Capricor's Lead Duchenne Therapy Hits FDA Regulatory Roadblock
1. CAPR received a Complete Response Letter from the FDA for Deramiocel. 2. FDA requires more clinical data to support the Biologics License Application. 3. Capricor plans to submit Phase 3 data from the HOPE-3 trial in 2025. 4. CAPR stock is down 37.4%, trading at $7.14 during premarket. 5. CEO expresses surprise at FDA's decision despite prior guidance followed.