Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data
Capricor Therapeutics, Inc. (CAPR) • • business
Key Points:
- The FDA has requested the full clinical study report (CSR) of Capricor Therapeutics' Phase 3 HOPE-3 trial as part of its Biologics License Application (BLA) review for Deramiocel, a cell therapy for Duchenne muscular dystrophy (DMD), without requiring new clinical studies or patient data.
- Capricor plans to submit the requested HOPE-3 CSR and supporting data to the FDA by February 2026, aiming to address the Complete Response Letter (CRL) and support continued BLA review with a new Prescription Drug User Fee Act (PDUFA) target date.
- Deramiocel, an allogeneic cardiosphere-derived cell therapy, has shown statistically significant
