Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
Deramiocel has the potential to become the first therapy to address both skeletal and cardiac manifestations of Duchenne muscular dystrophyBLA supported by positive pivotal HOPE-3 Phase 3 results, including achievement of the primary endpoint and all Type I error-controlled secondary endpointsPDUFA target action date set for August 22, 2026; Company expects to be eligible for a Priority Review Voucher upon potential approval SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel, an investigational cell therapy, for the treatment of Duchenne muscular dystrophy (“DMD”) cardiomyopathy. The submission has been class
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News
- Capricor Therapeutics (CAPR) had its "buy" rating reaffirmed by HC Wainwright. They now have a $60.00 price target on the stock.MarketBeat
- Capricor extends rally as FDA to review rejected cell therapy [Seeking Alpha]Seeking Alpha
- Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics to Present Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Update on March 12 [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics to Present Fourth Quarter and Full Year 2025 Financial Results and Recent Corporate Update on March 12GlobeNewswire
CAPR
Earnings
- 11/10/25 - In-Line
CAPR
Sec Filings
- 3/10/26 - Form 8-K
- 2/26/26 - Form SCHEDULE
- 2/17/26 - Form SCHEDULE
- CAPR's page on the SEC website