Investors File Class Action Against Capricor Therapeutics Over Alleged Securities Fraud

Investors Seek Justice in Class Action Against Capricor Therapeutics

In a significant legal development, investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) are uniting to file a class action lawsuit, driven by claims of securities fraud that reportedly caused substantial financial losses. This action, spearheaded by Levi & Korsinsky, LLP, serves as a direct response to misleading information provided by the company regarding its lead drug candidate designed for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Background of Capricor's Controversies

The lawsuit is focused on the period between October 9, 2024, and July 10, 2025, a time frame marked by heightened investor optimism fueled by Capricor's communications. The company had touted its drug deramiocel as a potential game-changer in the medical field, claiming it was on track to receive a Biologics License Application (BLA) from the U.S. Food and Drug Administration (FDA). However, as the events unfolded, it became evident that the situation was not as positive as Capricor had portrayed.

Key Allegations Against Capricor

Investors allege that Capricor's management misrepresented critical safety and efficacy data regarding deramiocel, especially stemming from its Phase 2 study known as HOPE-2. Although they issued optimistic statements about the approval prospects, the company was simultaneously concealing adverse facts, including serious doubts about the drug's effectiveness and additional data requirements from the FDA.

The turning point came on July 11, 2025, when Capricor announced that it had received a Complete Response Letter (CRL) from the FDA, which explicitly stated that the company did not meet the required statistical evidence of effectiveness for the approval of deramiocel. Furthermore, the FDA highlighted unresolved issues regarding the manufacturing and controls of the submitted application. The news led to a steep drop in Capricor's stock price, plummeting from $11.40 to $7.64 within a mere 24 hours, deeply affecting investor confidence.

The Legal Process and What to Expect

As the class action progresses, investors are encouraged to come forward and participate in the recovery process. Those who experienced financial losses during the specified timeline have until September 15, 2025, to request their appointment as lead plaintiffs. This class action provides a window for investors to reclaim their lost funds without incurring legal costs, as participation in the action will incur no out-of-pocket expenses for class members.

Levi & Korsinsky's Role

Levi & Korsinsky, LLP boasts a solid reputation in the realm of securities litigation. With over two decades of experience and a history of securing hundreds of millions of dollars for shareholders, the firm is prepared to guide investors through the intricacies of this legal battle. They have consistently ranked among the top securities litigation firms nationally, underscoring their commitment to advocating for investors’ rights.

As developments unfold in the case, it will be crucial for affected investors to stay informed about their rights and options. By joining forces, they not only seek individual recovery but also aim to hold Capricor accountable for the alleged deception that has shaken investor trust.

For further information or to proceed with claims related to this class action, investors can contact Levi & Korsinsky directly via their dedicated channels. The path to justice may be long, but with collective action, affected investors can amplify their voices and seek the redress they deserve.