Recent Updates
Recently added Catalysts
CAPR Negative Sentiment Score: 25/100

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 class action lawsuit alleging securities fraud concerning the misleading statements about its lead therapy candidate, deramiocel. Investors have been invited to contact The Gross Law Firm for potential lead plaintiff status. The lawsuit follows a Complete Response Letter from the FDA that denied the company's application for deramiocel due to insufficient evidence of effectiveness, resulting in a significant decline in CAPR's stock price. Shareholders have until September 15, 2025, to register for participation in the class action case.

Market Sentiment Analysis

CONCERNS & RISKS

  • Capricor faced allegations of securities fraud related to misleading information about its lead drug candidate's approval status.
  • The company received a Complete Response Letter from the FDA, denying its Biologics License Application, which included requests for additional clinical data.
  • The stock price dropped significantly following the FDA's announcement, indicating investor loss and market reaction to the negative news.

Full Press Release Details

NEW YORK, Aug. 18, 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=161670&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.
15 West 38th Street, 12th floor
Phone: (646) 453-8903

Tags

Frequently Asked Questions

What is the class period for the Capricor Therapeutics case?

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

What allegations are made against Capricor Therapeutics?

The allegations involve misleading information about the efficacy of deramiocel.

What happened after the FDA's Complete Response Letter on July 11, 2025?

Capricor's stock price dropped from $11.40 to $7.64 per share.

What is the deadline to register for the class action?

The deadline to register is September 15, 2025.

Are there any costs to participate in this case?

There is no cost or obligation to participate in the class action.

Last updated: Aug 18, 2025