Kehoe Law Firm, P.C. is investigating potential securities claims on behalf of investors of Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR).
FDA Concerns About the Effectiveness Data for Capricor’s Cell Therapy for Heart Condition Related to Duchenne Muscular Dystrophy
On July 27, 2026, the U.S. Food and Drug Administration (“FDA”) released briefing materials concerning Capricor’s application for FDA approval of deramiocel, an investigational cell therapy for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy.
According to Reuters, “FDA staff reviewers raised concerns about the effectiveness data for Capricor Therapeutics’ cell therapy for a heart condition related to Duchenne muscular dystrophy . . ..” Reuters reported that “[t]he agency’s staff said Capricor changed how it measured the main results after the therapy’s late-stage trial ended, calculating arm-function performance as a percentage change instead of the original plan of analyzing scores in a 42-point test.”
On July 29, 2026, Stocktwits (via Yahoo Finance) reported that “[s]hares of Capricor . . . are on track for a record weekly selloff after an [FDA] advisory panel voted 9-3 against Deramiocel . . ..”
Stocktwits further reported that “[t]he FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee concluded on Wednesday that Capricor had not shown substantial evidence that Deramiocel effectively treats cardiomyopathy in DMD. Several panelists said the data was not convincing enough.”
On this news, shares of Capricor stock declined approximately 67%, closing at $6.57 per share on July 29, 2026. In premarket trading on July 30, 2026, Capricor shares fell an additional 50%, trading below $3.00 per share.
Capricor Securities Class Action Filed
On July 30, 2026, a class action alleging violations of federal securities laws was filed on behalf of Capricor investors who purchased or otherwise acquired Capricor securities between December 17, 2025 and July 26, 2026, both dates inclusive (the “Class Period”).
Details of the securities class action complaint can be accessed by clicking Capricor Therapeutics Class Action.
Capricor Shareholder Derivative Complaint Filed
On August 7, 2026, a verified shareholder derivative complaint was filed in federal court alleging that during the Relevant Period (December 17, 2025-July 26, 2026), the individual Capricor’s Defendants breached their fiduciary duties by personally making and/or causing the Company to make to the investing public a series of materially false and misleading statements regarding the Company’s business, operations, and prospects.
According to the complaint, the individual Defendants willfully or recklessly made and/or caused the Company to make false and misleading statements that failed to disclose, among other things, that:
(1) the pre-specified statistical analysis plan used for analysis of clinical data for Deramiocel was altered;
(2) the FDA did not agree to those alterations prior to the Company’s resubmission of the Deramiocel Biologics License Application, and as a result, there was a substantial risk of the FDA disapproving of the clinical results for lack of substantial evidence of effectiveness of Deramiocel; and, consequently,
3) the regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy was at substantial risk.
A copy of the shareholder derivative complaint can be viewed by clicking “Capricor Shareholder Derivative Complaint.”
Capricor Investors May Have Legal Claims
Capricor investors who acquired their securities during the Class Period are encouraged to complete Kehoe Law Firm’s Stockholder Information Request Form or contact Michael Yarnoff, Esq., (215) 792-6676, Ext. 804, [email protected], [email protected], to learn more about the investigation and receive a free, no-obligation evaluation of potential legal claims.
About Kehoe Law Firm, P.C.
Kehoe Law Firm, P.C. is a nationally recognized, plaintiff-side class action firm dedicated to protecting investors and consumers from fraud and misconduct. Our attorneys have served as Lead or Co-Lead Counsel in major securities cases, recovering over $10 billion for institutional and individual investors.
Our firm litigates securities fraud, fiduciary breaches, unfair mergers and acquisitions, and antitrust violations, while also representing whistleblowers and advocating for victims of data breaches, consumer fraud, vehicle and product defects, employment law violations, retirement plan mismanagement, and other corporate and business misconduct. With a results-driven approach, we pursue justice and substantial recoveries for those we represent.
Kehoe Law Firm’s class action legal services are provided on a contingency-fee basis, meaning clients are not responsible for any fees or litigation expenses.
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