FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
Aardvark Therapeutics is a clinical-stage biopharmaceutical company developing small-molecule therapeutics that activate innate homeostatic pathways — including bitter taste receptors (TAS2R) — to treat metabolic and inflammatory disease. Its lead candidate ARD-101 targets hyperphagia in Prader-Willi syndrome; the Phase 3 HERO trial was voluntarily paused in February 2026 and terminated, and the FDA lifted its clinical hold in October 2026, leaving the programme awaiting a redesigned Phase 3 and a lower-dose resumption. A second programme, ARD-201, is in development for obesity.
FDA meeting on a new Phase 3 design and lower-dose ARD-101 resumption; PWS clinical activity expected to restart
FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns
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