Capricor Therapeutics Faces Securities Lawsuit

Capricor Therapeutics, Inc. (NASDAQ: CAPR) is facing a federal securities class action alleging that the company and its leadership made materially false or misleading statements regarding the regulatory prospects of deramiocel, its investigational cell therapy for Duchenne muscular dystrophy. The lawsuit, filed by Glancy Prongay Wolke & Rotter LLP on behalf of investors who purchased Capricor securities between December 17, 2025, and July 26, 2026, centers on allegations that Capricor failed to disclose changes to its pre-specified statistical analysis plan for deramiocel clinical data and that the FDA had not approved these changes before resubmitting its Biologics License Application. These allegations, detailed in the complaint Nkamga v. Capricor Therapeutics, Inc., et al., Case No. 3:26-cv-04385, claim that the undisclosed changes created a significant risk that the FDA could determine the clinical results did not provide substantial evidence of deramiocel’s effectiveness, thereby jeopardizing regulatory approval. The lawsuit follows a sharp decline in Capricor’s stock price after the FDA released briefing materials ahead of a July 29 advisory committee meeting, which raised questions about the sufficiency of the company’s submitted evidence. The FDA advisory panel later concluded that Capricor had not definitively demonstrated that deramiocel benefits patients with heart-related complications from Duchenne muscular dystrophy. The complaint alleges that investors were not adequately informed about these regulatory risks, leading to financial losses. Multiple law firms, including Rosen Law Firm, Hagens Berman Sobol Shapiro LLP, and others, have issued notices or initiated investigations related to the case. The lawsuit remains in its early stages, with no class certified and no findings of liability established. Investors have until September 28, 2026, to seek appointment as lead plaintiff. The case is distinct from an earlier securities class action filed in July 2025, which involved a different class period and allegations. Capricor’s regulatory challenges with deramiocel remain central to its business prospects, and the litigation will examine whether investors received materially accurate information during the alleged class period. The article emphasizes that the allegations are unproven and that the court process will determine any potential liability.

(Source：Stl.news)