The complaint centers on claims that Aardvark failed to disclose significant safety risks associated with ARD-101, a small-molecule therapy intended to treat hyperphagia in Prader-Willi Syndrome. According to the suit, the company’s clinical and commercial prospects were inflated, ignoring evidence of reversible cardiac observations, such as QRS prolongation, detected during trials.
These issues reached a breaking point in early 2026. On February 27, Aardvark voluntarily paused its Phase 3 HERO trial, triggering a 56% drop in share price. The situation worsened on May 14 when the FDA placed a full clinical hold on the company’s investigational new drug application, halting all studies and causing a further 32.1% decline in stock value. Reed Kathrein, a partner at Hagens Berman, stated that the firm is actively investigating allegations that the company misled investors about the drug's development and efficacy. Shareholders wishing to serve as lead plaintiff must file their motion by October 13, 2026.



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