India, July 11 -- Capricor Therapeutics, Inc. (CAPR) Friday said that the U.S. Food and Drug Administration (FDA) has declined to approve its lead cell therapy candidate Deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Following the news, the company's shares were more than 55% down in pre-market.
The FDA has issued a Complete Response Letter (CRL) citing that the Biologics License Application (BLA) does not meet the required evidence of effectiveness and need additional clinical data.
Capricor plans to resubmit BLA to include data from the ongoing Phase 3 HOPE-3 study in the third quarter. Capricor stock had closed at $11.40, down 0.18% on Thursday. It has traded in the range of $3.52 - $2...