The lawsuit alleges that Capricor Therapeutics issued materially misleading statements regarding its cell therapy candidate, Deramiocel. Specifically, the complaint claims the company altered its statistical analysis plan for clinical data without prior FDA agreement before resubmitting its Biologics License Application. This oversight allegedly created significant regulatory risks for the treatment of Duchenne muscular dystrophy, which were not disclosed to shareholders.

Investors seeking to participate in the litigation are not required to pay out-of-pocket fees, as the firm operates on a contingency arrangement. While no class has been certified yet, those interested in serving as a lead plaintiff must file their motion with the court by the September deadline. Alternatively, investors may choose to retain their own counsel or remain absent class members, as the ability to share in any potential recovery does not require taking on a leadership role in the lawsuit.