Aardvark Therapeutics announces FDA clinical hold on ARD-101

Aardvark Therapeutics (AARD) announced that the U.S. Food and Drug Administration has placed a full clinical hold on its investigational new drug application for ARD-101, related to the company’s previously announced voluntary pause. The clinical hold applies to all ongoing clinical studies, including the Phase 3 HERO trial evaluating ARD-101 for the treatment of hyperphagia in patients with Prader-Willi Syndrome. In parallel with its ongoing engagement with the FDA, Aardvark intends to unblind the accumulated clinical data across its trials to assess efficacy and safety and determine a path forward. As of March 31, the company held $91.2M in cash, cash equivalents and short-term investments, which it expects to fund operations into mid-2027.