Capricor Therapeutics, Inc. (CAPR) Stock Drop Lawsuit Investigation

We are investigating whether Capricor Therapeutics, Inc. (NASDAQ: CAPR) misled or provided false statements to investors in violation of federal securities laws. This potential lawsuit seeks to help Capricor Therapeutics, Inc. shareholders recover their losses.

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 cancelled 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. 

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