Pomerantz says class action filed against Capricor over Deramiocel FDA disclosures

By Atlas Watchline Staff · Legal · September 3, 2026

Pomerantz LLP says investors who bought Capricor securities during the class period have until Sept. 28, 2026, to seek lead-plaintiff status in a class action tied to Deramiocel and FDA review disclosures.

Pomerantz LLP said on Sept. 3, 2026, that a class action lawsuit has been filed against Capricor Therapeutics Inc. The firm said the case concerns whether the company and certain officers and directors engaged in securities fraud or other unlawful business practices.

The alert is aimed at investors who purchased or otherwise acquired Capricor securities during the class period. It says they have until Sept. 28, 2026, to ask the court to appoint them as lead plaintiff.

The dispute centers on Capricor’s Deramiocel program, a cell therapy for Duchenne muscular dystrophy, and the company’s disclosures about the U.S. Food and Drug Administration review of its biologics license application. According to the alert, Capricor submitted the BLA in late 2024. The FDA issued a complete response letter in July 2025, and the company said the agency cited a lack of substantial evidence of effectiveness and a need for additional clinical data.

Pomerantz said Capricor later claimed, by March 2026, that it had addressed the issues raised in the CRL. The alert points to FDA briefing documents released before a July 29, 2026, advisory committee meeting. Those documents, as described in the alert, said changes to the pre-specified statistical analysis plan were not submitted for review before the BLA was filed and were not discussed or agreed upon. The FDA also said the final analysis plan was created one day before the data were unblinded.

According to the alert, the FDA further said converting raw change to percent change and back was not scientifically justified, and that analyses based on post-study versions of the statistical plan were post hoc and exploratory. The briefing documents said the benefit-risk assessment for deramiocel appeared unfavorable without evidence of effectiveness.

The alert links those developments to a sharp move in Capricor’s shares. It says the stock fell $12.70, or 64%, to $7.00 on July 27, 2026, after the briefing documents were released. It also says Medscape reported a 9-3 non-binding vote after the advisory committee met on July 29, 2026, with panelists concluding the evidence did not support deramiocel’s efficacy for treating Duchenne muscular dystrophy-associated cardiomyopathy. The alert says the stock then fell $2.38, or 36%, to $4.19 on July 30, 2026.

Pomerantz’s notice includes contact information for Danielle Peyton and says investors who inquire by email should include their mailing address, telephone number and number of shares purchased. The alert also contains standard attorney-advertising language.

Sources

• PR Newswire / Pomerantz LLP investor alert

Editorial note: This article was prepared with AI assistance and includes source attribution for reader review.

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