Capricor Therapeutics Faces Securities Fraud Suit Over Stock Drop
News related to:Capricor Therapeutics, Inc · 2 min read
Capricor Therapeutics, Inc., a biotechnology company focused on developing cell and exosome-based therapeutics for rare diseases, faces a significant legal challenge following a major stock drop. The company has been sued for securities fraud, alleging that it made false statements regarding its lead product, Deramiocel, and the integrity of the clinical data supporting its Biologics License Application (BLA). This lawsuit comes as the company's stock price plummeted by 64.5% on July 27, 2026, following the release of FDA briefing documents that raised concerns about the statistical analysis of the clinical data.
The lawsuit was filed by the law firm Bleichmar Fonti & Auld LLP on behalf of investors who purchased Capricor Therapeutics securities. According to the complaint, Capricor failed to disclose that it had made changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel without the FDA's approval. This omission, the complaint alleges, constitutes a violation of the federal securities laws.
The FDA had issued a Complete Response Letter in late 2024, stating that Capricor's BLA for Deramiocel did not meet the statutory requirement for substantial evidence of effectiveness and needed additional clinical data. On July 27, 2026, the FDA released briefing documents ahead of an advisory committee meeting, which highlighted concerns about the post-hoc changes to the statistical analysis plan. This news caused a significant drop in the company's stock price, with the price falling from $19.70 per share to $7.00 per share, a 64.5% decline, the following trading day.
The advisory committee met the next day, and a non-binding 9-3 vote concluded that the available evidence did not support the efficacy of Deramiocel for treating Duchenne muscular dystrophy-associated cardiomyopathy. This news further contributed to the stock's decline, with the price dropping an additional $2.38 per share, or 36%, to $4.19 per share by the end of trading on July 30, 2026.
The lawsuit alleges that Capricor's failure to disclose these changes and the FDA's concerns violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. Investors are encouraged to obtain additional information by visiting the firm's website: www.bfalaw.com/cases/capricor-class-action-lawsuit.
Lead plaintiffs must act by September 28, 2026, to be considered for appointment to lead the case. The complaint is pending in the U.S. District Court for the Southern District of California, and the case is titled Nkamga v. Capricor Therapeutics, Inc. et al., No. 26-cv-04385.
If you invested in Capricor Therapeutics securities, you may have legal options and are encouraged to submit your information to the firm. All representation is on a contingency fee basis, and there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.
BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It has been named a top plaintiff law firm by Chambers USA, The Legal 500, and ISS SCAS, and its attorneys have been recognized for their expertise and dedication to client service.