Monday, 28 September 2026 09:59 PM
Class Action
NEW YORK CITY, NY / ACCESS Newswire / September 28, 2026 / Pomerantz LLP announces that a class action lawsuit has been filed against Capricor Therapeutics, Inc. ("Capricor " or the "Company") (NASDAQ:CAPR) and certain officers. The class action, filed in the United States District Court for the Southern District of California, is on behalf of persons and entities that purchased or otherwise acquired Capricor securities between December 3, 2025 and July 26, 2026, inclusive (the "Class Period"). Plaintiff pursues claims against the Defendants under the Securities Exchange Act of 1934.
If you are an investor who purchased or otherwise acquired Capricor securities during the Class Period, you have until September 28, 2026, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at [email protected] 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.
[Click here for information about joining the class action]
Capricor is a biotechnology company focused on the development of cell and exosome-based therapeutics for the treatment of Duchenne muscular dystrophy, a rare genetic disorder characterized by progressive muscle degeneration and premature death. Its lead product candidate is Deramiocel, a cell therapy to address cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy.
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."
The same day, at 11:00 a.m. ET, the Company provided "an update" ahead of the AdCom meeting, stating that "Capricor has engaged fully and transparently with the FDA throughout the review process" and that "[i]t is critical to understand that the post-hoc analyses in the FDA's briefing materials rely on SAP version 1.1, an unsigned incomplete internal draft which became obsolete with the addition of cohort B and did not include content specifically requested by the FDA."
The same day, Cantor Fitzgerald published an investor note, stating the FDA's "briefing documents paint an ugly picture" and "raise several concerns and make allegations about the integrity of data collecting."
On this news, Capricor's stock fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026, on unusually heavy trading volume.
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 DMD-associated cardiomyopathy."
On this news, Capricor's stock fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026, on unusually heavy trading volume.
The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company's business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the Company adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel; (2) that the FDA had not agreed to those changes before the Company resubmitted the Deramiocel BLA; (3) that, as a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel; (4) that, as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy; and (5) that, as a result of the foregoing, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
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 billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
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SOURCE: Pomerantz LLP