Aardvark Therapeutics Faces Investor Lawsuit Over Drug Safety Disclosures

The shareholder rights firm Hagens Berman is currently investigating whether Aardvark misled investors regarding the development and efficacy of ARD-101. The company, which previously marketed the drug as a first-in-class treatment for Prader-Willi Syndrome, had maintained that its clinical trials were aligned with FDA expectations and possessed a highly tolerable safety record. These claims are now under scrutiny following a series of regulatory setbacks and failed trial milestones.

Investors suffered a major blow on March 2, 2026, when the firm halted its Phase 3 HERO trial, citing reversible cardiac observations in patients. That announcement alone triggered a 56 percent drop in share price. By mid-May, after the FDA formalized a full clinical hold on all ongoing studies under the company’s investigational new drug application, the stock had shed 63 percent of its value compared to late February. Partner Reed Kathrein, who is leading the investigation, stated the firm is now auditing the company’s internal communications with regulators to determine if the public was intentionally kept in the dark about the true risks of the drug development process.