Capricor Therapeutics(US:CAPR) Prnewswireยท2025-08-08 13:55Core Viewpoint - The complaint alleges that Capricor and its executives violated federal securities laws by making false or misleading statements regarding the drug deramiocel, which is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2] Group 1: Company Conduct - Capricor allegedly provided investors with overly positive statements about its ability to obtain a Biologics License Application (BLA) from the FDA while concealing adverse facts related to the safety and efficacy data from its Phase 2 HOPE-2 trial [2] - On July 11, 2025, Capricor received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness and the need for additional clinical data [3] Group 2: Market Reaction - Following the announcement of the CRL, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, reflecting a significant decline in investor confidence [4]