Investors Advised of Class Action Lawsuit Against Capricor Therapeutics by Levi & Korsinsky

Levi & Korsinsky Notifies Capricor Therapeutics Investors

Levi & Korsinsky, LLP recently issued a notice to investors of Capricor Therapeutics, Inc. (NASDAQ: CAPR), informing them about a class action lawsuit related to alleged securities fraud. The lawsuit aims to recover losses sustained by shareholders during a period where the company’s stock was affected by misleading information.

Understanding the Class Action Lawsuit

The lawsuit pertains to Capricor’s investors who experienced losses within the timeframe of October 9, 2024, to July 10, 2025. Throughout this period, the company reportedly provided misleading statements regarding its lead drug candidate, deramiocel, which is intended for the treatment of cardiomyopathy associated with Duchenne Muscular Dystrophy (DMD). According to the complaints, these statements suggested that Capricor could successfully obtain a Biologics License Application (BLA) from the FDA, despite undercurrents of negative information regarding the drug’s safety and efficacy.

When investigating the allegations, it became evident that Capricor misrepresented data from its Phase 2 HOPE-2 trial. This trial's outcomes—which were crucial to validating the drug’s effectiveness—were downplayed, deceiving potential investors.

On July 11, 2025, the company faced a significant setback when it received a Complete Response Letter (CRL) from the FDA. The CRL explicitly denied the BLA, highlighting that the application did not meet the regulatory requirements, including the need for more clinical data. Consequently, following this announcement, Capricor’s stock plummeted from $11.40 to $7.64—a substantial loss, especially for investors who were unaware of the underlying issues surrounding the company’s claims.

Next Steps for Affected Investors

For any individual who experienced financial loss during the specified period, there is a critical deadline approaching. Investors have until September 15, 2025, to file for lead plaintiff status in the class action lawsuit. Being named as a lead plaintiff is not necessary for investors to reclaim losses, but it is an essential step for those looking to take an active role in the proceedings. Legal consultations can be arranged at no cost to the affected persons, offering a no-obligation way to seek compensation.

Why Choose Levi & Korsinsky?

Levi & Korsinsky has a longstanding reputation in securities litigation, having recovered significant amounts for investors over the last 20 years. Their commitment to high-stakes legal battles makes them a formidable representative in complex securities cases. The firm is staffed with a professional team of over 70 experts dedicated to serving clients and pursuing justice on their behalf.

With seven consecutive years in the Top 50 Report by ISS Securities Class Action Services, Levi & Korsinsky is recognized as one of the premier practices in the U.S., further assuring investors that they have the right team advocating for their rights.

Conclusion

The unfolding situation involving Capricor Therapeutics underscores the importance of vigilance among investors in the biotech sector. With allegations of securities fraud now leading to a formal class action lawsuit, affected shareholders are encouraged to take prompt action. For those interested, they can reach out to Joseph E. Levi, Esq. at Levi & Korsinsky for more details about their legal options and next steps in the lawsuit.

By staying informed and seeking legal counsel, investors can ensure their voices are heard amid the complexities of corporate actions and legal proceedings.