Investors of Capricor Therapeutics Have Class Action Lawsuit Opportunity Before September Deadline

Capricor Therapeutics: An Urgent Call for Investors to Act

As we approach the significant deadline of September 28, 2026, investors of Capricor Therapeutics, Inc. (NASDAQ: CAPR) are being urged to consider leading a shareholder class action lawsuit. This opportunity arises amidst ongoing scrutiny following substantial losses incurred by shareholders due to misleading information regarding the company's lead investigational cell therapy aimed at treating Duchenne muscular dystrophy (DMD).

Background on Capricor Therapeutics

Capricor is a biotechnology company recognized for its innovative approach towards addressing severe health conditions like DMD. However, recent communications have raised concerns about the integrity of their clinical trial data and the regulatory processes governing their product pipeline.

On August 24, 2026, Capricor disclosed that the U.S. Food and Drug Administration (FDA) had extended its review period for the company’s Biologics License Application (BLA) for its lead therapy, deramiocel, originally scheduled for a decision on August 22, 2026. The new action date is November 22, 2026. This extension was classified as a major amendment following a turbulent Advisory Committee meeting held in July, during which critical issues regarding their trial results were raised.

Key Allegations Against Capricor

Investors are now faced with the implications of Capricor’s decision to make post-hoc modifications to its statistical analysis plan (SAP). Allegations state that these changes were made without the agreement of the FDA, potentially undermining the validity of their submitted data and the foundation of their claims regarding deramiocel’s efficacy.

The lawsuit encapsulates a timeline of misleading statements: the firm previously touted positive results from its Phase 3 HOPE-3 study, leading to a 370% increase in share price within days. However, the FDA's publication of briefing documents on July 27, 2026, revealed stark discrepancies in the reported efficacy of deramiocel, leading to a catastrophic plunge in stock value, wiping out approximately 64% in a single day.

Actions for Affected Investors

Hagens Berman Sobol Shapiro LLP, a prominent plaintiffs' rights law firm, is spearheading the organization of this class action lawsuit. They emphasize urgency for investors who sustained significant financial losses between December 17, 2025, and July 26, 2026, to step forward by the September deadline. There is no requirement to seek lead plaintiff status to be eligible for any potential recovery made through the lawsuit.

To participate or gain further insight into this situation, investors are encouraged to contact Hagens Berman directly via their website (www.hbsslaw.com/capr) or calling 844-916-0895.

In addition, those who have non-public information regarding Capricor may also wish to explore their options through the SEC Whistleblower program. This program offers potential financial rewards of up to 30% for individuals providing original information that results in successful SEC enforcement action.

Conclusion

As the deadline looms, it is crucial for affected investors to recognize this moment as a chance to reclaim their losses through collective legal action. The allegations against Capricor highlight the vital role of corporate transparency and accountability, especially in the high-stakes landscape of biotechnology investment. Investors should act promptly to ensure their voices are heard and rights protected in the judicial process.