Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the safety and efficacy 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 reported completion of a mid-cycle review with the FDA, which led to a stock drop of over 29% [5]. - Following a report on June 20, 2025, regarding skepticism from the FDA about deramiocel's efficacy and safety, Capricor's stock fell more than 30% [6]. - On July 11, 2025, Capricor announced it received a Complete Response Letter from the FDA denying its Biologics License Application for deramiocel, resulting in a nearly 33% drop in stock price [7].
Capricor Therapeutics, Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. September 15, 2025 Deadline to file Lead Plaintiff Motion.