Investors of Capricor Therapeutics Face Class Action Lawsuit Over Alleged Securities Fraud

Class Action Filed Against Capricor Therapeutics, Inc.

On August 1, 2025, Levi & Korsinsky, LLP announced a class action lawsuit against Capricor Therapeutics, Inc. (NASDAQ: CAPR), targeting the company for purported securities fraud that allegedly affected investors between October 9, 2024, and July 10, 2025. The lawsuit intends to recover losses incurred by shareholders who may have been misled by the company's representations regarding its leading drug candidate, deramiocel, aimed at treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Case Overview

The heart of the lawsuit revolves around statements made by Capricor regarding its ability to secure a Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA) for deramiocel. According to the complaint, the defendants allegedly provided misleading information while failing to disclose critical adverse facts, particularly related to the four-year safety and efficacy data from its Phase 2 HOPE-2 clinical trial on the drug. These omissions and inaccuracies were presented alongside overly optimistic communications about the therapy's prospects.

The situation escalated on July 11, 2025, when Capricor issued a press release confirming receipt of a Complete Response Letter (CRL) from the FDA that explicitly refused the BLA. The letter cited the lack of substantial evidence supporting deramiocel's effectiveness and indicated that additional clinical data would be necessary. Following this announcement, Capricor’s stock price plummeted from $11.40 per share on July 10 to $7.64 the next day, reflecting a significant loss for investors.

What Investors Should Know

As stated in the legal notice, anyone who suffered losses in Capricor during the stipulated time frame is encouraged to connect with Levi & Korsinsky before September 15, 2025, to request appointment as lead plaintiff. Importantly, investors do not need to be the lead plaintiff to participate in any potential recovery from the class action.

Participation in the lawsuit comes at no financial cost to the class members. If you qualify, you may receive compensation without the need to pay out-of-pocket expenses or fees, thus providing an opportunity for those who have been negatively impacted to recuperate some of their investments without financial risk.

Why Choose Levi & Korsinsky?

Levi & Korsinsky boasts a proven track record in handling complex securities litigation. With over two decades of experience, the firm has secured hundreds of millions of dollars for aggrieved shareholders, solidifying its position as one of the leading securities litigation firms in the United States. Constantly ranked among the top firms by ISS Securities Class Action Services, it has dedicated resources and a skilled team to support its clients efficiently.

For those wishing to learn more about this particular class action or if you want to understand your rights as an investor, you can contact Joseph E. Levi, Esq. or Ed Korsinsky, Esq. at Levi & Korsinsky, LLP.

Their office is located at 33 Whitehall Street, 17th Floor, New York, NY 10004. You can reach them by email at [email protected] or by calling (212) 363-7500 for further inquiries.

Investors should stay vigilant and informed, particularly in the wake of such significant corporate events, to ensure they can take swift action to protect their financial stakes.