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Securities law

Capricor Therapeutics, Inc. Faces Securities Lawsuit Over Alleged Fraud

Strategic Insights

— 2 min read

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is facing a class action securities lawsuit alleging the company provided false and misleading statements to investors about its lead cell therapy candidate drug, deramiocel, for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The lawsuit claims that defendants concealed material adverse facts concerning the four-year safety and efficacy data from its Phase 2 HOPE-2 trial study. On July 11, 2025, Capricor issued a press release announcing it received a Complete Response Letter (CRL) from the FDA, which denied the Biologics License Application (BLA) due to the lack of substantial evidence of effectiveness. As a result, the price of Capricor stock declined from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025.

Key Takeaways:

  • The lawsuit was filed against Capricor Therapeutics, Inc. on behalf of shareholders who were allegedly affected by the company's securities fraud between October 9, 2024, and July 10, 2025.
  • The complaint alleges that defendants provided false and misleading statements about Capricor's lead cell therapy candidate drug, deramiocel, including its ability to obtain a Biologics License Application (BLA) for the treatment of cardiomyopathy associated with DMD.
  • The defendants allegedly concealed material adverse facts concerning the 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, which denied the BLA specifically citing it did not meet the statutory requirement for substantial evidence of effectiveness.
  • The price of Capricor stock declined from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, following the news.
  • Investors who suffered losses in Capricor stock during the relevant time frame may be eligible to seek a recovery through the class action lawsuit.
  • Levi & Korsinsky, LLP is representing the investors in the case and has a proven track record of securing significant settlements for aggrieved shareholders.

Statistics:

  • The price of Capricor stock declined by $3.76 per share, or 33.2%, on July 11, 2025.
  • The relevant time frame for the class action lawsuit is from October 9, 2024, to July 10, 2025.
  • The lawsuit seeks to recover losses for shareholders who were allegedly affected by the company's securities fraud.
  • Levi & Korsinsky, LLP has secured hundreds of millions of dollars for aggrieved shareholders in the past 20 years.

Sources:

  • Newsfile Corp. (July 21, 2025)
  • https://zlk.com/pslra-1/capricor-therapeutics-inc-lawsuit-submission-form-2?prid=157561&wire=5&utm_campaign=5
  • https://www.levikorsinsky.com/

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