Aardvark Therapeutics Faces Class Action Over ARD-101 Safety Disclosures

The complaint centers on the company’s clinical-stage efforts to treat hyperphagia in Prader-Willi Syndrome. Plaintiffs allege that Aardvark failed to disclose significant safety concerns, specifically reversible cardiac observations like QRS prolongation detected during trials at above-target doses. These omissions reportedly led to an overstatement of the company’s commercial and regulatory prospects, including its Phase 3 HERO trial.

Market confidence eroded in early 2026 as these safety issues surfaced. On February 27, Aardvark voluntarily paused its Phase 3 trial, triggering a 56% drop in share price. The situation deteriorated further on May 14, when the FDA placed a full clinical hold on the company’s investigational new drug application for ARD-101. That announcement resulted in an additional 32.1% decline in stock value. Reed Kathrein, a partner at Hagens Berman, stated the firm is investigating whether Aardvark misled shareholders about the drug’s development and efficacy throughout the class period.

Investors wishing to serve as lead plaintiff in the pending litigation must file their motions with the court no later than October 13, 2026. The firm is also inviting whistleblowers with non-public information regarding the company's clinical trials or regulatory disclosures to come forward.