
Core Viewpoint - A class action lawsuit has been filed against Capricor Therapeutics, Inc. for allegedly providing misleading information regarding its lead drug candidate, deramiocel, leading to investor losses during the specified class period [1][3]. Group 1: Lawsuit Details - The lawsuit is on behalf of all individuals and entities who purchased Capricor securities between October 9, 2024, and July 10, 2025 [1]. - Investors have until September 15, 2025, to apply to the Court to be appointed as lead plaintiff in the lawsuit [1]. Group 2: Allegations Against Capricor - The complaint alleges that Capricor provided materially misleading information about deramiocel's potential to receive a Biologics License Application (BLA) approval from the FDA [3]. - It is claimed that while making positive statements, Capricor concealed adverse facts regarding the safety and efficacy data from its Phase 2 HOPE-2 trial [3]. Group 3: Impact of FDA Response - On July 11, 2025, Capricor announced it 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 [4]. - 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 [5].