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Capricor Therapeutics, Inc. Class Action: Levi & Korsinsky Reminds Capricor Investors of the Pending Class Action Lawsuit with a Lead Plaintiff Deadline of September 15, 2025 – CAPR

Key Takeaway: Capricor Therapeutics, Inc. is currently facing a class action lawsuit that alleges securities fraud related to its lead drug candidate, deramiocel, used for treating cardiomyopathy in Duchenne muscular dystrophy. The suit claims that misleading statements were made by the company's defendants regarding the drug's regulatory status, particularly after the FDA issued a Complete Response Letter denying the Biologics License Application due to insufficient evidence of effectiveness. Shareholders who experienced losses during the specified period can seek to become lead plaintiffs in this class action until September 15, 2025.

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CONCERNS & RISKS

  • Capricor is facing a class action lawsuit due to alleged securities fraud.
  • The company received a Complete Response Letter from the FDA denying its Biologics License Application for deramiocel.
  • Capricor's stock price fell significantly from $11.40 to $7.64 following the FDA's decision.

Full Press Release Details

NEW YORK, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ: CAPR) of a class action securities lawsuit.
CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Capricor investors who were adversely affected by alleged securities fraud between October 9, 2024 and July 10, 2025. Follow the link below to get more information and be contacted by a member of our team:
CAPR investors may also contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or by telephone at (212) 363-7500.
CASE DETAILS: According to the complaint, defendants provided investors with material information concerning Capricor’s lead cell therapy candidate drug deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). Defendants’ statements included, among other things, Capricor’s ability to obtain a Biologics License Application (BLA) for deramiocel from the U.S. Food and Drug Administration (FDA). Defendants provided these overwhelmingly positive statements to investors while, at the same time, disseminating false and misleading statements and/or concealing material adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel. On July 11, 2025, Capricor issued a press release announcing it received a Complete Response Letter (CRL) from the FDA denying the BLA specifically citing it did not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data. Further, the CRL referenced outstanding items in the Chemistry, Manufacturing, and Controls section of the application. Following this news, the price of Capricor stock declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.
WHAT'S NEXT? If you suffered a loss in Capricor during the relevant time frame, you have until September 15, 2025 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff.
NO COST TO YOU: If you are a class member, you may be entitled to compensation without payment of any out-of-pocket costs or fees. There is no cost or obligation to participate.
WHY LEVI & KORSINSKY: Over the past 20 years, the team at Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. Our firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
33 Whitehall Street, 17th Floor

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Frequently Asked Questions

What is the Capricor Therapeutics lawsuit about?

The lawsuit concerns alleged securities fraud affecting Capricor investors from October 2024 to July 2025.

How did Capricor's stock price change recently?

The stock price fell from $11.40 to $7.64 following a negative FDA response.

What is the deadline to join the lawsuit?

Investors must request lead plaintiff status by September 15, 2025.

Are there any costs to participate in the class action?

No, participating investors do not incur any out-of-pocket costs.

Who can I contact for more information about the lawsuit?

Contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or call (212) 363-7500.

Last updated: Sep 5, 2025