Investing.com -- Aardvark Therapeutics Inc (NASDAQ:AARD) shares jumped 21% in after-hours trading Thursday after the FDA lifted the clinical hold on the company's ARD-101 drug candidate for the treatment of hyperphagia in Prader-Willi Syndrome.
The clinical hold was placed by the FDA in May 2026 after Aardvark voluntarily paused dosing in its Phase 3 HERO trial and open-label extension trial on February 27, 2026. The pause followed reversible electrocardiogram changes observed during routine safety monitoring in a separate study involving healthy volunteers.
To address the FDA's concerns, Aardvark conducted an ECG study in additional healthy volunteers and an in vitro cardiac sodium channel study. No cardiac events were observed in the recently completed ECG study at ARD-101 doses of 200 mg and 400 mg twice daily.
Aardvark plans to resume clinical development of ARD-101 in patients with Prader-Willi Syndrome following additional engagement with the FDA on the Phase 3 trial design. The company has unblinded data from both the terminated HERO trial and OLE trial to assess available efficacy and safety data.
The company will host a webcast on Friday, October 23, 2026, at 8:00 a.m. EST to review the dataset from the terminated trials.
ARD-101 is an oral, small-molecule therapeutic designed to stimulate the release of gut-peptide hormones through activation of bitter taste receptors. The drug is being developed as a treatment for hyperphagia associated with Prader-Willi Syndrome, a rare genetic disorder characterized by insatiable hunger.
Original Article
Aardvark Therapeutics stock surges as FDA lifts clinical hold
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