Aardvark Therapeutics said it is voluntarily pausing enrollment and dosing in its Phase 3 HERO trial evaluating ARD-101 for hyperphagia in patients with Prader-Willi syndrome, along with the related open-label extension study. The pause follows reversible cardiac observations at above-target therapeutic doses identified during routine safety monitoring in a healthy volunteer study, and the company is conducting a comprehensive data review while continuing discussions with the FDA and experts. Aardvark said it no longer expects to report HERO topline data in the third quarter of 2026 and plans to provide further guidance in the second quarter of 2026; no trial efficacy results were reported in the announcement.
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: 202602271605PRIMZONEFULLFEED9663148) on February 27, 2026, and is solely responsible for the information contained therein.