Aardvark Therapeutics voluntarily paused dosing and enrollment in its Phase 3 HERO trial of ARD‑101 for hyperphagia in Prader‑Willi syndrome after routine safety monitoring in a healthy volunteer study revealed reversible cardiac observations at supra‑therapeutic doses. The company said the pause is precautionary while it conducts a comprehensive review of the safety data to determine next steps and optimal therapeutic dosing. The halt has squeezed the company’s market value and delayed an expected topline readout. Aardvark emphasized patient safety as its highest priority and will provide an update following the internal review and any additional external safety analyses.
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