The complaint filed by Hagens Berman Sobol Shapiro LLP alleges that Aardvark Therapeutics misled shareholders regarding the safety profile of ARD-101, a small-molecule therapy intended to treat hyperphagia in Prader-Willi Syndrome. According to the filing, the company failed to disclose that clinical trials revealed unexpected cardiac observations, including QRS prolongation, at doses above the target range.
The company’s market valuation faced two major setbacks in 2026. On February 27, Aardvark announced a voluntary pause of its Phase 3 HERO trial due to the cardiac findings, causing the stock to drop more than 56%. The situation worsened on May 14, when the FDA issued a full clinical hold on the company's investigational new drug application, halting ongoing studies and triggering a further 32.1% decline in share price. Reed Kathrein, a partner at Hagens Berman, stated the firm is actively investigating claims that the company overstated the commercial and regulatory prospects of the drug while downplaying its safety risks.




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