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Capricor Therapeutics, Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. September 15, 2025 Deadline to file Lead Plaintiff Motion
Capricor TherapeuticsCapricor Therapeutics(US:CAPR) GlobeNewswire News Roomยท2025-08-18 21:57

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the safety and efficacy data of its drug, deramiocel, during the Class Period from October 9, 2024, to July 10, 2025 [1][4]. Group 1: Company Overview - Capricor is a clinical-stage biotechnology company focused on developing cell- and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other diseases [3]. Group 2: Allegations and Stock Performance - The lawsuit claims that Capricor made false or misleading statements about the four-year safety and efficacy data from its Phase 2 HOPE-2 trial, leading to a false impression of potential approval for DMD cardiomyopathy [4]. - On May 5, 2025, Capricor announced a mid-cycle review with the FDA, reporting no significant deficiencies, but the stock fell over 29% following this news [5]. - Following a report on June 20, 2025, regarding the cancellation of an FDA advisory committee meeting due to concerns over deramiocel's efficacy and safety, Capricor's stock dropped more than 30% [6]. - On July 11, 2025, Capricor received a Complete Response Letter from the FDA denying its Biologics License Application for deramiocel, resulting in a nearly 33% decline in stock price [7].