
Core Viewpoint - A class action has been filed against Capricor Therapeutics, Inc. for allegedly misleading investors regarding the viability of its lead product candidate, deramiocel, for treating Duchenne muscular dystrophy (DMD) [1][2]. Group 1: Company Overview - Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics for DMD and other diseases with unmet medical needs in the U.S. [1] - The company's lead product candidate is deramiocel, which consists of allogeneic cardiosphere-derived cells [1]. Group 2: Allegations and Legal Action - Robbins LLP is investigating allegations that Capricor misled investors about deramiocel's potential for first approval for DMD cardiomyopathy while concealing adverse facts regarding its safety and efficacy data from the Phase 2 HOPE-2 trial [2]. - The complaint states that the misleading information led to shareholders purchasing Capricor's securities at artificially inflated prices [2]. Group 3: Stock Price Impact - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying its Biologics License Application due to insufficient evidence of effectiveness and the need for additional clinical data [3]. - Following the announcement, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025 [3].