Capricor Therapeutics Faces Class Action Lawsuit Over Clinical Data

The lawsuit alleges that Capricor executives misled shareholders concerning the regulatory pathway and clinical trial data for Deramiocel, a treatment for Duchenne muscular dystrophy. Specifically, the complaint asserts the company altered its statistical analysis plan without obtaining the required approval from the U.S. Food and Drug Administration before resubmitting its Biologics License Application.

Optimism surrounding the drug peaked on December 3, 2025, when Capricor touted positive results from the HOPE-3 study. Shares jumped 370% in response, prompting the company to launch a public offering of 6 million shares at $25 apiece. This narrative collapsed on July 27, 2026, following the release of an FDA briefing document. Regulators stated the HOPE-3 study failed to meet its primary and secondary efficacy endpoints and highlighted that the company had modified its analysis methods without authorization. The revelation triggered a 64% drop in the company's stock price, closing at $7 that day.

Reed Kathrein, the Hagens Berman partner leading the investigation, stated the firm is focused on uncovering the extent to which management characterized trial endpoints and undisclosed modifications. Affected investors have until September 28, 2026, to petition the court for lead plaintiff status. While this role allows for a more active part in the litigation, it is not a requirement for participating in any potential financial recovery.