Hagens Berman Alerts Investors to Capricor's FDA Review Extension and Ongoing Securities Class Action

Hagens Berman's Alert on Capricor Therapeutics

Hagens Berman Sobol Shapiro LLP, a prominent plaintiffs' rights law firm, has recently notified investors in Capricor Therapeutics, Inc. (NASDAQ: CAPR) regarding important developments concerning the company's FDA review and ongoing securities litigation. As of August 28, 2026, the law firm made it clear that September 28, 2026, serves as a critical lead plaintiff deadline for individuals impacted by the ongoing class action lawsuit.

FDA Review Extension for Deramiocel

On August 24, 2026, Capricor disclosed that the U.S. Food and Drug Administration (FDA) extended the review timeline for its lead investigational biologic drug, deramiocel, which is designed to treat Duchenne muscular dystrophy (DMD). Originally set to be decided by August 22, 2026, the new expected target action date is now November 22, 2026. This extension arose following a tumultuous Advisory Committee meeting from July 2026, alongside submissions detailing open-label extension data from the Phase 3 HOPE-3 study.

Background of the Class Action

The lawsuit against Capricor involves allegations that the company and certain executives made misleading statements about the clinical trial data related to deramiocel. These allegations assert that they failed to disclose critical modifications to the statistical analysis plan, which were made without prior approval from the FDA before the resubmission of the Biologics License Application (BLA). This lack of transparency has fueled the legal claims against the company.

The class action lawsuit pertains to the trading period between December 17, 2025, and July 26, 2026. Following the announcement of positive results from the HOPE-3 trial on December 3, 2025, when Capricor reported gains in skeletal and cardiac function, its stock price surged by an astonishing 370%. However, the situation reversed dramatically on July 27, 2026, when the FDA revealed that the necessary efficacy endpoints for deramiocel had not been met. This led to a staggering 64% drop in stock price, causing significant financial losses for investors.

Current Legal Options for Affected Investors

Hagens Berman is encouraging investors who acquired Capricor securities during the specified class period and suffered significant losses to consider taking action. Interested parties have until September 28, 2026, to file for lead plaintiff status in the ongoing securities class action lawsuit. It's important to note that they do not need to take on lead plaintiff status to potential recover in any prospective settlement or award. Individuals seeking information on the legal options available to them are invited to visit Hagens Berman's dedicated page.

Additionally, whistleblowers possessing non-public information about Capricor are urged to step forward, as valuable insights could assist in the ongoing investigation into the company's activities. Under the SEC Whistleblower program, they may be eligible for considerable financial rewards based on any successful recovery.

About Hagens Berman

Hagens Berman is known for its commitment to pursuing corporate accountability across various legal landscapes. The firm is dedicated to ensuring justice for investors, consumers, and employees who have been wronged by corporate misconduct. They have a successful track record, having secured over $2.9 billion for their clients. For additional updates and news, you can follow the firm on social media at @ClassActionLaw.

This update serves as a crucial reminder for investors in Capricor Therapeutics, who need to remain aware of their legal rights in light of these recent developments.