The litigation centers on allegations that the San Francisco-based biopharmaceutical firm misled investors regarding the safety of its lead drug candidate, ARD-101. Designed to treat hyperphagia in Prader-Willi Syndrome, the drug faced significant scrutiny after Aardvark disclosed unexpected cardiac issues, specifically QRS prolongation, during clinical trials. The complaint alleges that the company's initial public offering documents and subsequent disclosures failed to adequately warn stakeholders that the drug's safety profile was far more precarious than official statements suggested.
Financial fallout for shareholders followed two major regulatory developments in 2026. On February 27, the company voluntarily paused its Phase 3 HERO trial, triggering a 56% drop in share price. The situation intensified on May 14, when the FDA issued a full clinical hold on the company’s investigational new drug application, halting all studies and sending the stock down an additional 32.1%. Reed Kathrein, a partner at Hagens Berman Sobol Shapiro LLP, stated that the firm is actively investigating claims that the company materially overstated its commercial and regulatory prospects to the market.

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