Lawsuit Alert: Investors who lost money with shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) should contact the Shareholders Foundation

An investor, who purchased shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR), filed a lawsuit over alleged violations of Federal Securities Laws by Capricor Therapeutics, Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) have certain options and for certain investors are short and strict deadlines running. Deadline: September 15, 2025. NASDAQ: CAPR investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

San Diego, CA based Capricor Therapeutics, Inc., a clinical-stage biotechnology company, engages in the development of transformative cell and exosome-based therapeutics for treating duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the United States.

On May 5, 2025, Capricor Therapeutics, Inc. (NASDAQ: CAPR) announced that after "the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy", the FDA had "confirmed its intent to hold an advisory committee meeting" in connection with the BLA.

On June 20, 2025 the publication STAT News reported that the new head of the relevant FDA unit had canceled the advisory committee meeting for deramiocel due to uncertainty about the drug's efficacy and safety.

Then, on July 11, 2025, Capricor Therapeutics, Inc. (NASDAQ: CAPR) announced it received a Complete Response Letter from the FDA denying Capricor's Biologics License Application for deramiocel, citing it did not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.

Shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) declined from $23.40 per share on October 15, 2024, to as low as $6.19 per share on July 21, 2025.

The plaintiff claims that between October 9, 2024 and July 10, 2025, the 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. 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, and that the 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, causing Plaintiff and other shareholders to purchase Capricor's securities at artificially inflated prices.

Those who purchased shares of Capricor Therapeutics, Inc. (NASDAQ: CAPR) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.