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.
In section Releases
Capricor Therapeutics Investors Face Class Action Over Clinical Data
Investors who incurred significant losses in Capricor Therapeutics, Inc. have until September 28, 2026, to file as lead plaintiffs in a pending securities fraud class action. The lawsuit centers on allegations that the company misled shareholders regarding the regulatory approval process for its Duchenne muscular dystrophy treatment, Deramiocel.
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.
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