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FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi syndrome
AARDAardvark Therapeutics, Inc.
The FDA lifted the full clinical hold on Aardvark Therapeutics' investigational drug ARD-101, allowing the company to resume clinical development for hyperphagia in patients with Prader-Willi syndrome. The regulatory clearance follows a review of exploratory efficacy and safety data from the terminated Phase 3 HERO trial and its open-label extension. Aardvark plans to request an FDA meeting to align on the design of a new Phase 3 program, with clinical activities expected to resume in 2027. The company operates as a clinical-stage biopharmaceutical firm developing small-molecule therapeutics for hunger suppression.