Capricor faces fraud suit after 64% stock collapse over FDA data

Capricor Therapeutics faces a securities fraud class action after its shares plunged 64 percent when FDA documents revealed undisclosed changes to its Deramiocel trial analysis.

"We're focused on investors' losses and uncovering the full scope of how management characterized these trial endpoints and undisclosed modification," Reed Kathrein, the Hagens Berman partner leading the firm's investigation, said.

The suit, filed in the U.S. District Court for the Southern District of California, covers investors who bought Capricor securities between December 17, 2025 and July 26, 2026. It alleges the company adopted changes to the pre-specified statistical analysis plan for Deramiocel, a cell therapy for Duchenne muscular dystrophy, without FDA agreement before resubmitting its Biologics License Application. The FDA issued a Complete Response Letter in July 2025 saying the application lacked substantial evidence of effectiveness.

On July 27, 2026, FDA briefing documents ahead of an advisory committee meeting raised concerns about the post-hoc changes, sending the stock down $12.70, or 64.5 percent, to $7.00. Two days later the panel voted 9-3 against the drug's efficacy, and shares fell another 36 percent to $4.19. Investors have until September 28, 2026 to seek lead plaintiff status.

The stock had surged 370 percent on December 3, 2025 after Capricor announced positive topline results from its Phase 3 HOPE-3 study, closing up $23.60. The next day the company launched a public offering of about 6 million shares at $25 each. Multiple firms, including Bleichmar Fonti & Auld, Glancy Prongay Wolke & Rotter, and Bronstein Gewirtz & Grossman, are soliciting affected investors.

Capricor reported a second-quarter net loss of $40.7 million with $237.9 million in cash and marketable securities. Management skipped the analyst question-and-answer session on the earnings call, citing ongoing discussions with the FDA.

The decline puts the stock near its lowest levels since the HOPE-3 data release, testing investor confidence in the regulatory path. The FDA's final decision on Deramiocel, expected after the advisory committee's negative vote, will determine whether the company can salvage its lead program.

This article is for informational purposes only and does not constitute investment advice.