Aardvark Therapeutics Faces Class Action Lawsuit Over Safety Disclosures

The complaint alleges that between February 13, 2025, and May 14, 2026, Aardvark Therapeutics failed to adequately disclose safety risks associated with its small-molecule therapy, ARD-101, which is intended to treat hyperphagia in Prader-Willi Syndrome. According to the suit, the company purportedly overstated the commercial and clinical prospects of the drug, despite observing reversible cardiac issues, such as QRS prolongation, during trials at doses above the therapeutic target.

The market impact became apparent on February 27, 2026, when the company voluntarily paused its Phase 3 HERO trial, triggering a 56% drop in stock price. The situation deteriorated further on May 14, 2026, when the U.S. Food and Drug Administration imposed a full clinical hold on the company's investigational new drug application. That announcement prompted an additional 32.1% decline in AARD shares. Reed Kathrein, a partner at Hagens Berman Sobol Shapiro LLP, stated that the firm is investigating allegations that the company misled stakeholders regarding the drug's development and efficacy. Investors seeking to participate as lead plaintiff have until October 13, 2026, to file with the court.