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 Glancy Prongay Wolke & Rotter LLP

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay Wolke & Rotter LLP, a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) investors concerning the Company’s possible violations of the federal securities laws.

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

What Happened?

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 wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us.

Charles Linehan, Esq.
Glancy Prongay Wolke & Rotter LLP
1925 Century Park East, Suite 2100
Los Angeles California 90067
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Whistleblower Notice

Persons with non-public information regarding Capricor should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email [e-mail].

About Glancy Prongay Wolke & Rotter LLP

GPWR is a premier law firm with decades of experience representing investors and consumers in securities litigation and other complex class action litigation. Recognizing the firm’s recent successes, GPWR was named one of Law360’s Securities Groups of the Year and ranked second-highest in total investor recoveries by Institutional Shareholder Services Securities Class Action Services in 2025. GPWR’s lawyers have handled cases covering a wide spectrum of corporate misconduct and relating to nearly all industries and sectors. GPWR’s past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron’s, Investor’s Business Daily, Forbes, and Money. Prior results do not guarantee a similar outcome.

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