Capricor Therapeutics Inc. is facing a class action securities lawsuit following allegations of securities fraud. The lawsuit, filed on behalf of investors who suffered financial losses, claims that between October 9, 2024, and July 10, 2025, the company and its executives disseminated false and misleading information regarding its lead cell therapy candidate drug, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy. The lawsuit contends that Capricor provided overwhelmingly positive statements about the potential to obtain a Biologics License Application from the FDA while concealing adverse facts about the drug's safety and efficacy from its Phase 2 HOPE-2 trial. The announcement of a Complete Response Letter from the FDA, which cited the need for additional clinical data, led to a significant drop in Capricor's stock price. Levi & Korsinsky, LLP, a law firm with a strong track record in securities litigation, is handling the case.