The complaint alleges that Aardvark Therapeutics failed to disclose significant safety issues associated with ARD-101, a treatment intended for hyperphagia in Prader-Willi Syndrome. According to the suit, the company’s offering documents and subsequent public statements overstated the drug's clinical and commercial prospects while omitting reports of reversible cardiac observations, including QRS prolongation, detected during trials at above-target doses.
Financial fallout for shareholders followed a series of regulatory disclosures. On February 27, 2026, Aardvark announced a voluntary pause of its Phase 3 HERO trial, triggering a stock price decline of over 56%. The situation deteriorated further on May 14, 2026, when the FDA placed a full clinical hold on the company’s investigational new drug application for ARD-101, halting all ongoing studies and causing an additional 32.1% drop in share value. Reed Kathrein, a partner at Hagens Berman, stated that the firm is investigating claims that Aardvark misled investors about the development, safety, and efficacy of the drug throughout the relevant period.


Comments (0)
No comments yet. Be the first!