CLASS ACTION NOTICE: Berger Montague Advises Capricor Therapeutics, Inc. (NASDAQ: CAPR) Investors to Inquire About a Securities Fraud Class Action

National plaintiffs' law firm Berger Montague PC announces a class action lawsuit against Capricor Therapeutics, Inc. (NASDAQ: CAPR ) ("Capricor" or the "Company") on behalf of investors who purchased or acquired Capricor securities during the period from December 17, 2025 through July 26, 2026 (the "Class Period").

Investors who purchased or acquired Capricor securities during the Class Period may, no later than September 28, 2026 , seek to be appointed as a lead plaintiff representative of the class. To learn your rights, CLICK HERE.

Headquartered in San Diego, Capricor is a clinical stage biotechnology company whose lead product candidate is Deramiocel, a cell therapy intended to treat patients suffering from Duchenne's muscular dystrophy.

As the lawsuit alleges , on July 27, 2026, before the market opened, the U.S. Food and Drug Administration ("FDA") released briefing documents ahead of its July 29 advisory committee ("AdCom") meeting for the biologics license application ("BLA") for Deramiocel. According to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan ("SAP"), and the final version "was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon."

The FDA disagreed with the changes made to the SAP, stating that the "FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy." As a result, the FDA stated that it "considers [Capricor's] analyses based on the post-study SAP versions to be post-hoc and exploratory." According to the briefing documents, " the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness."

On this news, Capricor shares fell $12.70 per share, or 64% , to close at $7.00 per share on July 27, 2026.

If you are a CAPRICOR investor and would like to learn more about this action, CLICK HERE or please contact Berger Montague: Andrew Abramowitz at [email protected] or (215) 875-3015, or Caitlin Adorni at [email protected] or (267) 764-4865.