Shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company’s Biologics License Application for its lead cell therapy candidate, Deramiocel, claiming that the application “does not meet the statutory requirement for substantial evidence of effectiveness” and lacks “certain outstanding items.” Gibbs Mura is investigating a potential Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Class Action Lawsuit on behalf of shareholders who lost money in Capricor Therapeutics, Inc.

What Should Capricor Therapeutics, Inc. Investors Do?

If you invested in Capricor Therapeutics, Inc., visit our Capricor Therapeutics, Inc. Investigation webpage or call us at (888) 410-2925 to get more information about how you may be able to recover your losses. Our investigation concerns whether Capricor Therapeutics, Inc. has violated federal securities laws by providing false or misleading statements to investors.

What is the Capricor Therapeutics, Inc. (CAPR) Lawsuit Investigation About?

On July 11, 2025, Capricor Therapeutics announced that the FDA rejected the company’s Biologics License Application (BLA) for its cell therapy candidate, Deramiocel, citing that the application “does not meet the statutory requirement for substantial evidence of effectiveness” and lacks “certain outstanding items.” The FDA’s Complete Response Letter specified that the deficiencies were in the BLA’s Chemistry, Manufacturing, and Controls section, and emphasized a need for additional clinical data.

Following this news, shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on July 11, 2025, causing harm to investors.

Previously, on May 5, 2025, Capricor announced that the FDA “confirmed its intent to hold an advisory committee meeting” following the completion of a mid-cycle review meeting for the company’s BLA for Deramiocel. Following the announcement, Capricor’s stock fell over 29% on May 6, 2025. Then, on June 20, 2025, STAT reported that the director of the FDA’s Center for Biologics Evaluation and Research canceled the advisory committee meeting regarding Deramiocel, due to being “skeptical of the treatment.” In the wake of the report, Capricor’s stock fell over 30% on June 20, 2025.

About Gibbs Mura

Gibbs Mura represents investors nationwide in securities litigation. The firm has recovered over a billion dollars for its clients against some of the world’s largest corporations, and our attorneys have received numerous honors for their work, including “Best Lawyers in America,” “Top Plaintiff Lawyers in California,” “California Lawyer Attorney of the Year,” “Class Action Practice Group of the Year,” “Consumer Protection MVP,” and “Top Women Lawyers in California.”

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