Schall, Brown & Schwartz LLP, a firm specializing in shareholder rights, filed the complaint alleging that Capricor violated the Securities Exchange Act of 1934. The lawsuit centers on the company’s decision to alter its statistical analysis plan for Deramiocel clinical trials without securing prior FDA consent. According to the filing, this unauthorized shift occurred before the resubmission of the company’s Biologics License Application.

The complaint contends that these actions obscured significant risks regarding the drug’s potential for regulatory approval. By failing to disclose that the FDA had not agreed to the revised methodology, the company allegedly misled the market about the strength of evidence supporting Deramiocel’s effectiveness. Investors seeking to participate in the potential recovery or to serve as lead plaintiff must contact the firm by late September. Participation does not require formal appointment as lead plaintiff, and the class remains uncertified at this stage.