The complaint alleges that Capricor and its executives issued misleading statements regarding the clinical trial data for Deramiocel, a candidate for Duchenne muscular dystrophy. Following positive topline results announced in December 2025, the company secured capital through a public offering of 6 million shares priced at $25. However, a July 2026 FDA briefing document contradicted the company’s earlier characterizations of the HOPE-3 study, stating the trial failed to meet its primary and secondary endpoints.
Capricor Faces Class Action Lawsuit Following Deramiocel Trial Disclosures
A securities fraud class action has been filed against Capricor Therapeutics, Inc. after the FDA revealed that the company altered clinical trial statistical plans without regulatory consent. The lawsuit centers on a period of intense volatility that saw the firm’s share price surge by 370% before collapsing by 64%.
Regulators identified that Capricor had modified its pre-specified statistical analysis plan—including endpoint definitions and analytical methods—without FDA agreement. This disclosure triggered a sharp market correction on July 27, 2026, dropping the stock price to $7. Hagens Berman, the firm representing affected shareholders, is investigating whether management intentionally obscured these modifications to inflate the company's valuation. Investors who purchased Capricor securities between December 17, 2025, and July 26, 2026, have until September 28, 2026, to file for lead plaintiff status in the ongoing litigation.
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