FDA Schedules Advisory Committee Meeting for Deramiocel BLA Review on July 29
Summary
Capricor Therapeutics announced that the FDA has scheduled an Advisory Committee meeting for July 29, 2026, to review its Biologics License Application for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy.
Key Events
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FDA Advisory Committee Meeting Scheduled
The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) will convene on July 29, 2026, to review the Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD).
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PDUFA Date Confirmed
The BLA for Deramiocel remains on track for its Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026.
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Positive Clinical Data Supports BLA
The BLA is supported by positive results from Phase 2 HOPE-2, HOPE-2-OLE, and Phase 3 HOPE-3 trials, which demonstrated statistically significant skeletal and cardiac benefits.
Analysis
The FDA Advisory Committee meeting is a critical public review step for Capricor's lead drug, Deramiocel, ahead of its August 22 PDUFA date. The committee's discussion and recommendations will heavily influence the FDA's final decision on approval, making this a high-stakes event for the company's future, especially given the ongoing lawsuit regarding the drug's commercialization.
At the time of this filing, CAPR was trading at $26.55 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.5B. The 52-week trading range was $4.30 to $40.37. This filing was assessed with neutral market sentiment and an importance score of 8 out of 10.