Aardvark Therapeutics Faces Class Action Lawsuit Over Drug Safety Claims

The litigation centers on claims that Aardvark Therapeutics, a firm developing treatments for Prader-Willi Syndrome, failed to disclose significant safety issues during its clinical trials. According to the complaint, the company’s public filings omitted key data regarding unexpected cardiac observations, specifically QRS prolongation, which emerged during tests at doses exceeding the target therapeutic range. These omissions allegedly led to an overstatement of the company’s commercial and regulatory prospects, including the Phase 3 HERO trial.

The market reality began to surface on February 27, 2026, when Aardvark voluntarily paused its HERO study, triggering a 56% decline in share price. The situation intensified on May 14, 2026, when the FDA issued a full clinical hold on the company’s investigational new drug application for ARD-101, halting all active studies and causing the stock to drop an additional 32.1%. Reed Kathrein, the Hagens Berman partner heading the investigation, contends that the company misled stakeholders about the development, safety, and efficacy of their primary pipeline asset.

Investors wishing to serve as a Lead Plaintiff in this action 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 internal practices to come forward, citing potential eligibility for SEC reward programs.