Aardvark Therapeutics Shares Plunge 48.7% After FDA Lifts Clinical Hold on ARD-101; PWS Program Targets 2027

Aardvark Therapeutics (AARD) said the FDA lifted the clinical hold on its Investigational New Drug application for ARD-101 on October 22, 2026, clearing the company to plan a new Phase 3 trial in Prader-Willi syndrome. The stock was trading at $2.01, down 48.67%. AARD has ranged between $1.85 and $16.60 over the past year. The company reported exploratory efficacy and safety data from its terminated Phase 3 HERO trial and an open-label extension study. HERO was halted early after 67 of a planned 90 participants were randomized; Aardvark cautioned that all efficacy findings are exploratory and insufficient for definitive conclusions about ARD-101's effectiveness. Data showed a modest reduction in HQ-CT hyperphagia scores versus placebo by week two of dose escalation, with scores returning near baseline after discontinuation. Patients who switched from placebo to ARD-101 in the extension saw an average six-point HQ-CT reduction. One serious cardiac adverse event occurred in a participant on 800 mg twice daily also taking pitolisant; the FDA concurred it was a drug-drug interaction. Aardvark plans to resume dosing below 800 mg twice daily and expects clinical activities to restart in 2027.