Capricor Therapeutics Inc. is facing a class action securities lawsuit filed on behalf of investors who suffered financial losses due to alleged securities fraud. The lawsuit covers the period between October 9, 2024, and July 10, 2025, during which Capricor allegedly misled investors about the efficacy and safety of its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy. The company reportedly provided false and misleading statements concerning the drug's Phase 2 HOPE-2 trial data and its potential to secure a Biologics License Application from the FDA. Following the FDA's issuance of a Complete Response Letter denying the BLA, citing insufficient evidence of effectiveness and unresolved issues in the manufacturing section, Capricor's stock price sharply declined. The law firm Levi & Korsinsky, LLP, known for its expertise in securities litigation, is representing the affected shareholders in this legal action.