Aardvark Therapeutics Faces Securities Fraud Lawsuit Over Drug Safety

The litigation centers on claims that Aardvark’s IPO documents and subsequent public statements obscured significant safety risks associated with ARD-101. Specifically, the lawsuit contends the company failed to disclose that trials at doses above the target range resulted in cardiac observations, including QRS prolongation. These omissions reportedly led to an overstatement of the drug’s clinical and commercial viability.

Market confidence eroded in early 2026 as these safety concerns surfaced. On February 27, Aardvark announced a voluntary pause of its Phase 3 HERO trial, citing cardiac findings in a healthy volunteer study; the stock price subsequently dropped more than 56%. The situation deteriorated further on May 14, when the FDA imposed a full clinical hold on the company's investigational new drug application. This move halted all ongoing studies, including the HERO and open-label extension trials, triggering an additional 32.1% decline in share value.

Hagens Berman Sobol Shapiro LLP, the firm leading the class action, is currently investigating the extent of the alleged misrepresentations. Reed Kathrein, a partner at the firm, stated that the inquiry focuses on whether Aardvark misled investors regarding the development and efficacy of its therapy. Shareholders seeking to serve as lead plaintiff in the action must file their motions with the court by October 13, 2026.