Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: GlobeNewswire
FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophyFDA advised Capricor to request a meeting to determine next steps toward potential approvalConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the Company’s lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In the CRL, the FDA stated that it had completed its review of the application but is u
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News
- Capricor Therapeutics, Inc. (CAPR): A Bear Case Theory [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar Highlighting Positive Phase 3 HOPE-3 Topline Results in Duchenne Muscular DystrophyGlobeNewswire
- Capricor Therapeutics (NASDAQ:CAPR) was given a new $50.00 price target on by analysts at UBS Group AG.MarketBeat
- Capricor Therapeutics (NASDAQ:CAPR) had its "buy" rating reaffirmed by analysts at B. Riley.MarketBeat
- Capricor: A Detailed Examination Of Hope-3 [Seeking Alpha]Seeking Alpha
CAPR
Earnings
- 11/10/25 - In-Line
CAPR
Sec Filings
- 12/5/25 - Form 424B5
- 12/5/25 - Form 8-K
- 12/5/25 - Form 424B3
- CAPR's page on the SEC website