": "AGIO",
  "company": "AGIOS PHARMACEUTICALS, INC.",
  "cik": "1439222",
  "pdufaDate": "2026-11-01",
  "pdufaDateText": "November 1, 2026",
  "dateIsExact": true,
  "evidenceQuote": "The Prescription Drug User Fee Act (PDUFA) goal date for this sNDA, submitted under the FDA\u2019s accelerated approval pathway, is November 1, 2026.",
  "formType": "8-K",
  "filedAt": "2026-07-30",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1439222/000143922226000115/agio-73026xfyxex991earning.htm"
 },
 {
  "ticker": "BTAI",
  "company": "BioXcel Therapeutics, Inc.",
  "cik": "1720893",
  "pdufaDate": "2026-11-14",
  "pdufaDateText": "November 14, 2026",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-05-15",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1720893/000110465926061773/tm2614679d1_ex99-1.htm"
 },
 {
  "ticker": "CYTK",
  "company": "CYTOKINETICS INC",
  "cik": "1061983",
  "pdufaDate": "2026-11-14",
  "pdufaDateText": "November 14, 2026",
  "dateIsExact": true,
  "evidenceQuote": "Food and Drug Administration (FDA) with a PDUFA date of November 14, 2026.",
  "formType": "8-K",
  "filedAt": "2026-05-05",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1061983/000119312526206360/cytk-ex99_1.htm"
 },
 {
  "ticker": "SMMT",
  "company": "Summit Therapeutics Inc.",
  "cik": "1599298",
  "pdufaDate": "2026-11-14",
  "pdufaDateText": "November 14, 2026",
  "dateIsExact": true,
  "evidenceQuote": "the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.",
  "formType": "8-K",
  "filedAt": "2026-09-29",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1599298/000119312526405776/d178892dex991.htm"
 },
 {
  "ticker": "CAPR",
  "company": "CAPRICOR THERAPEUTICS, INC.",
  "cik": "1133869",
  "pdufaDate": "2026-11-22",
  "pdufaDateText": "November 22, 2026",
  "dateIsExact": true,
  "evidenceQuote": "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 \u2013 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 \u2013 SAN DIEGO , Aug.",
  "formType": "8-K",
  "filedAt": "2026-08-24",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htm"
 },
 {
  "ticker": "BBIO",
  "company": "BridgeBio Pharma, Inc.",
  "cik": "1743881",
  "pdufaDate": "2026-11-27",
  "pdufaDateText": "November 27, 2026",
  "dateIsExact": true,
  "evidenceQuote": "The Company\u2019s 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);",
  "formType": "8-K",
  "filedAt": "2026-08-31",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htm"
 },
 {
  "ticker": "RPRX",
  "company": "Royalty Pharma plc",
  "cik": "1802768",
  "pdufaDate": "2026-11-27",
  "pdufaDateText": "November 27, 2026",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-08-05",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htm"
 },
 {
  "ticker": "COGT",
  "company": "Cogent Biosciences, Inc.",
  "cik": "1622229",
  "pdufaDate": "2026-11-30",
  "pdufaDateText": "November 30, 2026",
  "dateIsExact": true,
  "evidenceQuote": "Anticipated Upcoming Milestones \u2022 Potential FDA approval of bezuclastinib in GIST \u2013 PDUFA date of November 30, 2026 \u2022 Potential FDA approval of bezuclastinib in NonAdvSM \u2013 PDUFA date of December 30, 2026 \u2022 Submit Investigational New Drug (IND) applications for CGT1815, Cogent\u2019s novel, selective pan-KRAS(ON) inhibitor, and CGT1145, Cogent\u2019s novel, selective JAK2 V617F inhibitor \u2022 Complete dose escalation for CGT4255, Cogent\u2019s CNS-penetrant, selective mutant ErbB2 inhibitor Second Quarter 2026 Financial Results Cash Position: As of June 30, 2026, Cogent had cash, cash equivalents and marketable ",
  "formType": "8-K",
  "filedAt": "2026-08-10",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm"
 },
 {
  "ticker": "VRTX",
  "company": "VERTEX PHARMACEUTICALS INC / MA",
  "cik": "875320",
  "pdufaDate": "2026-11-30",
  "pdufaDateText": "November 30, 2026",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-08-03",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/875320/000087532026000256/ex-991_q22026.htm"
 },
 {
  "ticker": "ZLAB",
  "company": "Zai Lab Ltd",
  "cik": "1704292",
  "pdufaDate": "2026-11-30",
  "pdufaDateText": "November 30, 2026",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 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.",
  "formType": "8-K",
  "filedAt": "2026-08-06",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htm"
 },
 {
  "ticker": "EXEL",
  "company": "EXELIXIS, INC.",
  "cik": "939767",
  "pdufaDate": "2026-12-03",
  "pdufaDateText": "December 3, 2026",
  "dateIsExact": true,
  "evidenceQuote": "The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 3, 2026.",
  "formType": "8-K",
  "filedAt": "2026-08-05",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/939767/000093976726000096/exel20260630exhibit991.htm"
 },
 {
  "ticker": "VNDA",
  "company": "Vanda Pharmaceuticals Inc.",
  "cik": "1347178",
  "pdufaDate": "2026-12-12",
  "pdufaDateText": "December 12, 2026",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 The Biologics License Application (BLA) for Quimilza\u2122 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.",
  "formType": "8-K",
  "filedAt": "2026-10-28",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1347178/000162828026067886/vnda8-k10282026exhibit991.htm"
 },
 {
  "ticker": "JAGX",
  "company": "Jaguar Health, Inc.",
  "cik": "1585608",
  "pdufaDate": "2026-12-21",
  "pdufaDateText": "December 21, 2026",
  "dateIsExact": true,
  "evidenceQuote": "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 Government Authority for any Regulatory Approval (e.g., any Prescription Drug User Fee Act (PDUFA) fees)) necessary for the Licensee to sell, offer for sale, have sold, promote, distribute and otherwise commercialize the Mytesi Product in the Field in the Territory during the Term.",
  "formType": "8-K",
  "filedAt": "2026-01-15",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1585608/000119312526014231/jagx-ex10_1.htm"
 },
 {
  "ticker": "MLYS",
  "company": "Mineralys Therapeutics, Inc.",
  "cik": "1933414",
  "pdufaDate": "2026-12-22",
  "pdufaDateText": "December 22, 2026",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 Commercial Launch Readiness \u2014 The Company continues to advance commercial launch preparations ahead of lorundrostat\u2019s PDUFA target date of December 22, 2026 and remains on track.",
  "formType": "8-K",
  "filedAt": "2026-08-11",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1933414/000193341426000112/mlys2026q28kex991.htm"
 },
 {
  "ticker": "ACLX",
  "company": "Arcellx, Inc.",
  "cik": "1786205",
  "pdufaDate": "2026-12-23",
  "pdufaDateText": "December 23, 2026",
  "dateIsExact": true,
  "evidenceQuote": "Food and Drug Administration with an anticipated Prescription Drug User Fee Act (PDUFA) action date of December 23, 2026.",
  "formType": "8-K",
  "filedAt": "2026-02-23",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1786205/000119312526063955/d112937dex991.htm"
 },
 {
  "ticker": "GILD",
  "company": "GILEAD SCIENCES, INC.",
  "cik": "882095",
  "pdufaDate": "2026-12-23",
  "pdufaDateText": "December 23, 2026",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 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.",
  "formType": "8-K",
  "filedAt": "2026-05-07",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/882095/000088209526000022/exhibit991earningspressrel.htm"
 },
 {
  "ticker": "PRAX",
  "company": "Praxis Precision Medicines, Inc.",
  "cik": "1689548",
  "pdufaDate": "2026-12-27",
  "pdufaDateText": "December 27, 2026",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 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\u2019s NDA for the treatment of SCN2A and SCN8A DEEs and set a new PDUFA target action date of December 27, 2026.",
  "formType": "8-K",
  "filedAt": "2026-08-06",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm"
 },
 {
  "ticker": "VTRS",
  "company": "Viatris Inc",
  "cik": "1792044",
  "pdufaDate": "2026-12-27",
  "pdufaDateText": "December 27, 2026",
  "dateIsExact": true,
  "evidenceQuote": "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;",
  "formType": "8-K",
  "filedAt": "2026-08-06",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1792044/000179204426000037/exhibit991-2q26earningsrel.htm"
 },
 {
  "ticker": "DYN",
  "company": "Dyne Therapeutics, Inc.",
  "cik": "1818794",
  "pdufaDate": "2027-01-21",
  "pdufaDateText": "January 21, 2027",
  "dateIsExact": true,
  "evidenceQuote": "Key milestones for z-rostudirsen \u2022 Dyne\u2019s 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).",
  "formType": "8-K",
  "filedAt": "2026-07-29",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htm"
 },
 {
  "ticker": "PRAX",
  "company": "Praxis Precision Medicines, Inc.",
  "cik": "1689548",
  "pdufaDate": "2027-01-29",
  "pdufaDateText": "January 29, 2027",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 NDA review is progressing as expected, with a PDUFA date of January 29, 2027.",
  "formType": "8-K",
  "filedAt": "2026-08-06",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm"
 },
 {
  "ticker": "BBIO",
  "company": "BridgeBio Pharma, Inc.",
  "cik": "1743881",
  "pdufaDate": "2027-02-04",
  "pdufaDateText": "February 4, 2027",
  "dateIsExact": true,
  "evidenceQuote": "that the FDA, EMA or other regulatory authorities may not approve oral infigratinib on the anticipated timeline or at all, including by the FDA\u2019s February 4, 2027 PDUFA target action date, or may require additional data, studies or other information;",
  "formType": "8-K",
  "filedAt": "2026-10-13",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_ex99-1.htm"
 },
 {
  "ticker": "ARQT",
  "company": "Arcutis Biotherapeutics, Inc.",
  "cik": "1787306",
  "pdufaDate": "2027-02-23",
  "pdufaDateText": "February 23, 2027",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 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.",
  "formType": "8-K",
  "filedAt": "2026-08-05",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htm"
 },
 {
  "ticker": "CGEM",
  "company": "Cullinan Therapeutics, Inc.",
  "cik": "1789972",
  "pdufaDate": "2027-02-27",
  "pdufaDateText": "February 27, 2027",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-10-02",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1789972/000119312526411011/cgem-ex99_1.htm"
 },
 {
  "ticker": "APMD",
  "company": "Apnimed, Inc.",
  "cik": "1745648",
  "pdufaDate": "2027-02-28",
  "pdufaDateText": "February 28, 2027",
  "dateIsExact": true,
  "evidenceQuote": "Apnimed's NDA for Oxnimbi is under review by the FDA and was assigned a PDUFA goal date of February 28, 2027.",
  "formType": "8-K",
  "filedAt": "2026-09-08",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htm"
 },
 {
  "ticker": "BMRN",
  "company": "BIOMARIN PHARMACEUTICAL INC",
  "cik": "1048477",
  "pdufaDate": "2027-02-28",
  "pdufaDateText": "February 28, 2027",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 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.",
  "formType": "8-K",
  "filedAt": "2026-08-06",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1048477/000104847726000015/earningsrelease-6aug26ex991.htm"
 },
 {
  "ticker": "PVLA",
  "company": "PALVELLA THERAPEUTICS, INC.",
  "cik": "1583648",
  "pdufaDate": "2027-02-28",
  "pdufaDateText": "February 28, 2027",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-10-28",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1583648/000119312526435113/pvla-ex99_1.htm"
 },
 {
  "ticker": "NTLA",
  "company": "Intellia Therapeutics, Inc.",
  "cik": "1652130",
  "pdufaDate": "2027-03-10",
  "pdufaDateText": "March 10, 2027",
  "dateIsExact": true,
  "evidenceQuote": "Food and Drug Administration (\u201cFDA\u201d) has accepted the Biologics License Application (\u201cBLA\u201d) for lonvoguran ziclumeran (\u201clonvo-z\u201d) and granted the BLA Priority Review with a Prescription Drug User Fee Act (\u201cPDUFA\u201d) target action date of March 10, 2027.",
  "formType": "8-K",
  "filedAt": "2026-09-08",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-20260908.htm"
 },
 {
  "ticker": "BMY",
  "company": "BRISTOL MYERS SQUIBB CO",
  "cik": "14272",
  "pdufaDate": "2027-03-11",
  "pdufaDateText": "March 11, 2027",
  "dateIsExact": true,
  "evidenceQuote": "The FDA granted a Prescription Drug User Fee Act (PDUFA) date of March 11, 2027.",
  "formType": "8-K",
  "filedAt": "2026-07-30",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htm"
 },
 {
  "ticker": "AQST",
  "company": "Aquestive Therapeutics, Inc.",
  "cik": "1398733",
  "pdufaDate": "2027-03-16",
  "pdufaDateText": "March 16, 2027",
  "dateIsExact": true,
  "evidenceQuote": "Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm\u2122 (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.",
  "formType": "8-K",
  "filedAt": "2026-10-15",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/aqst-20261015.htm"
 },
 {
  "ticker": "AQST",
  "company": "Aquestive Therapeutics, Inc.",
  "cik": "1398733",
  "pdufaDate": "2027-03-29",
  "pdufaDateText": "March 29, 2027",
  "dateIsExact": true,
  "evidenceQuote": "The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.",
  "formType": "8-K",
  "filedAt": "2026-10-14",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1398733/000139873326000056/etonaquestivelibervantpr.htm"
 },
 {
  "ticker": "ETON",
  "company": "Eton Pharmaceuticals, Inc.",
  "cik": "1710340",
  "pdufaDate": "2027-03-29",
  "pdufaDateText": "March 29, 2027",
  "dateIsExact": true,
  "evidenceQuote": "The NDA has a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2027.",
  "formType": "8-K",
  "filedAt": "2026-10-14",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1710340/000143774926032600/ex_1025429.htm"
 },
 {
  "ticker": "HRMY",
  "company": "Harmony Biosciences Holdings, Inc.",
  "cik": "1802665",
  "pdufaDate": "2027-04-01",
  "pdufaDateText": "April 1, 2027",
  "dateIsExact": true,
  "evidenceQuote": "PITOLISANT GR \u2013 NDA ACCEPTED FOR FULL REVIEW PDUFA date anticipated April 1, 2027 PITOLISANT HD \u2013 ONGOING PHASE 3 REGISTRATIONAL STUDIES IN NARCOLEPSY AND IH TLD expected in 2027;",
  "formType": "8-K",
  "filedAt": "2026-08-04",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d2.htm"
 },
 {
  "ticker": "INBX",
  "company": "Inhibrx Biosciences, Inc.",
  "cik": "2007919",
  "pdufaDate": "2027-04-14",
  "pdufaDateText": "April 14, 2027",
  "dateIsExact": true,
  "evidenceQuote": "Food and Drug Administration (FDA) accepted for filing the Company\u2019s 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.",
  "formType": "8-K",
  "filedAt": "2026-08-13",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/2007919/000200791926000044/exhibit99106302026.htm"
 },
 {
  "ticker": "RPRX",
  "company": "Royalty Pharma plc",
  "cik": "1802768",
  "pdufaDate": "2027-04-23",
  "pdufaDateText": "April 23, 2027",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-08-05",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htm"
 },
 {
  "ticker": "IMNM",
  "company": "Immunome Inc.",
  "cik": "1472012",
  "pdufaDate": "2027-04-28",
  "pdufaDateText": "April 28, 2027",
  "dateIsExact": true,
  "evidenceQuote": "FDA accepted Immunome\u2019s NDA for varegacestat for the treatment of adults with desmoid tumors and assigned a PDUFA target action date of April 28, 2027.",
  "formType": "8-K",
  "filedAt": "2026-08-11",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htm"
 },
 {
  "ticker": "AXSM",
  "company": "Axsome Therapeutics, Inc.",
  "cik": "1579428",
  "pdufaDate": "2027-05-01",
  "pdufaDateText": "May 1, 2027",
  "dateIsExact": true,
  "evidenceQuote": "4 Anticipated Milestones \u2022 Clinical Trial Initiations and Progress: o Phase 2/3 trial of AXS-05 in smoking cessation, initiation (3Q 2026) \u2022 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) \u2022 Regulatory and Commercial: o AXS-12 for narcolepsy, PDUFA target action (May 1, 2027) Conference Call Information Axsome will host a conference call and webcast today at 8:00 a.m.",
  "formType": "8-K",
  "filedAt": "2026-08-10",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htm"
 },
 {
  "ticker": "BBIO",
  "company": "BridgeBio Pharma, Inc.",
  "cik": "1743881",
  "pdufaDate": "2027-05-07",
  "pdufaDateText": "May 7, 2027",
  "dateIsExact": true,
  "evidenceQuote": "encaleret for autosomal dominant hypocalcemia type 1, or ADH1 (PDUFA date with Priority Review: May 7, 2027);",
  "formType": "8-K",
  "filedAt": "2026-08-31",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1743881/000114036126035055/ef20081330_ex99-1.htm"
 },
 {
  "ticker": "BBIO",
  "company": "BridgeBio Pharma, Inc.",
  "cik": "1743881",
  "pdufaDate": "2027-05-08",
  "pdufaDateText": "May 8, 2027",
  "dateIsExact": true,
  "evidenceQuote": "\u2022 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.",
  "formType": "8-K",
  "filedAt": "2026-08-10",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm"
 },
 {
  "ticker": "BMY",
  "company": "BRISTOL MYERS SQUIBB CO",
  "cik": "14272",
  "pdufaDate": "2027-05-13",
  "pdufaDateText": "May 13, 2027",
  "dateIsExact": true,
  "evidenceQuote": "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.",
  "formType": "8-K",
  "filedAt": "2026-07-30",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/14272/000001427226000018/a2026q2ex991-filing.htm"
 },
 {
  "ticker": "ZBIO",
  "company": "Zenas BioPharma, Inc.",
  "cik": "1953926",
  "pdufaDate": "2027-05-27",
  "pdufaDateText": "May 27, 2027",
  "dateIsExact": true,
  "evidenceQuote": "Food and Drug Administration (FDA) accepted the Company\u2019s 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.",
  "formType": "8-K",
  "filedAt": "2026-08-13",
  "secUrl": "https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htm"
 }
]