Robbins LLP is Investigating Allegations that Capricor Therapeutics Misled Investors About the Path to FDA Approval for Deramiocel

Robbins LLP informs investors that a securities class action has been filed on behalf of all persons and entities that purchased or otherwise acquired Capricor Therapeutics, Inc. (NASDAQ: CAPR) securities between December 17, 2025 and July 26, 2026 (the "Class Period").

The lawsuit alleges that Capricor Therapeutics misled investors regarding the path to FDA approval for its lead product candidate Deramiocel, a cell therapy to address cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy.

Investors who suffered losses during the Class Period may have legal rights and should contact Robbins LLP for information about seeking appointment as lead plaintiff.

Why Was Capricor Therapeutics Sued?

Capricor is a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, including Duchenne muscular dystrophy (“DMD”). The Company’s lead product candidate is Deramiocel, an investigational cell therapy intended to address cardiac and skeletal muscle complications associated with DMD.

According to the complaint, Capricor submitted a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for Deramiocel in late 2024. In July 2025, the FDA issued a Complete Response Letter stating that the BLA did not meet the statutory requirement for substantial evidence of effectiveness and requesting additional clinical data.

The complaint alleges that, during the Class Period, Capricor made positive statements regarding the clinical results for Deramiocel and the prospects for FDA approval while failing to disclose material information concerning changes to the pre-specified statistical analysis plan (“SAP”) used to analyze clinical data from the Phase 3 HOPE-3 trial.

Specifically, the complaint alleges that defendants failed to disclose:

 (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.

Why did CAPR's Stock Drop 64%?

According to the complaint, following the FDA disclosures on July 27, 2026, Capricor’s stock price fell $12.70 per share, or approximately 64%, to close at $7.00 per share.

On July 29, 2026, the FDA advisory committee met to discuss the Deramiocel BLA. According to the complaint, the following day Medscape reported that the advisory committee relied on SAP version 1.1 as the “prespecified plan” and, in a non-binding 9-3 vote, concluded that the available evidence did not support the efficacy of Deramiocel for treating DMD-associated cardiomyopathy.

The complaint alleges that, following this news, Capricor’s stock price fell another $2.38 per share, or approximately 36%, to close at $4.19 per share on July 30, 2026, again on unusually heavy trading volume.

Who May Be Eligible?

If you purchased or otherwise acquired Capricor securities between December 17, 2025 and July 26, 2026, and suffered a loss, you may be eligible to participate in the proposed class action.

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