FDA places full clinical hold on Aardvark's ARD-101 IND; HERO and OLE trials paused

Aardvark Therapeutics, Inc.

FDA full clinical hold on IND for ARD-101, affecting Phase 3 HERO trial (AVK-101-301) and OLE trial (AVK-101-302).
Company to unblind accumulated data from 68 HERO patients and 19 OLE patients to inform next steps.
Cash of $91.2M as of March 31, 2026, expected to fund operations into mid-2027.
Active discussions with FDA ongoing to resolve clinical hold and determine path forward.

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