FDA lifts clinical hold on Aardvark Therapeutics’ ARD-101 for Prader-Willi syndrome

• FDA lifted the clinical hold on Aardvark Therapeutics’ ARD-101 for hyperphagia in Prader-Willi syndrome, allowing clinical development to resume.
• Resumption of patient trials remains subject to further FDA engagement on Phase 3 trial design.
• The FDA imposed the hold in May 2026 following reversible ECG changes in healthy volunteers.
• A subsequent healthy-volunteer ECG study found no cardiac events at ARD-101 doses of 200 mg and 400 mg twice daily.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Aardvark Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610221605PRIMZONEFULLFEED9851574) on October 22, 2026, and is solely responsible for the information contained therein.