Aardvark Therapeutics’ Phase 3 program for its Prader-Willi syndrome metabolic drug ARD-101 was placed on full FDA clinical hold, halting ongoing testing. The hold follows cardiovascular concerns detected in a higher-dose safety study in healthy volunteers, prompting Aardvark to pause dosing earlier this year. Aardvark said it will “unblind” the Phase 3 study so investigators and regulators can determine whether the drug showed early efficacy and reconcile safety signals with the dose levels used in the trial. The company reported dosing 68 patients on placebo-controlled Phase 3 and 19 patients in an open-label extension. With roughly $90 million in cash, the company faces funding pressure on a timetable that could run into 2027, depending on what path forward the FDA accepts for dose adjustments and trial redesign. The company’s program comes after Soleno Therapeutics’ Vyktat became the only approved therapy for Prader-Willi hyperphagia.