
Core Viewpoint - A class action lawsuit has been filed against Capricor Therapeutics, Inc. for allegedly misleading investors about the viability of its lead product candidate, deramiocel, during the class period from October 9, 2024, to July 10, 2025 [1][2]. Company Overview - Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the U.S. [1]. Allegations - The lawsuit claims that Capricor misled investors regarding the effectiveness of deramiocel for treating cardiomyopathy associated with DMD, creating a false impression of its approval prospects while concealing adverse safety and efficacy data from its Phase 2 HOPE-2 trial [2]. - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, which denied its Biologics License Application, citing insufficient evidence of effectiveness and the need for additional clinical data [3]. Stock Impact - 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, reflecting a significant decline in investor confidence [3].