
Core Viewpoint - Capricor Therapeutics, Inc. is facing a federal securities class action due to allegations of misleading statements regarding its lead drug candidate, deramiocel, and its failure to disclose material adverse facts related to its clinical trial data [3][4]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against Capricor and has set a deadline of September 15, 2025, for investors to seek the role of lead plaintiff in the class action [1][3]. - The complaint alleges that Capricor and its executives violated federal securities laws by making false statements about the drug deramiocel and its FDA approval process [3]. Group 2: Drug Development and Regulatory Issues - Capricor's lead drug candidate, deramiocel, is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [3]. - On July 11, 2025, Capricor received a Complete Response Letter (CRL) from the FDA, denying the Biologics License Application (BLA) due to insufficient evidence of effectiveness and the need for additional clinical data [4]. Group 3: Stock 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, indicating a significant market reaction to the news [5].