The FDA placed Aardvark Therapeutics’ ARD-101 drug for Prader-Willi syndrome under a clinical hold, pausing the company’s trials after a cardiovascular concern emerged in a safety study in healthy volunteers. Aardvark said it will unblind participants so regulators and investigators can interpret the safety context and determine next steps for efficacy and dosing. According to the company, it has dosed 68 people in the placebo-controlled Phase 3 trial and another 19 in an open-label extension study. The cardiovascular findings emerged with higher doses than used in those studies, leaving uncertainty over what dosing regimen the FDA will accept. Aardvark is also managing cash runway risk as the company’s reserves are expected to run out by mid-2027 absent new financing or revised trial plans. The hold increases pressure to agree quickly with the FDA on a path forward to sustain development toward a potential approval. ARD-101 is designed to stimulate secretion of GLP-1 and cholecystokinin to improve satiety in a disorder driven by hypothalamic hormone deficiencies that cause hyperphagia. The FDA action is a direct inflection point for the program’s timeline and investor sentiment.