FDA removes clinical hold on Aardvark's ARD-101 after reversible ECG changes paused dosing

The FDA removed the clinical hold on Aardvark Therapeutics' ARD-101 for hyperphagia in Prader-Willi syndrome. The hold, implemented in May 2026, followed reversible electrocardiogram changes in a healthy-volunteer study that had paused dosing in the Phase 3 HERO and open-label extension trials. The company targets a new Phase 3 trial.

Detected & updated continuously · Source: Nebula