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Class Action Lawsuit Against Capricor Therapeutics

In a significant development for investors, Pomerantz Law Firm has issued an alert regarding a class action lawsuit filed against Capricor Therapeutics, Inc. (NASDAQ: CAPR). This legal action arises from allegations of securities fraud and other unlawful business practices involving the company and certain members of its management. As part of this lawsuit, investors who have incurred losses on their Capricor investments are being urged to engage with Pomerantz to discuss their potential participation in the class action.

Background of the Case

The class action centers on the question of whether Capricor and its officials engaged in fraudulent activities that misled investors, leading to significant financial losses. The defendants are understood to include key officers and directors of the company. Those who have acquired Capricor securities during the Class Period are particularly encouraged to act. Interested individuals have until September 28, 2026, to contact the court and seek appointment as Lead Plaintiff in this matter. For those wanting to take part or gather further information, the Pomerantz Law Firm has provided contact details for inquiries, including an email address and a toll-free number for ease of access.

Recent Developments

The lawsuit is the culmination of a series of events surrounding Capricor's attempts to secure FDA approval for its product, Deramiocel, designed to treat Duchenne muscular dystrophy (DMD). In late 2024, Capricor filed its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA). However, in July 2025, the FDA responded with a Complete Response Letter (CRL), stating that the BLA did not provide sufficient evidence of effectiveness and required additional clinical data. Capricor asserted that it addressed these issues, leading to heightened investor anticipation as discussions on their product continued.

Unfortunately, the situation took a turn on July 27, 2026, when the FDA released briefing documents before an advisory committee meeting regarding the BLA. Alarmingly, these documents indicated that Capricor had made alterations to a key statistical analysis plan (SAP) just one day before the data was unblinded, prompting the FDA to express serious concerns. The agency found the alterations scientifically unjustified, labeling the analyses derived from these changes as post-hoc and exploratory. This revelation sparked a dramatic decline in Capricor's stock prices, dropping by approximately 64% to close at $7.00 per share.

The following day, the advisory committee convened to review the BLA for Deramiocel. Reports indicated that a non-binding vote resulted in a 9-3 decision where the committee found the evidence insufficient to support the drug's efficacy. This resulted in further declines in stock value for Capricor, which fell to $4.19 per share.

The Role of Pomerantz LLP

Pomerantz LLP, known for its expertise in corporate and securities class litigation, has been at the forefront of advocating for investors' rights. The firm has a storied history dating back to its establishment over 85 years ago, with a commitment to fighting against securities fraud, breaches of fiduciary duty, and corporate misconduct. Their announcement regarding the Capricor lawsuit emphasizes the ongoing support they provide to affected investors, underlining their dedication to pursuing justice and recovery for clients.

For those affected by the situation or interested in joining the class action, it is crucial to stay informed and proactive. The upcoming deadlines present a critical opportunity for investors to assert their rights amidst these troubling developments in the Capricor Therapeutics landscape.