Capricor Therapeutics, Inc. Faces Securities Lawsuit Over Alleged Fraud

Strategic Insights -

A class action securities lawsuit was filed against Capricor Therapeutics, Inc. due to alleged securities fraud between October 9, 2024, and July 10, 2025. The company's lead cell therapy candidate drug deramiocel for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD) was at the center of the alleged misstatements. According to the complaint, defendants provided false and misleading statements concerning the four-year safety and efficacy data from its Phase 2 HOPE-2 trial study of deramiocel. The lawsuit seeks to recover losses of shareholders who were adversely affected by the alleged securities fraud.

Key Takeaways:

  • The lawsuit, filed against Capricor Therapeutics, Inc., alleges securities fraud between October 9, 2024, and July 10, 2025.
  • The company allegedly provided false and misleading statements concerning 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 of deramiocel.
  • The company received a Complete Response Letter (CRL) from the FDA on July 11, 2025, denying the Biologics License Application (BLA) specifically citing it did not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.
  • 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 of the FDA's decision.
  • The lawsuit seeks to recover losses of shareholders who were adversely affected by the alleged securities fraud.

Statistics:

  • The alleged securities fraud took place between October 9, 2024, and July 10, 2025.
  • The price of Capricor stock declined by $3.76 per share following the news of the FDA's decision, from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025.
  • 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 of deramiocel.
  • The company's lead cell therapy candidate drug deramiocel is being developed for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Sources:

  • https://zlk.com/pslra-1/capricor-therapeutics-inc-lawsuit-submission-form-2?prid=164852&wire=5&utm_campaign=18
  • https://www.newsfilecorp.com/release/264844