SAN DIEGO, Aug. 24, 2026 /PRNewswire/ — 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 before the September 28, 2026 deadline.
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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 that:
(1) the Company adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel;
(2) the FDA did not agree to those changes before the Company resubmitted the Deramiocel BLA;
(3) there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel;
(4) as a result, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy; and
(5) therefore, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
What Problems Did the FDA Disclosures Reveal?
On July 27, 2026, the FDA released briefing documents ahead of its advisory committee meeting concerning Deramiocel. According to the briefing documents, Capricor made changes to the pre-specified statistical analysis plan (“SAP”) and the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”
The complaint further alleges that the FDA identified changes to endpoint definitions, analytical methods, and data-imputation strategies and stated that the final SAP was not submitted to the FDA for review before the BLA submission.
The FDA allegedly disagreed with certain changes to the SAP and considered analyses based on post-study versions of the SAP to be “post-hoc and exploratory.” The FDA briefing documents allegedly stated that the benefit-risk assessment for Deramiocel appeared unfavorable in the absence of evidence of effectiveness.
Capricor responded that it had engaged fully and transparently with the FDA and disputed the characterization of the SAP materials in the FDA briefing documents.
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.
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.
If you suffered a significant loss in Capricor securities, contact Robbins LLP to learn more about your rights and potential recovery.
What Is a Lead Plaintiff?
The lead plaintiff is the investor appointed by the court to represent the interests of the proposed class throughout the litigation. Investors do not have to serve as lead plaintiff to potentially share in any recovery if the lawsuit is successful.
Shareholders who wish to seek appointment as lead plaintiff must do so prior to September 28, 2026.
Does it Cost Anything to Participate?
No. Robbins LLP represents investors on a contingency fee basis. Investors never pay attorneys’ fees or litigation expenses. If there is a recovery, defendants pay fees and expenses.
Contact Robbins LLP
Investors seeking additional information about the Capricor Therapeutics, Inc. securities class action may submit an inquiry through Robbins LLP’s website, email attorney Aaron Dumas, Jr., or give us a call at (800) 350-6003.
About Robbins LLP
A recognized leader in shareholder rights litigation, Robbins LLP has helped restore more than $1 billion in value to shareholders and secured some of the largest recoveries in shareholder derivative litigation history.
“Behind everything we do is the belief that companies should be governed responsibly, fiduciaries should be held accountable, and shareholders deserve transparency and fairness,” said Brian J. Robbins, Founding Partner of Robbins LLP.
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SOURCE Robbins LLP
