Capricor Therapeutics Faces Securities Fraud Lawsuit Over Deramiocel Data Allegations

SAN DIEGO, Sept. 10, 2026 /CourierPR/ -- Capricor Therapeutics, Inc., a biotechnology company developing cell and exosome-based therapies for Duchenne muscular dystrophy, faces a lawsuit filed by Robbins Geller Rudman & Dowd LLP on behalf of investors who purchased its securities between December 17, 2025, and July 26, 2026. The lawsuit alleges that Capricor and certain top executives violated the Securities Exchange Act of 1934 by making false and misleading statements, and failing to disclose that the company had made unauthorized changes to the statistical analysis plan used for its lead product candidate, Deramiocel.

According to the complaint, Capricor had submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) that included an altered pre-specified statistical analysis plan. The FDA had not been informed or agreed to these changes. As a result, the FDA's briefing documents, released before its July 29 advisory committee meeting, highlighted significant concerns about the clinical trial data for Deramiocel. The documents stated that the final version of the statistical analysis plan was created one day before the data was unblinded, and that the FDA did not consider the post-hoc analyses scientifically justified.

On July 27, Capricor issued a press release to inform investors about the FDA's briefing documents. The company stated that it had engaged fully and transparently with the FDA throughout the review process, and that the post-hoc analyses relied on an unsigned and incomplete internal draft. However, the complaint alleges that Capricor's actions were misleading, as the FDA had already raised concerns about the integrity of the data collection. This news caused the company's stock price to plummet by 64% that day.

The advisory committee met on July 29, and the FDA's briefing documents influenced their decision. The committee concluded that the available evidence did not support the efficacy of Deramiocel for treating Duchenne muscular dystrophy-associated cardiomyopathy, leading to a further 36% decline in Capricor's stock price.

Investors with substantial losses due to these alleged violations have until September 28, 2026, to seek appointment as lead plaintiff in the lawsuit. Robbins Geller Rudman & Dowd LLP is urging investors who purchased or acquired Capricor securities during the specified class period to contact the law firm to explore their options. The firm has a history of recovering significant sums for investors in securities fraud cases.