FDA Rejects CAPR's Cell Therapy BLA for Genetic Disorder, Stock Tanks

Key Takeaways CAPR's BLA for deramiocel in DMD cardiomyopathy received an FDA complete response letter. The FDA cited a lack of substantial evidence and unresolved CMC issues in the BLA. CAPR plans talks with the FDA to clarify issues and chart a regulatory path for deramiocel.Shares of Capricor Therapeutics (CAPR) tanked 33% on Friday after it announced that the FDA issued a complete response letter (“CRL”) to the biologics license application (“BLA”) seeking approval for cell therapy deramiocel, to trea ...