The legal complaint, filed on behalf of shareholders who purchased stock between December 17, 2025, and July 26, 2026, alleges that Capricor misled the market regarding the integrity of its clinical trial data. According to the filing, the company’s final study protocol deviated from its statistical analysis plan, with key changes implemented just one day before data unblinding. Plaintiffs contend these modifications were neither submitted to nor approved by the FDA before the company’s BLA resubmission.
Regulatory scrutiny intensified after the FDA characterized the company's final analyses as post-hoc and exploratory, noting that specific statistical adjustments lacked scientific justification. Furthermore, high rates of hypersensitivity reactions among participants potentially compromised the trial's double-blind nature. Following the release of FDA briefing documents and a subsequent 9-3 advisory committee vote against the drug's efficacy, Capricor shares plummeted from $19.70 to $4.19. Investors seeking to serve as lead plaintiff must file motions with the court by September 28, 2026.
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