Aardvark Therapeutics Faces Class Action Over Safety Disclosure Failures

The complaint alleges that the biopharmaceutical company concealed critical safety concerns involving ARD-101, a small-molecule therapy intended to treat hyperphagia in Prader-Willi Syndrome. According to the filing, the company failed to disclose that the drug exhibited reversible cardiac issues, such as QRS prolongation, during trials at doses exceeding target therapeutic levels. These omissions reportedly led to an overstatement of the company's clinical and regulatory prospects, including its Phase 3 HERO trial.

The market reacted sharply as the truth surfaced. On February 27, 2026, the company announced a voluntary pause of its Phase 3 trials, triggering a 56% drop in share 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. This regulatory intervention caused an additional 32.1% decline in the stock value.

Reed Kathrein, a partner at Hagens Berman Sobol Shapiro LLP, stated that the firm is investigating whether Aardvark misled investors regarding the development, safety, and efficacy of its pipeline. Affected shareholders have until October 13, 2026, to petition the court for appointment as lead plaintiff in the pending litigation.