Aardvark Therapeutics said the FDA imposed a full clinical hold on its Prader-Willi syndrome program, pausing trials across ARD-101 and related studies following a cardiac safety signal in healthy volunteers. The company had previously paused work voluntarily after QRS prolongation thresholds were observed at the phase 3 dose without titration, and later expanded the pause to ARD-201. With the hold now in place, Aardvark plans to unblind data from its phase 3 ARD-101 study and associated open-label extension. The company said the move is intended to assess the “totality of available efficacy and safety data” to support next-step decisions and preserve options for a financing or partnership window.