Capricor Therapeutics Investors Alerted for Class Action Lawsuit Before Deadline

Capricor Therapeutics Investors Urged to Join Class Action

Investors of Capricor Therapeutics, Inc. (NASDAQ: CAPR) are receiving crucial notifications concerning a class action lawsuit led by Hagens Berman Sobol Shapiro LLP, a national plaintiffs' rights law firm renowned for its adept representation in securities cases. These investors, who have experienced substantial financial losses, have until September 28, 2026, to act and potentially take on the role of lead plaintiff in this ongoing legal matter.

Recent FDA Developments

Recently, the U.S. Food and Drug Administration (FDA) decided to extend its review period for Capricor’s Biologics License Application (BLA) for its key investigational cell therapy, deramiocel, which targets Duchenne muscular dystrophy (DMD). Originally set for decision by August 22, 2026, this date has been pushed back to November 22, 2026. This delay raises further concern about regulatory compliance and transparency related to the company’s disclosures.

Overview of the Class Action

The securities class action focuses on a significant period, from December 17, 2025, to July 26, 2026. It concerns allegations that Capricor and its executives provided materially false and misleading statements surrounding clinical trial data and modifications to its pre-specified statistical analysis plans (SAP). The firm's legal representatives urge affected investors to exchange their experience with the firm as they prepare their case.

The Core Allegations

The lawsuit posits that Capricor made unapproved changes to its pre-specified statistical analysis plan prior to resubmitting its BLA. Allegations note that the company did not disclose these changes nor the negative implications they carried for the clinical efficacy data on deramiocel. This alleged lack of transparency could have misled investors about the drug's potential and the company's business practices.