Capricor Therapeutics Faces Class Action Lawsuit Over Deramiocel Misrepresentations

SAN FRANCISCO, Sept. 3, 2026 /CourierPR/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR) shareholders face continued regulatory and legal challenges following the company's recent announcement of an extended FDA review period for its lead investigational cell therapy, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD). The extended review, set to conclude on November 22, 2026, follows a tumultuous period for the company, which has been embroiled in a securities class action lawsuit.

According to Hagens Berman Sobol Shapiro LLP, a leading plaintiffs' rights law firm, the deadline for investors to submit their claims as lead plaintiff in the ongoing class action is set for September 28, 2026. The lawsuit alleges that Capricor and certain executives made material misrepresentations regarding the clinical trial data and regulatory pathway for deramiocel, failing to disclose changes to the pre-specified statistical analysis plan (SAP) without FDA approval.

On August 24, 2026, the FDA extended the Prescription Drug User Fee Act (PDUFA) target action date for deramiocel, pushing back the decision from August 22, 2026, to November 22, 2026. This extension comes after a controversial July 2026 Advisory Committee meeting and the inclusion of 24-month open-label extension data from the Phase 3 HOPE-3 study. The FDA has classified this submission as a major amendment, indicating the complexity of the case.

The class action lawsuit, which covers the period from December 17, 2025, to July 26, 2026, centers on claims that Capricor and its executives misled investors regarding the efficacy of deramiocel. The lawsuit alleges that the company failed to disclose the unapproved post-hoc modifications to the SAP, leading to the company's share price plummeting by 64% on July 27, 2026, following the FDA's publication of briefing documents.

Capricor's CEO had earlier boasted of "Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy," claiming "HOPE-3 delivered strong and definitive evidence that Deramiocel can meaningfully improve the course of Duchenne muscular dystrophy, demonstrating statistically significant improvements in both skeletal and cardiac function." These claims were a significant factor in the company's share price surge of 370% on December 3, 2025.

Reed Kathrein, a partner at Hagens Berman, stated, "We're focused on investors' losses and uncovering the full scope of how management characterized these trial endpoints and undisclosed modifications." He urged investors who purchased Capricor securities between December 17, 2025, and July 26, 2026, and suffered significant financial losses to submit their claims by September 28, 2026.

Whistleblowers with non-public information are encouraged to contact Hagens Berman for assistance in the investigation or to learn more about the SEC Whistleblower program.