
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 safety and efficacy data from its 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].