Gross Law Firm Initiates Class Action Against Capricor Therapeutics Following FDA Rejection

What's Happening?

The Gross Law Firm has announced a class action lawsuit against Capricor Therapeutics, Inc. following the FDA's rejection of its Biologics License Application (BLA) for the drug deramiocel. The drug was intended for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy. The FDA issued a Complete Response Letter (CRL) citing insufficient evidence of effectiveness and the need for additional clinical data. The CRL also highlighted unresolved issues in the Chemistry, Manufacturing, and Controls section of the application. This news led to a significant drop in Capricor's stock price, from $11.40 to $7.64 per share. Shareholders who purchased shares between October 9, 2024, and July 10, 2025, are encouraged to join the lawsuit.

Why It's Important?

The lawsuit against Capricor Therapeutics underscores the critical importance of transparency and accuracy in corporate communications, especially in the pharmaceutical industry. The FDA's rejection and subsequent stock price drop highlight the financial risks associated with drug development and approval processes. Investors who relied on Capricor's statements may have suffered significant financial losses, prompting legal action. This case could set a precedent for how companies communicate trial results and regulatory feedback, potentially influencing investor relations and corporate governance practices across the industry.

What's Next?

Shareholders have until September 15, 2025, to register for the class action. Those who join will be enrolled in a portfolio monitoring software to receive updates on the case. The Gross Law Firm aims to recover losses for investors affected by Capricor's alleged misleading statements. The outcome of this lawsuit could impact Capricor's future business operations and investor confidence. Additionally, it may lead to increased scrutiny of pharmaceutical companies' communications with investors, potentially affecting how they report trial results and regulatory interactions.