Aardvark Therapeutics Announces FDA Has Lifted the Clinical Hold on ARD-101 for the Treatment of Prader-Willi Syndrome and Will Host Webcast to Review the Available Exploratory Phase 3 HERO/OLE Data

The FDA lifted the clinical hold on Aardvark Therapeutics' lead asset ARD-101 for hyperphagia in Prader-Willi Syndrome, allowing clinical development to resume. The hold stemmed from reversible ECG changes first observed in February 2026; a follow-up ECG study in healthy volunteers at 200 mg and 400 mg twice-daily doses showed no cardiac events. The Phase 3 HERO trial and open-label extension were terminated early and unblinded, and the company will review the available dataset on a webcast October 23 at 8:00 AM ET.

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