regulatory
confidence high
sentiment negative
materiality 0.90
Capricor receives FDA Complete Response Letter for Deramiocel BLA; plans Q3 2025 resubmission with HOPE-3 data
CAPRICOR THERAPEUTICS, INC.
- FDA issued CRL stating BLA lacks substantial evidence of effectiveness; additional clinical data needed.
- Capricor plans to resubmit BLA in Q3 2025 with data from ongoing Phase 3 HOPE-3 trial (104 patients, topline Q3 2025).
- FDA confirmed review clock restarts upon resubmission; Type A meeting offered to discuss path forward.
- CRL referenced outstanding CMC items, but Capricor believes most were addressed; not reviewed due to CRL timing.
- Prior to CRL, BLA had Priority Review, successful pre-licensure inspection, and mid-cycle review completion.