The investigation centers on the company’s previous assurances that ARD-101 possessed a tolerable safety profile. Before the market rout, Aardvark had repeatedly touted the drug as a first-in-class treatment for hyperphagia in patients with Prader-Willi Syndrome. The company had publicly claimed alignment with the FDA while expanding trial cohorts to include children as young as four.

Confidence evaporated when the company abruptly paused the HERO trial, citing "reversible cardiac observations." This disclosure forced the company to walk back its previous timeline, confirming that topline data would not be available in the third quarter of 2026 as once anticipated. Reed Kathrein, the partner leading the Hagens Berman investigation, stated the firm is now scrutinizing the accuracy of the company’s disclosures concerning development data and its regulatory interactions. Analysts have since slashed price targets, while the firm is seeking contact from investors and potential whistleblowers to determine if federal securities laws were violated.