The FDA issued a complete response letter to Capricor Therapeutics’ BLA for deramiocel in DMD cardiomyopathy, citing lack of evidence and unresolved CMC issues. Shares of CAPR dropped 33% in response. DMD is a genetic disorder with a median mortality age of 30. The FDA found the application did not meet statutory requirements for effectiveness evidence and noted CMC issues. Capricor plans to discuss with the FDA to clarify issues. An approval could have made deramiocel the first DMD cardiomyopathy therapy. Capricor’s stock has fallen 44.7% year to date. The company holds a Zacks Rank #3. Other biotech stocks to consider are Arvinas, Alkermes, and BioXcel Therapeutics, with Zacks Rank #1. ARVN, ALKS, and BTAI have shown improvements in earnings estimates over the past 60 days, with varying stock performances year to date.

Read more at Zacks Investment Research: FDA Rejects CAPR’s Cell Therapy BLA for Genetic Disorder, Stock Tanks – July 14, 2025