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VERSION:2.0
PRODID:-//Catalyst Calendar//CN-US Event Research//ZH
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:Catalyst Calendar
X-WR-CALDESC:Market-moving event research, reminders and post-event review.
BEGIN:VEVENT
UID:evt-fda-capricor-deramiocel-adcom-pdufa-2026@catalyst-calendar.local
DTSTAMP:20260720T200530Z
DTSTART:20260729T120000Z
DTEND:20260729T123000Z
SUMMARY:FDA审评Capricor deramiocel DMD心肌病BLA的咨询委员会与PDUFA窗口
DESCRIPTION:FDA细胞、组织和基因治疗咨询委员会将于2026年7月29日讨论Capricor deramiocel用于Duchenne肌营养不良心肌病的BLA，申请仍处于审评中，PDUFA目标日期为2026年8月22日。\\nImpact score: 72\\nExpected: 咨询委员会投票、FDA简报和后续PDUFA决定将影响细胞治疗、罕见病和DMD治疗开发风险偏好。\\nAffected: CAPR(subject\, unknown\, score 95)\; SRPT(peer\, mixed\, score 62)\; XBI(etf\, mixed\, score 58)\; RGNX(peer\, mixed\, score 52)\; RARE(peer\, mixed\, score 52)\; IBB(etf\, mixed\, score 45)\\nSources: Capricor advisory committee press release: https://www.capricor.com/investors/news-events/press-releases/detail/348/capricor-therapeutics-announces-fda-advisory-committee\\nCapricor new PDUFA date: https://www.capricor.com/investors/news-events/press-releases/detail/338/capricor-therapeutics-announces-establishment-of-new-pdufa\\nSEC 8-K Capricor: https://www.sec.gov/Archives/edgar/data/1133869/000110465926025657/capr-20260310x8k.htm\\nFDA CTGTAC July 29 2026 meeting announcement: https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-july-29-2026-meeting-announcement-07292026\\nFederal Register notice: https://www.federalregister.gov/documents/2026/06/29/2026-13096/cellular-tissue-and-gene-therapies-advisory-committee-notice-of-meeting-establishment-of-a-public\\nFDA advisory committee calendar: https://www.fda.gov/advisory-committees/advisory-committee-calendar\\nCapricor Q1 2026 8-K exhibit: https://www.sec.gov/Archives/edgar/data/1133869/000110465926059380/capr-20260512xex99d1.htm\\nInformation only. Not investment advice.
URL:https://0.0.0.0:3000/?event=evt-fda-capricor-deramiocel-adcom-pdufa-2026
CATEGORIES:fda\,US\,FDA\,AdCom\,PDUFA\,DMD\,细胞治疗\,cell therapy\,advisory committee\,CTGTAC\,advisory-committee\,cell-therapy
SEQUENCE:0
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ACTION:DISPLAY
DESCRIPTION:Review catalyst preview: FDA审评Capricor deramiocel DMD心肌病BLA的咨询委员会与PDUFA窗口
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TRIGGER:PT24H
ACTION:DISPLAY
DESCRIPTION:Complete post-event review: FDA审评Capricor deramiocel DMD心肌病BLA的咨询委员会与PDUFA窗口
END:VALARM
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