FDA placed Aardvark Therapeutics’ Prader-Willi syndrome program under a full clinical hold, halting further testing of ARD-101 and related studies following a cardiovascular safety issue observed in a healthy volunteer. Aardvark had earlier paused parts of its program voluntarily after the signal, then expanded the pause across ARD-101 and an ARD-201 combination approach. With the formal hold now in place, the company said it will unblind trial data to support regulator review of safety and efficacy. The company reported it had dosed 68 patients in the randomized Phase 3 trial and 19 in an open-label extension. The hold also adds financing pressure as cash runway is projected to reach mid-2027, tightening timelines for any resumption path agreed with FDA.