BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//Breakaway//FDA calendar//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:FDA calendar (Breakaway)
X-WR-CALDESC:PDUFA dates and FDA advisory committee meetings drug companies
  have announced\, from Breakaway's FDA calendar.
REFRESH-INTERVAL;VALUE=DURATION:PT12H
X-PUBLISHED-TTL:PT12H
BEGIN:VEVENT
UID:pdufa-INO-20261030@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261030
DTEND;VALUE=DATE:20261031
SUMMARY:INO: FDA decision date (PDUFA)\, INO-3107 (Approved)
DESCRIPTION:Inovio Pharmaceuticals: the date the company announced for the 
 FDA's decision on INO-3107. The FDA can act earlier or extend its review. 
 Approved.\nhttps://getbreakaway.com/biotech/INO-ino-3107
URL:https://getbreakaway.com/biotech/INO-ino-3107
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-AGIO-20261101@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261101
DTEND;VALUE=DATE:20261102
SUMMARY:AGIO: FDA decision date (PDUFA)\, Mitapivat (No decision announced 
 yet)
DESCRIPTION:Agios Pharmaceuticals: the date the company announced for the F
 DA's decision on Mitapivat. The FDA can act earlier or extend its review. 
 No decision announced yet.\nhttps://getbreakaway.com/biotech/AGIO-mitapiva
 t
URL:https://getbreakaway.com/biotech/AGIO-mitapivat
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-NRXP-20261110@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261110
DTEND;VALUE=DATE:20261111
SUMMARY:NRXP: FDA goal date\, generic drug (GDUFA)\, Preservative-free keta
 mine (Approved)
DESCRIPTION:NRX Pharmaceuticals: the date the company announced for the FDA
 's decision on Preservative-free ketamine. The FDA can act earlier or exte
 nd its review. Approved.\nhttps://getbreakaway.com/biotech/NRXP-preservati
 ve-free-ketamine
URL:https://getbreakaway.com/biotech/NRXP-preservative-free-ketamine
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-CYTK-20261114@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261114
DTEND;VALUE=DATE:20261115
SUMMARY:CYTK: FDA decision date (PDUFA)\, Aficamten
DESCRIPTION:Cytokinetics: the date the company announced for the FDA's deci
 sion on Aficamten. The FDA can act earlier or extend its review.\nhttps://
 getbreakaway.com/biotech/CYTK-aficamten
URL:https://getbreakaway.com/biotech/CYTK-aficamten
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-SMMT-20261114@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261114
DTEND;VALUE=DATE:20261115
SUMMARY:SMMT: FDA decision date (PDUFA)\, Ivonescimab
DESCRIPTION:Summit Therapeutics: the date the company announced for the FDA
 's decision on Ivonescimab. The FDA can act earlier or extend its review.\
 nhttps://getbreakaway.com/biotech/SMMT-ivonescimab
URL:https://getbreakaway.com/biotech/SMMT-ivonescimab
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-CAPR-20261122@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261122
DTEND;VALUE=DATE:20261123
SUMMARY:CAPR: FDA decision date (PDUFA)\, Deramiocel (Delayed from undefine
 d 20\, Aug )
DESCRIPTION:Capricor Therapeutics: the date the company announced for the F
 DA's decision on Deramiocel. The FDA can act earlier or extend its review.
  Delayed from undefined 20\, Aug .\nhttps://getbreakaway.com/biotech/CAPR-
 deramiocel
URL:https://getbreakaway.com/biotech/CAPR-deramiocel
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-SVRA-20261122@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261122
DTEND;VALUE=DATE:20261123
SUMMARY:SVRA: FDA decision date (PDUFA)\, Molgramostim
DESCRIPTION:Savara: the date the company announced for the FDA's decision o
 n Molgramostim. The FDA can act earlier or extend its review.\nhttps://get
 breakaway.com/biotech/SVRA-molgramostim
URL:https://getbreakaway.com/biotech/SVRA-molgramostim
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-SNY-20261125@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261125
DTEND;VALUE=DATE:20261126
SUMMARY:SNY: FDA decision date (PDUFA)\, Venglustat
DESCRIPTION:Sanofi: the date the company announced for the FDA's decision o
 n Venglustat. The FDA can act earlier or extend its review.\nhttps://getbr
 eakaway.com/biotech/SNY-venglustat
URL:https://getbreakaway.com/biotech/SNY-venglustat
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-BBIO-20261127@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261127
DTEND;VALUE=DATE:20261128
SUMMARY:BBIO: FDA decision date (PDUFA)\, BBP-418
DESCRIPTION:BridgeBio Pharma: the date the company announced for the FDA's 
 decision on BBP-418. The FDA can act earlier or extend its review.\nhttps:
 //getbreakaway.com/biotech/BBIO-bbp-418
URL:https://getbreakaway.com/biotech/BBIO-bbp-418
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-COGT-20261130@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261130
DTEND;VALUE=DATE:20261201
SUMMARY:COGT: FDA decision date (PDUFA)\, Bezuclastinib
DESCRIPTION:Cogent Biosciences: the date the company announced for the FDA'
 s decision on Bezuclastinib. The FDA can act earlier or extend its review.
 \nhttps://getbreakaway.com/biotech/COGT-bezuclastinib-gist
URL:https://getbreakaway.com/biotech/COGT-bezuclastinib-gist
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-VRTX-20261130@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261130
DTEND;VALUE=DATE:20261201
SUMMARY:VRTX: FDA decision date (PDUFA)\, Povetacicept
DESCRIPTION:Vertex Pharmaceuticals: the date the company announced for the 
 FDA's decision on Povetacicept. The FDA can act earlier or extend its revi
 ew.\nhttps://getbreakaway.com/biotech/VRTX-povetacicept
URL:https://getbreakaway.com/biotech/VRTX-povetacicept
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-VNDA-20261212@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261212
DTEND;VALUE=DATE:20261213
SUMMARY:VNDA: FDA decision date (PDUFA)
DESCRIPTION:Vanda Pharmaceuticals: the date the company announced for the F
 DA's decision. The FDA can act earlier or extend its review.\nhttps://getb
 reakaway.com/stocks/VNDA
URL:https://getbreakaway.com/stocks/VNDA
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-CORT-20261217@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261217
DTEND;VALUE=DATE:20261218
SUMMARY:CORT: FDA decision date (PDUFA)\, Relacorilant
DESCRIPTION:Corcept Therapeutics: the date the company announced for the FD
 A's decision on Relacorilant. The FDA can act earlier or extend its review
 .\nhttps://getbreakaway.com/biotech/CORT-relacorilant
URL:https://getbreakaway.com/biotech/CORT-relacorilant
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-MLYS-20261222@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261222
DTEND;VALUE=DATE:20261223
SUMMARY:MLYS: FDA decision date (PDUFA)\, Lorundrostat
DESCRIPTION:Mineralys Therapeutics: the date the company announced for the 
 FDA's decision on Lorundrostat. The FDA can act earlier or extend its revi
 ew.\nhttps://getbreakaway.com/biotech/MLYS-lorundrostat
URL:https://getbreakaway.com/biotech/MLYS-lorundrostat
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-PRAX-20261227@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261227
DTEND;VALUE=DATE:20261228
SUMMARY:PRAX: FDA decision date (PDUFA)\, Relutrigine
DESCRIPTION:Praxis Precision Medicines: the date the company announced for 
 the FDA's decision on Relutrigine. The FDA can act earlier or extend its r
 eview.\nhttps://getbreakaway.com/biotech/PRAX-relutrigine
URL:https://getbreakaway.com/biotech/PRAX-relutrigine
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-VTRS-20261227@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261227
DTEND;VALUE=DATE:20261228
SUMMARY:VTRS: FDA decision date (PDUFA)\, MR-107A-02
DESCRIPTION:Viatris: the date the company announced for the FDA's decision 
 on MR-107A-02. The FDA can act earlier or extend its review.\nhttps://getb
 reakaway.com/biotech/VTRS-mr-107a-02
URL:https://getbreakaway.com/biotech/VTRS-mr-107a-02
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-COGT-20261230@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20261230
DTEND;VALUE=DATE:20261231
SUMMARY:COGT: FDA decision date (PDUFA)\, Bezuclastinib
DESCRIPTION:Cogent Biosciences: the date the company announced for the FDA'
 s decision on Bezuclastinib. The FDA can act earlier or extend its review.
 \nhttps://getbreakaway.com/biotech/COGT-bezuclastinib-nonadvsm
URL:https://getbreakaway.com/biotech/COGT-bezuclastinib-nonadvsm
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-NUVB-20270104@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20270104
DTEND;VALUE=DATE:20270105
SUMMARY:NUVB: FDA decision date (PDUFA)\, Taletrectinib
DESCRIPTION:Nuvation Bio: the date the company announced for the FDA's deci
 sion on Taletrectinib. The FDA can act earlier or extend its review.\nhttp
 s://getbreakaway.com/biotech/NUVB-taletrectinib
URL:https://getbreakaway.com/biotech/NUVB-taletrectinib
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-IBRX-20270106@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20270106
DTEND;VALUE=DATE:20270107
SUMMARY:IBRX: FDA decision date (PDUFA)\, Anktiva
DESCRIPTION:ImmunityBio: the date the company announced for the FDA's decis
 ion on Anktiva. The FDA can act earlier or extend its review.\nhttps://get
 breakaway.com/biotech/IBRX-anktiva
URL:https://getbreakaway.com/biotech/IBRX-anktiva
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-DYN-20270121@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20270121
DTEND;VALUE=DATE:20270122
SUMMARY:DYN: FDA decision date (PDUFA)
DESCRIPTION:Dyne Therapeutics: the date the company announced for the FDA's
  decision. The FDA can act earlier or extend its review.\nhttps://getbreak
 away.com/stocks/DYN
URL:https://getbreakaway.com/stocks/DYN
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-INSM-20270128@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20270128
DTEND;VALUE=DATE:20270129
SUMMARY:INSM: FDA decision date (PDUFA)
DESCRIPTION:Insmed: the date the company announced for the FDA's decision. 
 The FDA can act earlier or extend its review.\nhttps://getbreakaway.com/st
 ocks/INSM
URL:https://getbreakaway.com/stocks/INSM
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-PRAX-20270129@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20270129
DTEND;VALUE=DATE:20270130
SUMMARY:PRAX: FDA decision date (PDUFA)
DESCRIPTION:Praxis Precision Medicines: the date the company announced for 
 the FDA's decision. The FDA can act earlier or extend its review.\nhttps:/
 /getbreakaway.com/stocks/PRAX
URL:https://getbreakaway.com/stocks/PRAX
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:pdufa-PHAR-20270130@getbreakaway.com
DTSTAMP:20261103T013052Z
DTSTART;VALUE=DATE:20270130
DTEND;VALUE=DATE:20270131
SUMMARY:PHAR: FDA decision date (PDUFA)
DESCRIPTION:Pharming: the date the company announced for the FDA's decision
 . The FDA can act earlier or extend its review.\nhttps://getbreakaway.com/
 biotech
URL:https://getbreakaway.com/biotech
TRANSP:TRANSPARENT
END:VEVENT
END:VCALENDAR