Aardvark Therapeutics Faces Class Action Over Alleged Safety Failures

The legal complaint alleges that the biopharmaceutical firm misled shareholders regarding the safety and clinical viability of its lead drug candidate, ARD-101. Designed to treat hyperphagia in Prader-Willi Syndrome patients, the drug allegedly failed to meet the safety standards promised in the company's initial public offering documents. Specifically, the suit claims defendants withheld information about cardiac observations, including QRS prolongation, which surfaced during high-dose trials.

The company’s market valuation eroded rapidly as these risks transitioned from internal findings to public disclosures. In February 2026, a voluntary pause of the Phase 3 HERO trial triggered a 56% decline in share price. By May 14, 2026, the situation intensified when the FDA issued a full clinical hold on the drug’s investigational new drug application, causing an additional 32.1% drop in stock value. Reed Kathrein, a partner at Hagens Berman, stated that the investigation focuses on whether the firm intentionally overstated the drug's clinical and commercial prospects while underplaying critical safety data. Affected investors have until October 13 to petition the court for lead plaintiff status.