Deadline Soon: Capricor Therapeutics, Inc. (CAPR) Shareholders Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz About Securities Fraud Lawsuit

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz reminds investors of the upcoming September 28, 2026 deadline to participate as a lead plaintiff in the securities fraud class action lawsuit filed on behalf of investors who acquired Capricor Therapeutics, Inc. ("Capricor" or the Company") (NASDAQ: CAPR) securities between December 17, 2025 and July 26, 2026, inclusive (the “Class Period”).

IF YOU ARE AN INVESTOR WHO LOST MONEY ON CAPRICOR THERAPEUTICS, INC. (CAPR), CLICK HERE TO PARTICIPATE IN THE SECURITIES FRAUD LAWSUIT.

What Happened?

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 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.

What Is The Lawsuit About?

The complaint filed in this class action alleges that between December 17, 2025 and July 26, 2026, 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.

If you purchased or otherwise acquired Capricor Therapeutics, Inc. securities between December 17, 2025 and July 26, 2026, the deadline to seek appointment as the lead plaintiff in the securities fraud class action is September 28, 2026.

Contact Us To Participate or Learn More:

If you wish to learn more about this class action, or if you have any questions concerning this announcement or your rights or interests with respect to the pending class action lawsuit, please contact us:

Frank R. Cruz
The Law Offices of Frank R. Cruz,
2121 Avenue of the Stars, Suite 800,
Century City, California 90067
Email us at: [e-mail]
Call us at: 310-914-5007
Visit our website at www.frankcruzlaw.com
Follow us for updates on Twitter: twitter.com/FRC_LAW

If you inquire by email, please include your mailing address, telephone number, and number of shares purchased.

To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.