Class Action Sued Over Capricor Therapeutics' Deramiocel Data Controversy

On September 11, 2026, a securities class action lawsuit was filed against Capricor Therapeutics, Inc., a biotechnology company listed on the Nasdaq Global Select Market under the ticker CAPR. The lawsuit, brought by the law firm Kahn Swick & Foti, LLC, seeks to recover losses for investors who purchased Capricor securities between December 17, 2025, and July 26, 2026.

According to the complaint, Capricor and certain of its executives are accused of failing to disclose material information during the class period. The lawsuit alleges that the company made changes to the pre-specified statistical analysis plan (SAP) for its lead product candidate, Deramiocel, without proper disclosure. The U.S. Food and Drug Administration (FDA) published briefing documents ahead of its July 29 advisory committee meeting, which reviewed the Biologics License Application (BLA) for Deramiocel. The FDA found that the changes to the SAP were not submitted for review prior to the BLA submission and were not discussed, rendering the final SAP post-hoc and exploratory.

The FDA's concerns were significant, as the benefit-risk profile for Deramiocel appeared unfavorable due to the lack of evidence supporting its effectiveness. This news caused Capricor's stock to plummet by 64% on July 27, 2026, closing at $7.00 per share, a $12.70 drop from the previous day's closing price.

Kahn Swick & Foti, LLC, a boutique securities litigation law firm, is known for representing investors in complex securities cases. The firm's partners, including former Louisiana Attorney General Charles C. Foti, Jr., have a track record of significant recoveries for investors.

The lawsuit highlights the importance of transparency and compliance in the biotechnology sector, particularly in the context of FDA regulatory processes. Investors are advised to remain vigilant and seek legal counsel if they believe they have suffered losses due to the company's alleged misrepresentations.