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PRODID:-//FreeBioList//EN
CALSCALE:GREGORIAN
X-WR-CALNAME:FreeBioList
BEGIN:VEVENT
UID:RARE-20260919@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20260919
SUMMARY:RARE — UX111 PDUFA date
DESCRIPTION:Ultragenyx Pharmaceutical: UX111 for Sanfilippo syndrome type A (MPS IIIA). Source: https://www.marketbeat.com/fda-calendar/upcoming/
URL:https://www.marketbeat.com/fda-calendar/upcoming/
END:VEVENT
BEGIN:VEVENT
UID:MIRM-20260926@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20260926
SUMMARY:MIRM — Zilurgisertib PDUFA date
DESCRIPTION:Mirum Pharmaceuticals: Zilurgisertib for Fibrodysplasia ossificans progressiva (FOP). Source: https://www.sec.gov/Archives/edgar/data/1759425/000175942526000044/mirm-20260805xexx991.htm
URL:https://www.sec.gov/Archives/edgar/data/1759425/000175942526000044/mirm-20260805xexx991.htm
END:VEVENT
BEGIN:VEVENT
UID:SXTP-20261006@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261006
SUMMARY:SXTP — Tafenoquine Clinical readout
DESCRIPTION:60 Degrees Pharmaceuticals: Tafenoquine for Babesiosis (interim analysis). Source: https://www.sec.gov/Archives/edgar/data/1946563/000121390026098056/ea030486201ex99-1.htm
URL:https://www.sec.gov/Archives/edgar/data/1946563/000121390026098056/ea030486201ex99-1.htm
END:VEVENT
BEGIN:VEVENT
UID:MRK-20261010@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261010
SUMMARY:MRK — Ifinatamab deruxtecan (I-DXd) PDUFA date
DESCRIPTION:Merck & Co.: Ifinatamab deruxtecan (I-DXd) for Small cell lung cancer. Source: https://www.marketbeat.com/fda-calendar/upcoming/
URL:https://www.marketbeat.com/fda-calendar/upcoming/
END:VEVENT
BEGIN:VEVENT
UID:IONS-20261026@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261026
SUMMARY:IONS — Bepirovirsen PDUFA date
DESCRIPTION:Ionis Pharmaceuticals: Bepirovirsen for Chronic hepatitis B. Source: https://www.sec.gov/Archives/edgar/data/874015/000114036126029960/ef20078953_ex99-1.htm
URL:https://www.sec.gov/Archives/edgar/data/874015/000114036126029960/ef20078953_ex99-1.htm
END:VEVENT
BEGIN:VEVENT
UID:INO-20261030@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261030
SUMMARY:INO — INO-3107 PDUFA date
DESCRIPTION:Inovio Pharmaceuticals: INO-3107 for Recurrent respiratory papillomatosis (RRP). Source: https://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htm
URL:https://www.sec.gov/Archives/edgar/data/1055726/000105572626000024/ino-63026x8kex991.htm
END:VEVENT
BEGIN:VEVENT
UID:CYTK-20261114@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261114
SUMMARY:CYTK — Aficamten PDUFA date
DESCRIPTION:Cytokinetics: Aficamten for Hypertrophic cardiomyopathy (MAPLE-HCM sNDA). Source: https://www.sec.gov/Archives/edgar/data/1061983/000119312526206360/cytk-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1061983/000119312526206360/cytk-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:SVRA-20261122@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261122
SUMMARY:SVRA — Molgramostim PDUFA date
DESCRIPTION:Savara Inc.: Molgramostim for Autoimmune pulmonary alveolar proteinosis (aPAP). Source: https://www.marketbeat.com/fda-calendar/upcoming/
URL:https://www.marketbeat.com/fda-calendar/upcoming/
END:VEVENT
BEGIN:VEVENT
UID:CAPR-20261122@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261122
SUMMARY:CAPR — Deramiocel PDUFA date (extended)
DESCRIPTION:Capricor Therapeutics: Deramiocel for Duchenne muscular dystrophy cardiomyopathy. Source: https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htm
URL:https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824xex99d1.htm
END:VEVENT
BEGIN:VEVENT
UID:BBIO-20261127@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261127
SUMMARY:BBIO — BBP-418 PDUFA date
DESCRIPTION:BridgeBio Pharma: BBP-418 for Limb-girdle muscular dystrophy type 2I/R9. Source: https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm
URL:https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm
END:VEVENT
BEGIN:VEVENT
UID:PYPD-20261128@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261128
SUMMARY:PYPD — D-PLEX100 PDUFA date
DESCRIPTION:PolyPid Ltd.: D-PLEX100 for Prevention of surgical site infection in abdominal colorectal surgery. Source: https://www.sec.gov/Archives/edgar/data/1611842/000121390026082564/ea029964201ex99-1.htm
URL:https://www.sec.gov/Archives/edgar/data/1611842/000121390026082564/ea029964201ex99-1.htm
END:VEVENT
BEGIN:VEVENT
UID:COGT-20261130@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261130
SUMMARY:COGT — Bezuclastinib PDUFA date
DESCRIPTION:Cogent Biosciences: Bezuclastinib for Gastrointestinal stromal tumour (GIST). Source: https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:ZLAB-20261130@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261130
SUMMARY:ZLAB — Povetacicept PDUFA date
DESCRIPTION:Zai Lab Ltd.: Povetacicept for IgA nephropathy. Source: https://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htm
URL:https://www.sec.gov/Archives/edgar/data/1704292/000162828026053791/zlab-202686x8kex991.htm
END:VEVENT
BEGIN:VEVENT
UID:VNDA-20261212@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261212
SUMMARY:VNDA — Quimilza (imsidolimab) PDUFA date
DESCRIPTION:Vanda Pharmaceuticals: Quimilza (imsidolimab) for Generalised pustular psoriasis. Source: https://www.sec.gov/Archives/edgar/data/1347178/000162828026053308/vnda8-k852026exhibit991.htm
URL:https://www.sec.gov/Archives/edgar/data/1347178/000162828026053308/vnda8-k852026exhibit991.htm
END:VEVENT
BEGIN:VEVENT
UID:CORT-20261217@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261217
SUMMARY:CORT — Relacorilant FDA decision expected
DESCRIPTION:Corcept Therapeutics: Relacorilant for Cushing's syndrome. Source: https://www.sec.gov/Archives/edgar/data/1088856/000162828026050607/cort072926ex991pressrelease.htm
URL:https://www.sec.gov/Archives/edgar/data/1088856/000162828026050607/cort072926ex991pressrelease.htm
END:VEVENT
BEGIN:VEVENT
UID:PRAX-20261227@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261227
SUMMARY:PRAX — Relutrigine PDUFA date (extended)
DESCRIPTION:Praxis Precision Medicines: Relutrigine for SCN2A and SCN8A developmental epileptic encephalopathies. Source: https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm
URL:https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm
END:VEVENT
BEGIN:VEVENT
UID:COGT-20261230@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20261230
SUMMARY:COGT — Bezuclastinib PDUFA date
DESCRIPTION:Cogent Biosciences: Bezuclastinib for Non-advanced systemic mastocytosis. Source: https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1622229/000119312526341315/cogt-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:IBRX-20270106@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270106
SUMMARY:IBRX — ANKTIVA (nogapendekin alfa) plus BCG PDUFA date
DESCRIPTION:ImmunityBio: ANKTIVA (nogapendekin alfa) plus BCG for BCG-unresponsive NMIBC with papillary disease. Source: https://www.sec.gov/Archives/edgar/data/1326110/000132611026000077/ibrx-202684x8kexhibit991.htm
URL:https://www.sec.gov/Archives/edgar/data/1326110/000132611026000077/ibrx-202684x8kexhibit991.htm
END:VEVENT
BEGIN:VEVENT
UID:DYN-20270121@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270121
SUMMARY:DYN — z-rostudirsen (DYNE-251) PDUFA date
DESCRIPTION:Dyne Therapeutics: z-rostudirsen (DYNE-251) for Duchenne muscular dystrophy, exon 51 skipping. Source: https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1818794/000119312526323940/dyn-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:PRAX-20270129@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270129
SUMMARY:PRAX — Ulixacaltamide PDUFA date
DESCRIPTION:Praxis Precision Medicines: Ulixacaltamide for Essential tremor. Source: https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm
URL:https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/praxisq22026pr.htm
END:VEVENT
BEGIN:VEVENT
UID:BLTE-20270212@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270212
SUMMARY:BLTE — Tinlarebant PDUFA date
DESCRIPTION:Belite Bio: Tinlarebant for Stargardt disease type 1. Source: https://www.sec.gov/Archives/edgar/data/1889109/000110465926105608/tm2624806d1_ex99-1.htm
URL:https://www.sec.gov/Archives/edgar/data/1889109/000110465926105608/tm2624806d1_ex99-1.htm
END:VEVENT
BEGIN:VEVENT
UID:ARQT-20270223@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270223
SUMMARY:ARQT — ZORYVE (roflumilast) cream 0.05% PDUFA date
DESCRIPTION:Arcutis Biotherapeutics: ZORYVE (roflumilast) cream 0.05% for Atopic dermatitis in infants aged 3–24 months. Source: https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htm
URL:https://www.sec.gov/Archives/edgar/data/1787306/000178730626000049/pressreleaseex991q22026.htm
END:VEVENT
BEGIN:VEVENT
UID:CGEM-20270227@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270227
SUMMARY:CGEM — Zipalertinib PDUFA date
DESCRIPTION:Cullinan Therapeutics: Zipalertinib for EGFR exon 20 insertion NSCLC, second line. Source: https://www.sec.gov/Archives/edgar/data/1789972/000119312526336700/cgem-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1789972/000119312526336700/cgem-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:APMD-20270228@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270228
SUMMARY:APMD — AD109 (Oxnimbi) PDUFA date
DESCRIPTION:Apnimed: AD109 (Oxnimbi) for Obstructive sleep apnoea in adults. Source: https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1745648/000119312526385355/apmd-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:NTLA-20270310@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270310
SUMMARY:NTLA — Lonvoguran ziclumeran (lonvo-z) PDUFA date
DESCRIPTION:Intellia Therapeutics: Lonvoguran ziclumeran (lonvo-z) for Hereditary angioedema (HAE). Source: https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:HRMY-20270401@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270401
SUMMARY:HRMY — Pitolisant GR PDUFA date
DESCRIPTION:Harmony Biosciences Holdings: Pitolisant GR for Narcolepsy. Source: https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d1.htm
URL:https://www.sec.gov/Archives/edgar/data/1802665/000110465926090086/hrmy-20260804xex99d1.htm
END:VEVENT
BEGIN:VEVENT
UID:PHVS-20270423@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270423
SUMMARY:PHVS — Deucrictibant IR PDUFA date
DESCRIPTION:Pharvaris N.V.: Deucrictibant IR for Hereditary angioedema, on-demand treatment. Source: https://www.sec.gov/Archives/edgar/data/1830487/000119312526345702/phvs-ex99_2.htm
URL:https://www.sec.gov/Archives/edgar/data/1830487/000119312526345702/phvs-ex99_2.htm
END:VEVENT
BEGIN:VEVENT
UID:IMNM-20270428@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270428
SUMMARY:IMNM — Varegacestat PDUFA date
DESCRIPTION:Immunome: Varegacestat for Desmoid tumours. Source: https://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1472012/000119312526344577/imnm-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:AXSM-20270501@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270501
SUMMARY:AXSM — AXS-12 (reboxetine) PDUFA date
DESCRIPTION:Axsome Therapeutics: AXS-12 (reboxetine) for Cataplexy in narcolepsy. Source: https://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htm
URL:https://www.sec.gov/Archives/edgar/data/1579428/000119312526341206/axsm-ex99_1.htm
END:VEVENT
BEGIN:VEVENT
UID:BBIO-20270508@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270508
SUMMARY:BBIO — Encaleret PDUFA date
DESCRIPTION:BridgeBio Pharma: Encaleret for Autosomal dominant hypocalcaemia type 1 (ADH1). Source: https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm
URL:https://www.sec.gov/Archives/edgar/data/1743881/000174388126000026/bbio-20260630xex991.htm
END:VEVENT
BEGIN:VEVENT
UID:ZBIO-20270527@catalysts
DTSTAMP:20261007T201826Z
DTSTART;VALUE=DATE:20270527
SUMMARY:ZBIO — Obexelimab PDUFA date
DESCRIPTION:Zenas BioPharma: Obexelimab for Immunoglobulin G4-related disease (IgG4-RD). Source: https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htm
URL:https://www.sec.gov/Archives/edgar/data/1953926/000110465926095437/tm2622871d1_ex99-1.htm
END:VEVENT
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