The complaint alleges that Aardvark Therapeutics failed to disclose significant safety concerns surrounding ARD-101, a treatment targeting bitter taste receptors for Prader-Willi Syndrome. According to the suit, the company’s offering documents and public statements overstated the drug's safety profile, specifically omitting that clinical trials had revealed reversible cardiac observations, such as QRS prolongation, at doses exceeding the target range. These omissions allegedly inflated the perceived commercial and regulatory potential of the firm's Phase 3 HERO trial and related studies.
The market began to react on February 27, 2026, when Aardvark announced a voluntary pause on its HERO trial following safety monitoring results. Shares plummeted more than 56% on the news. The situation worsened on May 14, 2026, when the FDA issued a full clinical hold on the company’s investigational new drug application, halting all studies and triggering a further 32.1% decline in stock value.



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