The complaint alleges that Capricor manipulated the statistical analysis plan for its clinical trial data without first securing approval from the U.S. Food and Drug Administration. According to the court filing, the company proceeded to resubmit its Biologics License Application despite lacking this critical regulatory consensus. These actions form the basis of the claim that the firm provided materially false information to the market throughout the specified period.

The DJS Law Group, led by David J. Schwartz, is spearheading the effort to appoint lead plaintiffs for the case. Shareholders seeking to participate in the recovery process must act before the September 28, 2026, deadline. Legal representatives emphasize that those who suffered financial losses do not need to serve as lead plaintiffs to remain eligible for potential compensation.