Capricor Therapeutics, Inc. Faces Securities Lawsuit Over Alleged Fraud

Strategic Insights -

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 of deramiocel. On July 11, 2025, Capricor issued a press release announcing it received a Complete Response Letter (CRL) from the FDA denying the Biologics License Application (BLA) for deramiocel. Following this news, the price of Capricor stock declined significantly.

Key Takeaways:

  • The lawsuit was filed against Capricor Therapeutics, Inc. and seeks to recover losses of shareholders who were adversely affected by alleged securities fraud between October 9, 2024 and July 10, 2025.
  • The complaint alleges that defendants provided false and misleading statements to investors about the safety and efficacy data of deramiocel, while concealing material adverse facts.
  • Defendants' statements included Capricor's ability to obtain a Biologics License Application (BLA) for deramiocel from the U.S. Food and Drug Administration (FDA).
  • Capricor stock price declined from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025, following the announcement of the FDA's Complete Response Letter (CRL).
  • Levi & Korsinsky, LLP, a nationally-recognized securities litigation firm, is representing the lead plaintiff in the case.
  • The firm has secured hundreds of millions of dollars for aggrieved shareholders and has established a track record of winning high-stakes cases.
  • Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States for seven years in a row.

Statistics:

  • Date range of alleged securities fraud: October 9, 2024 to July 10, 2025.
  • Decline in Capricor stock price: $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.
  • Number of shares allegedly affected: Unknown, as the lawsuit seeks to recover losses of all shareholders who were adversely affected by the alleged securities fraud.
  • Size of recovery sought: Unknown, as the lawsuit is still in the early stages and has not yet been settled or litigated.

Sources:

  • Newsfile Corp. - September 9, 2025
  • https://zlk.com/pslra-1/capricor-therapeutics-inc-lawsuit-submission-form-2?prid=166220&wire=5&utm_campaign=3
  • https://www.youtube.com/watch?v=WkeFApDBai4
  • Levi & Korsinsky, LLP