The lawsuit claims that Capricor Therapeutics failed to disclose critical modifications made to the pre-specified statistical analysis plan for Deramiocel. Specifically, the complaint alleges the company resubmitted its Biologics License Application to the FDA without obtaining prior agreement on these analytical changes. This failure allegedly created a significant risk that the regulatory body would deem the clinical results insufficient to prove the therapy’s effectiveness.

According to the legal filing, these omissions rendered the company's public statements regarding its business operations and regulatory prospects materially misleading. Investors who suffered losses following the disclosure of these details are encouraged to contact the Rosen Law Firm. Prospective lead plaintiffs must file their motions with the court by September 28, 2026. While the lawsuit is active, no class has been certified, meaning investors may choose their own counsel or remain absent class members without forfeiting their ability to participate in potential future recoveries.