Pomerantz says Sept. 28 is lead-plaintiff deadline in Capricor class action

Pomerantz LLP said a securities class action has been filed against Capricor Therapeutics Inc. and that investors who bought or otherwise acquired the company’s securities during the class period have until Sept. 28, 2026, to ask the court to appoint them lead plaintiff.

The firm’s investor alert, published Aug. 27, says the case concerns whether Capricor and certain officers or directors engaged in securities fraud or other unlawful business practices tied to the company’s Deramiocel biologics license application and later FDA developments. Capricor trades on Nasdaq under the symbol CAPR.

The dispute centers on Capricor’s late-2024 application for Deramiocel, a cell therapy the company says is for Duchenne muscular dystrophy. According to the alert, the FDA issued a complete response letter in July 2025 saying the application could not be approved in its current form because it did not meet the statutory requirement for substantial evidence of effectiveness and needed more clinical data.

Pomerantz said FDA briefing documents released on July 27, 2026, before a July 29 advisory committee meeting, raised questions about the company’s analysis plan. The alert says the documents stated Capricor changed the pre-specified statistical analysis plan and that the final version was not submitted to FDA before the BLA was filed or agreed upon. The documents also said the conversion of raw change to percent change and back was not scientifically justified, and that analyses based on post-study versions of the plan were post-hoc and exploratory.

Those FDA materials also said the benefit-risk assessment for Deramiocel appeared unfavorable in the absence of evidence of effectiveness, according to the alert. Pomerantz said Capricor stock fell 64% to $7.00 on July 27 after the briefing documents were released.

The alert says the advisory committee met on July 29 to discuss the application. It adds that Medscape reported a 9-3 non-binding vote and said the panel concluded the available evidence does not support efficacy of Deramiocel for Duchenne muscular dystrophy-associated cardiomyopathy. Pomerantz said the stock then fell another 36% to $4.19 on July 30.

The lawsuit itself was not included in the research brief, and the alert does not resolve the underlying claims. Pomerantz’s notice instead directs affected investors to contact the firm if they want to be considered for lead-plaintiff status before the Sept. 28 deadline.

Sources

• PR Newswire / Pomerantz LLP investor alert

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