FDA lifts Aardvark's ARD-101 hold as further trial planning continues
Aardvark Therapeutics ($AARD) said the FDA lifted the clinical hold on ARD-101, its investigational treatment for excessive hunger associated with Prader-Willi syndrome. The hold followed a voluntary dosing pause after reversible electrocardiogram changes were observed in a separate healthy-volunteer study. The company subsequently supplied additional cardiac-safety evidence. That work included a healthy-volunteer study at 200- and 400-milligram twice-daily doses and laboratory testing of a card
0