FDA Lifts Clinical Hold on Aardvark's ARD-101, Clearing San Diego Biotech to Resume Prader-Willi Trial Work
San Diego: Aardvark Therapeutics, Inc. (Nasdaq: AARD), a clinical-stage biopharmaceutical company based in San Diego, announced on October 22 that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Investigational New Drug application for its candidate ARD-101, being developed to treat hyperphagia in people with Prader-Willi Syndrome (PWS). Clinical development of ARD-101 may now resume.
The hold traced back to a safety monitoring finding earlier this year. On February 27, 2026, Aardvark voluntarily paused dosing in its Phase 3 HERO trial and its open-label extension trial after reversible electrocardiogram (ECG) changes were observed during routine safety monitoring in a separate study in healthy volunteers. In May 2026, the FDA placed a formal clinical hold on both trials. Working in alignment with the FDA, the company then completed a thorough ECG study in additional healthy volunteers and an in vitro cardiac sodium channel (NaV1.5) study; it said no cardiac events were observed in the recently completed ECG study at doses of 200 mg and 400 mg twice daily.
Tien Lee, M.D., Aardvark's founder and chief executive officer, said the company was pleased the FDA lifted the hold, allowing it to continue advancing the program, and noted that people living with PWS and their families continue to face profound unmet need. The company said it plans to resume clinical development of ARD-101 in patients with PWS following further engagement and alignment with the FDA on the Phase 3 trial design. Aardvark has unblinded data accumulated across the terminated HERO and open-label extension trials and will host a webcast on October 23 at 8:00 a.m. Eastern Time to review the available dataset.
Prader-Willi Syndrome is a rare genetic disorder characterized in part by insatiable hunger. ARD-101 is an oral, small-molecule therapeutic designed to stimulate the release of gut-peptide hormones through activation of bitter taste receptors. According to Dow Jones Newswires, Aardvark shares rose 14% to $4.52 in after-hours trading following the announcement.
Published by GSM · USA (original Chinese edition)
Photo: 图：生物技术实验室内的研究人员（资料图）。Idaho National Laboratory 摄，CC BY 2.0，经维基共享资源。Photo: Researchers in a biotechnology laboratory (file photo). Photo by Idaho National Laboratory, CC BY 2.0, via Wikimedia Commons.
