CAPR Updates FDA on Deramiocel BLA, Plans HOPE-3 CSR Filing in February

Key Takeaways CAPR said the FDA requested the full HOPE-3 clinical study report to advance its Deramiocel BLA review.CAPR plans to submit the HOPE-3 CSR in February 2026 to address issues cited in last year's CRL.CAPR noted the FDA did not request new trials or data, keeping Deramiocel on a defined regulatory path.Capricor Therapeutics (CAPR) recently provided a regulatory update on its Biologics License Application (BLA) for Deramiocel, following recent interactions with the FDA. After reviewing topline da ...

Capricor Therapeutics-CAPR Updates FDA on Deramiocel BLA, Plans HOPE-3 CSR Filing in February - Reportify