
Core Viewpoint - The complaint alleges that Capricor and its executives violated federal securities laws by making false or misleading statements regarding the effectiveness and safety data of their lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2] Group 1: Company Performance and Regulatory Issues - Capricor received a Complete Response Letter (CRL) from the FDA on July 11, 2025, denying the Biologics License Application (BLA) due to insufficient evidence of effectiveness and the need for additional clinical data [3] - The CRL also highlighted outstanding issues in the Chemistry, Manufacturing, and Controls section of the application [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, indicating a significant market reaction to the news [4]