The complaint alleges that Aardvark Therapeutics failed to disclose significant safety risks associated with ARD-101, a drug intended to treat hyperphagia in Prader-Willi Syndrome. According to the filing, the company's internal data revealed reversible cardiac observations, specifically QRS prolongation, during trials at doses exceeding therapeutic targets. These findings contradict the company's prior public statements regarding the drug's clinical prospects and the viability of its Phase 3 HERO trial.
Aardvark Therapeutics Faces Securities Class Action Over Drug Safety
Investors in Aardvark Therapeutics have until October 13, 2026, to file for lead plaintiff status in a securities class action lawsuit. The litigation centers on allegations that the clinical-stage biopharmaceutical firm misrepresented the safety profile of its lead candidate, ARD-101, during and after its February 2025 initial public offering.
Market confidence eroded in early 2026 as the truth surfaced. On February 27, Aardvark announced a voluntary pause of its Phase 3 HERO trial, triggering a stock price collapse of more than 56%. The situation deteriorated further on May 14, when the FDA imposed a full clinical hold on the company’s investigational new drug application. This regulatory intervention caused an additional 32.1% decline in share value. Hagens Berman partner Reed Kathrein stated that the firm is investigating whether the company misled shareholders regarding the development, safety, and efficacy of its primary asset.
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