NEW YORK, Aug. 27, 2026 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
The class action concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
You have until September 28, 2026, to ask the Court to appoint you as Lead Plaintiff for the class if you purchased or otherwise acquired Capricor securities during the Class Period. A copy of the Complaint can be obtained at www.pomerantzlaw.com.
[Click here for information about joining the class action]
In late 2024, Capricor submitted its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration for Deramiocel as a cell therapy for the treatment of Duchenne muscular dystrophy. In July 2025, the FDA issued a Complete Response Letter because it could not approve the BLA in its current form. According to the Company, the CRL cited “that the BLA does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.” By March 2026, Capricor claimed it had addressed the issues identified in the CRL.
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 BLA. According to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan (“SAP”) and that the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.” Critically, the final SAP was created one day before the data was unblinded. 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’s stock price fell $12.70 per share, or 64%, to close at $7.00 per share on July 27, 2026.
Then, on July 29, 2026, the AdCom met to discuss the Deramiocel BLA. The next day, Medscape reported that the panel relied on SAP version 1.1 as the “prespecified plan” and, in a non-binding 9-3 vote, the panel “concluded that the available evidence does not support the efficacy of deramiocel for treating DMDassociated cardiomyopathy.”
On this news, Capricor’s stock price fell $2.38 per share, or 36%, to close at $4.19 per shar eon July 30, 2026.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
View original content to download multimedia:https://www.prnewswire.com/news-releases/investor-alert-pomerantz-law-firm-reminds-investors-with-losses-on-their-investment-in-capricor-therapeutics-inc-of-class-action-lawsuit-and-upcoming-deadlines–capr-302862301.html
SOURCE Pomerantz LLP
