#USA #Class Action #San Francisco #securities lawsuit #Capricor Therapeutics

Urgent Notice for Capricor Therapeutics Investors

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is currently under scrutiny as investors face substantial losses linked to the firm’s recent regulatory challenges. Hagens Berman Sobol Shapiro LLP, a prominent plaintiffs’ rights law firm, is alerting affected investors about the critical deadline approaching on September 28, 2026, to become lead plaintiffs in a class action lawsuit.

Background and Current Status

Recent developments have seen the U.S. Food and Drug Administration (FDA) extend its review period for Capricor’s Biologics License Application (BLA), crucial for their investigational therapy, deramiocel, which targets Duchenne muscular dystrophy (DMD). Originally set for a decision on August 22, 2026, the new extended date is November 22, 2026. This extension has raised concerns about the regulatory journey of the company and prompted investors to reassess their positions.

Capricor first gained positive attention in December 2025 with declarations of promising trial results from the HOPE-3 study. Following this announcement, the company's stock saw a significant surge, increasing by 370% in a matter of days. Nevertheless, investor optimism quickly turned to despair when the FDA later indicated that recent modifications to their Statistical Analysis Plan (SAP) were made without prior agreement, ultimately leading to the revelation that the study did not meet its efficacy endpoints. This news precipitated a drastic 64% stock price drop in July 2026, which has heavily impacted shareholder equity.

Legal Implications

The class action lawsuit targets not just the detrimental changes in stock value but alleges that misleading statements by Capricor's executives regarding clinical trial outcomes significantly influenced investor decisions. Investors who purchased Capricor shares within the class period from December 17, 2025, to July 26, 2026, and realized losses, are encouraged to participate in the lawsuit.

Hagens Berman has begun investigating potential misleading disclosures which contributed to investors' financial damage. The firm asserts that Capricor's management failed to communicate critical changes affecting the study's outcomes, implicating them in potential securities fraud. Reed Kathrein, a partner at Hagens Berman, highlighted the gravity of the situation, emphasizing that affected investors can leverage their losses to seek accountability from the company.

What Affected Investors Should Do

Investors who believe they have suffered losses are facing a critical juncture: they must act before the September 28 deadline to assure their voice is heard in the pending class action. Participation does not necessitate achieving lead plaintiff status, allowing many to share in possible legal recoveries.

Parents and family members of patients suffering from DMD, who were financially impacted by these developments, are encouraged to consider how they can contribute to the lawsuit. Investors can learn more or submit their claims through Hagens Berman by visiting their website, where comprehensive resources are available for understanding both the legal process and potential recovery.

Conclusion

This case serves as a significant reminder of the importance of regulatory transparency within the biotech industry and the fiduciary responsibilities held by corporate executives. As the situation with Capricor unfolds, affected investors are urged to remain vigilant and consider their legal options. More information about the ongoing investigation and updates on the lawsuit can be found on Hagens Berman's dedicated page for Capricor Therapeutics investors.