Investors File Securities Fraud Class Action Against Capricor Therapeutics

The litigation centers on claims that Capricor Therapeutics failed to disclose significant alterations to its pre-specified statistical analysis plan for Deramiocel clinical data. According to the complaint, the company resubmitted its Biologics License Application to the FDA without securing prior approval for these analytical changes. This omission allegedly created a substantial risk that the agency would find the clinical results insufficient to prove the therapy’s effectiveness for treating Duchenne muscular dystrophy.

Rosen Law Firm, which initiated the action, contends these undisclosed risks rendered the company’s public statements regarding its business and operational prospects materially misleading. Investors seeking to participate in the potential recovery or act as a representative party must reach out to the firm’s counsel before the late September deadline. No class has been certified yet, meaning investors may choose their own representation or remain absent members until a formal certification occurs.