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

• FDA lifted the full clinical hold on Aardvark Therapeutics' ARD-101 for Prader-Willi syndrome on October 22, 2026.
• The company plans to seek FDA agreement on a new Phase 3 trial designed to support a future marketing application.
• PWS clinical activities are expected to resume in 2027, with dosing below 800 mg twice daily pending FDA discussions.
• FDA linked a cardiac serious adverse event at 800 mg twice daily to a drug interaction in a participant taking pitolisant.

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: 202610230700PRIMZONEFULLFEED9851845) on October 23, 2026, and is solely responsible for the information contained therein.