FDA lifts clinical hold on Aardvark's ARD-101 for Prader-Willi syndrome hyperphagia

Aardvark Therapeutics, Inc.

• Clinical hold lifted Oct. 22, 2026; Aardvark says development of ARD-101 in PWS hyperphagia may resume.
• Hold followed Feb. 27, 2026 voluntary dosing pause in Phase 3 HERO and OLE trials after reversible ECG changes seen in a separate healthy-volunteer study; FDA imposed hold in May 2026.
• New ECG study at 200 mg and 400 mg twice daily showed no cardiac events; in vitro NaV1.5 cardiac sodium channel study also completed with FDA alignment.
• Aardvark unblinded data from the terminated HERO and OLE trials; will review the available exploratory dataset on a webcast Oct. 23, 2026 at 8:00 a.m. ET.
• Resumption timing depends on further FDA engagement on Phase 3 trial design; CEO Tien Lee cited 'profound unmet need' in PWS.