Investors Sue Capricor Therapeutics Over Drug Approval Process

Pomerantz LLP has initiated a class action lawsuit against Capricor Therapeutics, Inc. (NASDAQ: CAPR), representing investors who have incurred losses on their investments. The lawsuit alleges that Capricor and certain of its officers and directors engaged in securities fraud or other unlawful business practices.

Investors who purchased Capricor securities during the specified class period have until September 28, 2026, to petition the court to be appointed as Lead Plaintiff. The core of the legal action revolves around Capricor's attempts to gain U.S. Food and Drug Administration (FDA) approval for its cell therapy, Deramiocel, intended for treating Duchenne muscular dystrophy.

Capricor submitted its Biologics License Application (BLA) for Deramiocel in late 2024. The FDA issued a Complete Response Letter in July 2025, indicating the BLA could not be approved in its current form due to insufficient evidence and a need for additional clinical data. Capricor stated in March 2026 that it had addressed the FDA's concerns.

However, in July 2026, FDA briefing documents released ahead of an advisory committee meeting revealed that Capricor had altered its statistical analysis plan (SAP) after the BLA submission. The FDA contended these changes were not scientifically justified and were considered "post-hoc," thereby undermining the drug's effectiveness claims. Subsequently, on July 29, 2026, an FDA advisory committee voted 9-3 against recommending approval for Deramiocel, citing insufficient evidence of efficacy.

In response to these developments, Capricor's stock price saw significant declines. It dropped 64% on July 27, 2026, following the release of the FDA's briefing documents, and fell another 36% on July 30, 2026, after the advisory committee's vote. Pomerantz LLP, a firm specializing in class action litigation, is urging affected investors to contact them for more information.