Aardvark Therapeutics: FDA lifts clinical hold on ARD-101 IND

What happened On Oct 22, 2026, Aardvark Therapeutics, Inc. issued a press release announcing that the U.S. Food and Drug Administration lifted the clinical hold on the Company’s Investigational New Drug application for ARD-101 for the treatment of hyperphagia in Prader-Willi Syndrome. The press release is filed as Exhibit 99.1 to this Current Report on Form 8-K. The company also announced it will host a live conference call for investors on Oct 23, 2026 at 8:00 a.m. ET.

Key details

• FDA lifted the clinical hold on the ARD-101 IND for treatment of hyperphagia in Prader-Willi Syndrome.
• Press release dated Oct 22, 2026 is filed as Exhibit 99.1 to the Form 8-K.
• Live conference call scheduled for Oct 23, 2026 at 8:00 a.m. ET.
• Reported under Item 8.01 (Other events); exhibits reported under Item 9.01.

Why it may matter The filing reports an Item 8.01 other event, which covers company announcements and developments the company chose to disclose, and includes the press release as an exhibit under Item 9.01. A filing does not show why the insider traded or why the company acted.