Capricor Therapeutics, Inc. is facing a proposed securities class action alleging it misled investors about regulatory risks tied to Deramiocel, its cell therapy for Duchenne muscular dystrophy. The proposed class covers purchasers of Capricor securities between Dec. 17, 2025 and July 26, 2026, and investors seeking to serve as lead plaintiff must move the court by Sept. 28, 2026. The lawsuit alleges Capricor adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel, but that the FDA had not agreed to those changes before the company resubmitted its Biologics License Application. According to the complaint, that created a significant risk the FDA could determine the clinical results did not provide substantial evidence of effectiveness, putting regulatory approval for Deramiocel at risk and rendering the company's positive statements about its business, operations and prospects materially misleading. The case, announced by Rosen Law Firm, seeks compensation for investors who purchased during the class period. The firm said a class action has already been filed and noted that investors do not need to serve as lead plaintiff to share in any potential recovery.