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Why Is Capricor Therapeutics Stock Trading Lower On Friday? - Capricor Therapeutics (NASDAQ:CAPR)
UNITED STATES, JUL 11 – FDA cited lack of substantial evidence of effectiveness for Capricor's Duchenne muscular dystrophy cell therapy, prompting requests for more clinical data and delaying approval.
- On Friday, Capricor Therapeutics stock plummeted about 37% after the FDA issued a Complete Response Letter rejecting its BLA for Deramiocel.
- FDA’s complete response letter cited lack of substantial evidence of effectiveness and unresolved manufacturing issues, despite prior smooth review and inspections, prompting the stock decline.
- The FDA cited unresolved CMC issues, despite Capricor passing inspections and responding to over 50 requests, with CEO Marbán calling the decision “a surprise”.
- Investors sold off sharply, with CAPR stock dropping nearly 39% in premarket trading after the FDA rejection.
- Capricor plans to request a Type A meeting with the FDA, with the review clock restarting upon resubmission, and expects Phase 3 HOPE-3 trial results in Q3 2025.
11 Articles
11 Articles
FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease
Capricor Therapeutics said the FDA asked for more data supporting the efficacy of Deramiocel, the biotech’s off-the-shelf cell therapy for treating the heart complications of Duchenne muscular dystrophy. Those data could come from an ongoing Phase 3 study expected to yield preliminary results soon. The post FDA Turns Down Capricor Cell Therapy for Cardio Complications of Rare Muscle Disease appeared first on MedCity News.
Why Is Capricor Therapeutics Stock Trading Lower On Friday? - Capricor Therapeutics (NASDAQ:CAPR)
Capricor Therapeutics Inc. (NASDAQ:CAPR) stock is trading lower on Friday. The company 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 cardiomyopathy associated with Duchenne muscular dystrophy (DMD). In the CRL, the FDA stated that it had completed its application review but could not approve…
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