#USA #New York #Class Action #Pomerantz LLP #Capricor Therapeutics

Important Investor Alert: Class Action Lawsuit Against Capricor Therapeutics

Pomerantz LLP, a prominent law firm known for its expertise in securities class litigation, has announced significant developments for investors impacted by recent events surrounding Capricor Therapeutics, Inc. (NASDAQ: CAPR). On September 17, 2026, the firm confirmed that a class action lawsuit has been filed against the company, prompting affected investors to carefully consider their legal options.

Overview of the Class Action Lawsuit

The class action centers on allegations that Capricor and certain executives may have engaged in securities fraud and other unlawful business practices that could have misled investors. Individuals who purchased or acquired shares of Capricor securities during the specified class period are encouraged to act quickly, as they have until September 28, 2026, to petition the court to be appointed as Lead Plaintiff. Interested parties can contact Danielle Peyton at Pomerantz LLP via email or phone to seek further information. Providing details such as mailing address and contact numbers will be crucial for those looking to join the lawsuit.

Background on Capricor's Regulatory Challenges

In late 2024, Capricor took a significant step by filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for its cell therapy product, Deramiocel, aimed at treating Duchenne muscular dystrophy. However, the company faced regulatory setbacks when, in July 2025, the FDA issued a Complete Response Letter indicating that additional clinical data was necessary to support the BLA's claims. Capricor asserted that it had addressed the issues raised by the FDA by March 2026, but complications would soon arise.

Recent Developments and Market Impact

On July 27, 2026, just before the market opened, the FDA published briefing documents outlining concerns regarding Capricor's submission for the BLA. The FDA criticized a change made to the statistical analysis plan (SAP) that had not been reviewed prior to submission. This change led to a substantial drop in Capricor's stock price—64%—following the release of this information. The briefing included the FDA's assertion that Capricor's analyses lacked scientific justification, deeming them exploratory and unreliable.

The situation became even more dire for the company when, on July 29, 2026, an advisory committee meeting ultimately led to a non-binding vote against recommending the efficacy of Deramiocel for treating DMD-related cardiomyopathy. Following this adverse news, Capricor's stock price fell another 36%, indeed alarming investors and raising further questions about the company's business practices.

Pomerantz's Legacy in Class Action Cases

Pomerantz LLP has a longstanding tradition of advocating for victims of corporate misconduct and securities fraud. Founded by Abraham L. Pomerantz, a pioneer in the class action bar, the firm has recovered substantial damages on behalf of investors and continues to uphold its commitment to protecting the rights of shareholders. With offices in several major cities worldwide, Pomerantz is well-equipped to handle complex litigation involving securities and antitrust issues.

Call to Action for Investors

Investors impacted by this situation have a crucial opportunity to reclaim losses by joining the class action lawsuit. For those wishing to participate, timely action is essential. Promptly contacting Pomerantz LLP ensures that your interests are represented in this ongoing legal battle. Those affected by these stock fluctuations should remain vigilant and proactive in overseeing their investments and potential participation in this class action suit.

For further details, please visit Pomerantz LLP's website or reach out directly to Danielle Peyton at the provided contact information. Understanding your rights as an investor is crucial in navigating these turbulent circumstances surrounding Capricor Therapeutics.