Aardvark Therapeutics Faces Class Action Over Alleged Safety Failures

The complaint centers on disclosures surrounding ARD-101, a small-molecule therapy intended to treat hyperphagia in Prader-Willi Syndrome. According to the filing, Aardvark failed to reveal that the drug posed significant safety risks, specifically citing reversible cardiac observations such as QRS prolongation noted in subjects receiving above-target doses. The lawsuit contends these omissions led to an inflation of the company's clinical and commercial potential.

The firm's market value suffered two sharp declines following safety revelations. On February 27, 2026, Aardvark shares plummeted more than 56% after the company voluntarily paused its Phase 3 HERO trial. The situation worsened on May 14, 2026, when the U.S. Food and Drug Administration issued a full clinical hold on the company’s investigational new drug application. The stock dropped an additional 32.1% following the regulatory intervention.

Reed Kathrein, the Hagens Berman partner overseeing the investigation, stated the firm is examining claims that the company misrepresented the development, safety, and efficacy of its primary product. Investors seeking to serve as Lead Plaintiff in the litigation have until October 13, 2026, to file their motions with the court.