USFDAJun 26, 2026, 10:03 AM
Capricor FDA Advisory Committee Meeting Set for July 29 for Deramiocel
AI Summary
Capricor Therapeutics announced that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee will convene on July 29, 2026, to discuss the company's Biologics License Application (BLA) for Deramiocel. The BLA, seeking approval for the treatment of Duchenne muscular dystrophy (DMD), remains on track for its PDUFA target action date of August 22, 2026. The application is supported by positive data from the Phase 2 HOPE-2 and HOPE-2-OLE trials, as well as the Phase 3 HOPE-3 trial, which met its primary and key secondary endpoints.
Key Highlights
- FDA Advisory Committee meeting for Deramiocel scheduled for July 29, 2026.
- Biologics License Application (BLA) on track with PDUFA target action date of August 22, 2026.
- Deramiocel is an investigational cell therapy for Duchenne muscular dystrophy (DMD).
- BLA supported by Phase 2 HOPE-2 and HOPE-2-OLE trials, and positive Phase 3 HOPE-3 results.
- HOPE-3 trial achieved statistical significance on primary endpoint (PUL v2.0) and key cardiac endpoint (LVEF).
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