Capricor Therapeutics faces securities fraud allegations, investigation underway.

• Capricor Therapeutics under investigation for securities fraud • Company issued press release about FDA review of Biologics License Application • FDA confirmed intent to hold advisory committee meeting • Investigation concerns unlawful business practices by officers and directors • Investors advised to contact Danielle Peyton for information on joining the class action

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is under investigation for alleged securities fraud, with two prominent law firms, Levi & Korsinsky and Pomerantz LLP, representing investors in class action lawsuits. The investigations stem from Capricor's Biologics License Application (BLA) for deramiocel, an investigational cell therapy for cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

According to the lawsuits, Capricor and its officers provided investors with false and misleading statements about the drug's potential and its ability to obtain FDA approval. The lawsuits allege that Capricor concealed material adverse facts, including the results of its Phase 2 HOPE-2 trial study, which were unfavorable to the drug's efficacy and safety.

On July 11, 2025, Capricor issued a press release announcing that the FDA had denied the BLA for deramiocel, citing a lack of substantial evidence of effectiveness and the need for additional clinical data. This news led to a significant decline in Capricor's stock price, falling from $11.40 per share on July 10, 2025 to $7.64 per share on July 11, 2025.

Investors who suffered losses during the relevant time frame (October 9, 2024 to July 10, 2025) are advised to contact the law firms for more information. The deadline for requesting that the Court appoint a lead plaintiff is September 15, 2025.

References:
[1] https://www.morningstar.com/news/pr-newswire/20250815ny52151/capricor-therapeutics-inc-sued-for-securities-law-violations-investors-should-contact-levi-korsinsky-for-more-information-capr
[2] https://www.prnewswire.com/news-releases/investor-alert-pomerantz-law-firm-investigates-claims-on-behalf-of-investors-of-capricor-therapeutics-inc---capr-302527388.html
[3] https://www.morningstar.com/news/globe-newswire/9512215/levi-korsinsky-notifies-shareholders-of-capricor-therapeutics-inccapr-of-a-class-action-lawsuit-and-an-upcoming-deadline