#USA #California #Securities Fraud #deramiocel #Capricor Therapeutics

Capricor Therapeutics Faces Securities Fraud Allegations Amid Major Stock Drop

In a significant financial upheaval, Capricor Therapeutics, Inc. (NASDAQ: CAPR) is contending with a class action lawsuit following a steep 64% decline in its stock value. The lawsuit, announced by prominent securities law firm Bleichmar Fonti & Auld LLP, alleges that the company and certain executives made false statements regarding their lead product candidate, Deramiocel, and the integrity of the clinical data backing its Biologics License Application (BLA).

Background of the Lawsuit

Capricor Therapeutics has built a reputation as a biotechnology firm focused on developing novel cell and exosome-based therapeutics aimed at treating rare diseases. The centerpiece of its development efforts, Deramiocel, has been touted as a groundbreaking investigational cell therapy targeting Duchenne muscular dystrophy (DMD). However, issues surrounding its approval and associated data have ignited significant controversy.

According to the legal complaint filed in the U.S. District Court for the Southern District of California, Capricor is accused of having submitted misleading information regarding Deramiocel’s effectiveness. In late 2024, the company submitted their BLA to the FDA, which subsequently issued a Complete Response Letter in July 2025, highlighting shortcomings in the evidence supporting the therapy's effectiveness and calling for additional clinical data.

The lawsuit suggests that Capricor failed to disclose critical changes made to the pre-specified statistical analysis plan used in evaluating their clinical data for Deramiocel. These changes, it is alleged, were not sanctioned by the FDA prior to the resubmission of the BLA.

Capricor's Stock Plunge Explained

The situation escalated dramatically on July 27, 2026, when the FDA released briefing documents ahead of an advisory committee meeting. The documents raised concerns surrounding the post-hoc adjustments made to Capricor's statistical methods, including alterations to the primary endpoint calculation. Investors reacted strongly, with CAPR stock plummeting from a closing price of $19.70 per share to just $7.00, marking a staggering decrease of 64.5%.

Further complicating matters, on July 29, the FDA advisory committee convened to deliberate on the Deramiocel BLA. The next day, a medical report from Medscape revealed that the committee had cast a non-binding vote of 9-3, indicating insufficient evidence to substantiate the efficacy of Deramiocel for treating DMD-associated cardiomyopathy. This unfavorable outcome sent Capricor's shares tumbling again, dropping 36% to a mere $4.19 per share by July 30, 2026.

Investor Actions and Timeline

Investors who believe they have been adversely affected by Capricor's stock drop are urged to take legal action before the deadline of September 28, 2026, to have their voices heard in court. The legal claim points to securities fraud violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.

Bleichmar Fonti & Auld LLP, recognized for its successful track record in class action lawsuits, emphasizes that all representation comes on a contingency fee basis, meaning that investors will incur no legal costs unless a recovery is achieved.

Conclusion

As Capricor Therapeutics faces intense scrutiny and potential legal ramifications, the trajectory of the company's future hangs in the balance. For current and potential investors, understanding the implications of this lawsuit and the underlying issues concerning Deramiocel will be vital as events unfold. The case is currently titled Nkamga v. Capricor Therapeutics, Inc. et al., No. 26-cv-04385, in the U.S. District Court for the Southern District of California.