Capricor Therapeutics (CAPR) provides regulatory update on deramiocel BLA following FDA review of hope-3 topline data
Importance
Level 1
- FDA requests hope-3 clinical study report for BLA review.
- Co. expects to submit BLA updates in February 2026.
- Expects to submit updates to BLA in February 2026 to support continued FDA review.
- FDA requests full hope-3 report to address CRL.
#FDA#EU SESSION#US SESSION#GLOBAL NEWS