Securities Fraud Investigation Into Capricor Therapeutics, Inc. (CAPR) Announced Following Critical FDA Review Ahead of Advisory Committee Meeting – Shareholders Who Lost Money Urged To Contact The Law Offices of Frank R. Cruz

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) on behalf of investors concerning the Company’s possible violations of federal securities laws.

IF YOU ARE AN INVESTOR WHO LOST MONEY ON CAPRICOR THERAPEUTICS, INC. (CAPR), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING A CLAIM TO RECOVER YOUR LOSS.

What Is The Investigation About?

On July 27, 2026, the US Food and Drug Administration released briefing documents ahead of its advisory committee meeting with Capricor regarding the Company's cell therapy for a heart condition related to Duchenne muscular dystrophy.

Among other things, the briefing documents take issue with the manner in which Capricor measured results after the therapy's late-stage trial ended, stating 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." The briefing documents conclude that, among other things, "the benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness."

Cantor Fitzgerald analyst Kristen Kluska published an investor note on the issue, 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, shares of Capricor stock declined as much as $12.29, or 62.39%, during intraday trading on July 27, 2026.

Contact Us To Participate or Learn More:

If you purchased Capricor securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us:

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

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

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