The complaint filed against the company alleges a pattern of deceptive practices occurring between December 17, 2025, and July 26, 2026. Plaintiffs claim that Capricor Therapeutics failed to disclose critical modifications to the statistical analysis plan used to evaluate clinical trial data for Deramiocel. Specifically, the suit asserts that the firm proceeded with these changes without prior FDA agreement, creating a concealed risk that the agency would find the clinical results insufficient for approval.

According to the legal filing, these omissions rendered the company's public statements regarding its business operations and development prospects materially misleading. By withholding the scope of the disagreement with federal regulators, the company allegedly obscured the substantial risks threatening the commercial viability of its lead therapeutic candidate. The Law Offices of Howard G. Smith, which is representing the class, has invited affected investors to discuss their legal standing and potential participation in the ongoing litigation via their Bensalem office.