USFDAJul 30, 2026, 04:09 PM
Capricor's Deramiocel Not Supported by FDA Panel Vote
AI Summary
Capricor Therapeutics announced that the FDA's Cellular, Tissue and Gene Therapies Advisory Committee voted against the effectiveness of Deramiocel for cardiomyopathy in Duchenne muscular dystrophy patients (3 for, 9 against). While the recommendation is non-binding, the FDA will consider it in its ongoing review of the Biologics License Application (BLA). The PDUFA target action date remains August 22, 2026, and Capricor remains committed to the therapy.
Key Highlights
- FDA Advisory Committee voted 9-3 against Deramiocel's effectiveness for DMD cardiomyopathy.
- The Committee's recommendation is non-binding for the FDA's BLA review.
- FDA's PDUFA target action date for Deramiocel BLA remains August 22, 2026.
- Capricor Therapeutics remains committed to Deramiocel and confident in HOPE-3 data.
- Committee's discussion on upper limb function was directionally supportive.
Price Impact
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