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Capricor Therapeutics, Inc. Securities Fraud Class Action Lawsuit Pending: Contact The Gross Law Firm Before September 15, 2025 to Discuss Your Rights – CAPR

Key Takeaway: Capricor Therapeutics, Inc. is facing a securities fraud class action lawsuit following a Complete Response Letter (CRL) from the FDA, which denied the biologics license application for its lead therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy. The lawsuit alleges that the company provided misleading information about the drug’s efficacy while concealing adverse safety data from a clinical trial. Following the FDA's decision, the company's stock plummeted, prompting shareholders to consider joining the class action. The deadline for investors to register for participation in the lawsuit is set for September 15, 2025.

Market Sentiment Analysis

CONCERNS & RISKS

  • Capricor received a Complete Response Letter (CRL) from the FDA, denying the BLA for deramiocel due to insufficient evidence of effectiveness.
  • The company's stock price dropped significantly after the announcement, falling from $11.40 to $7.64 per share.
  • Investors were allegedly misled by false and misleading statements regarding the safety and efficacy data of deramiocel.

Full Press Release Details

NEW YORK, July 21, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Capricor Therapeutics, Inc. (NASDAQ: CAPR).
Shareholders who purchased shares of CAPR during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.
CLASS PERIOD: October 9, 2024 to July 10, 2025
ALLEGATIONS: 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.
DEADLINE: September 15, 2025 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/capricor-loss-submission-form/?id=157205&from=3
NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of CAPR during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is September 15, 2025. There is no cost or obligation to you to participate in this case.
WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.
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Frequently Asked Questions

What is the class period for Capricor Therapeutics?

The class period for Capricor Therapeutics is from October 9, 2024, to July 10, 2025.

What allegations are made against Capricor Therapeutics?

The allegations involve false statements about deramiocel's FDA approval and misleading efficacy data.

When is the deadline to register for the class action?

The deadline to register for the class action is September 15, 2025.

What happens after I register as a shareholder?

After registration, you'll receive updates through portfolio monitoring software throughout the case.

Do I need to be a lead plaintiff to recover losses?

No, you do not need to be a lead plaintiff to participate in any recovery.

Last updated: Jul 21, 2025