The FDA placed a full clinical hold on Aardvark Therapeutics’ Prader-Willi syndrome drug program, stopping all tests of the company’s small-molecule candidate ARD-101 after a cardiovascular safety signal emerged in a prior high-dose healthy-volunteer study. Aardvark previously paused trials voluntarily and then expanded the pause to additional related studies. Under the clinical hold, the company said it will unblind trial data to support regulators’ assessment of safety and efficacy. The company reported it had dosed 68 people in the Phase 3 trial and 19 in an open-label extension before the stop. Aardvark is targeting hyperphagia in PWS via stimulation of GLP-1 and cholecystokinin secretion, positioning ARD-101 as a potential oral alternative in a difficult-to-treat rare condition. With cash reserves described as limiting runway, the hold pressures the company to negotiate a path forward with FDA or pursue new funding or partnering before time runs out. The market impact was immediate in the reporting, with Aardvark shares falling sharply on the hold news.