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As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (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.
On July 27, 2026, before the market opened, the FDA released briefing documents ahead of its AdCom meeting for the BLA, stating that the "benefit-risk assessment for deramiocel appears unfavorable in the absence of evidence of effectiveness." On this news, Capricor's stock fell $12.70, or 64%, to close at $7.00 per share on July 27, 2026, on unusually heavy trading volume.
On July 29, 2026, the AdCom met to discuss the Deramiocel BLA, and the panel, in a non-binding 9-3 vote, "concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy." On this news, Capricor's stock fell $2.38, or 36%, to close at $4.19 per share on July 30, 2026, on unusually heavy trading volume.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding Capricor's conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
To learn more about the Capricor class action, go to www.faruqilaw.com/CAPR or call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).
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Frequently Asked Questions (FAQ) for Investors Regarding the Capricor Securities Class Action Lawsuit:
What is the Capricor securities fraud lawsuit about?
The lawsuit alleges that Capricor Therapeutics, Inc. (NASDAQ: CAPR) and certain of its officers and directors made materially misleading statements and omissions regarding the regulatory prospects for Deramiocel, the Company's therapy for Duchenne muscular dystrophy. Specifically, the complaint alleges that the Company adopted changes to the pre-specified statistical analysis plan used to analyze Deramiocel's clinical data without first obtaining FDA agreement to those changes before resubmitting the Deramiocel Biologics License Application. As a result of these allegedly undisclosed circumstances, the lawsuit contends that there was a significant risk the FDA could conclude that the clinical results did not provide substantial evidence of Deramiocel's effectiveness, creating a substantial risk to the drug's regulatory approval. Investors allegedly suffered losses when, on July 27, 2026, the FDA released briefing documents stating that the benefit-risk assessment for Deramiocel appeared unfavorable in the absence of evidence of effectiveness, causing Capricor's stock to fall approximately 64%, and again on July 30, 2026, following the AdCom panel's non-binding 9-3 vote concluding that available evidence does not support Deramiocel's efficacy for DMD-associated cardiomyopathy, causing the stock to fall an additional approximately 36%.
Who may be eligible to participate in the lawsuit?
Investors who purchased or otherwise acquired Capricor Therapeutics, Inc. (NASDAQ: CAPR) securities on the NASDAQ exchange between December 17, 2025 and July 26, 2026, inclusive, may be eligible to participate in this class action lawsuit. The lawsuit is brought on behalf of all such investors as a class, and participation is not limited to those who seek appointment as lead plaintiff. Any investor who falls within the defined class period may potentially share in any recovery that may be obtained, subject to the outcome of the litigation. Eligible investors are encouraged to review their trading records to confirm whether their purchases fall within the Class Period.
What is a lead plaintiff, and how can I seek appointment?
A lead plaintiff is a court-appointed representative who acts on behalf of all class members in directing the litigation, including working with counsel to make key strategic decisions about the prosecution of the case. Any investor who purchased Capricor Therapeutics securities during the Class Period may move the court for appointment as lead plaintiff, but a motion seeking that appointment must be filed no later than September 28, 2026. Courts generally appoint as lead plaintiff the movant who allegedly suffered the largest financial loss and otherwise satisfies the requirements of the applicable securities laws. Importantly, investors do not need to seek or serve as lead plaintiff in order to participate in the class and potentially share in any recovery that may result from the litigation.
What should investors do if they purchased Capricor stock during the Class Period?
Investors who purchased Capricor Therapeutics, Inc. (NASDAQ: CAPR) securities between December 17, 2025 and July 26, 2026 are encouraged to promptly review their brokerage and trading records to determine whether their purchases fall within the Class Period. Investors should also consider preserving all relevant documentation, including trade confirmations, account statements, and any communications relating to their investment in Capricor Therapeutics, as such records may be relevant to establishing losses or participation in the litigation. Affected investors may wish to consult with Faruqi & Faruqi, LLP or other qualified securities counsel to better understand their legal rights and options before the September 28, 2026 lead plaintiff deadline. Consulting with counsel before that deadline does not obligate an investor to serve as lead plaintiff, and class members who do not seek appointment as lead plaintiff may still potentially share in any recovery obtained on behalf of the class.
Why should investors contact Faruqi & Faruqi, LLP?
Faruqi & Faruqi, LLP has represented investors in securities litigation for decades and has recovered hundreds of millions of dollars for shareholders. Investors who purchased Capricor securities during the Class Period may contact the firm to discuss their legal rights, potential claims, and the lead plaintiff process at no cost or obligation.
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SOURCE Faruqi & Faruqi, LLP
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