Aardvark Therapeutics stock surges as FDA lifts clinical hold

What happened: The FDA lifted the clinical hold on Aardvark Therapeutics' ARD-101 drug candidate for hyperphagia in Prader-Willi Syndrome. Shares jumped 21% in after-hours trading Thursday. Key numbers: 21% after-hours gain. Hold placed May 2026. Dosing paused February 27, 2026. ECG study tested 200 mg and 400 mg twice daily. Why it matters: Aardvark plans to resume clinical development of ARD-101 after further engagement with the FDA on Phase 3 trial design. The company has unblinded data from the terminated HERO and OLE trials to assess efficacy and safety.

The FDA lifted the clinical hold on Aardvark Therapeutics' ARD-101 drug candidate for hyperphagia in Prader-Willi Syndrome. Shares jumped 21% in after-hours trading Thursday.

Aardvark plans to resume clinical development of ARD-101 after further engagement with the FDA on Phase 3 trial design. The company has unblinded data from the terminated HERO and OLE trials to assess efficacy and safety.