The FDA placed a full clinical hold on Aardvark Therapeutics’ ARD-101 and related studies for Prader-Willi syndrome after a cardiovascular safety signal emerged in a higher-dose healthy volunteer study. Aardvark said it will unblind ongoing Phase 3 data to support discussions on next steps for the program. Aardvark had previously paused its trials voluntarily in March and later expanded the pause to ARD-201, combining ARD-101 with a DPP-4 inhibitor. In the Phase 3 trial, the company had dosed 68 people in the placebo-controlled study and 19 in an open-label extension. Analysts said unblinding could potentially clarify efficacy signals, but the dosing constraints implied by the cardiovascular issues leave uncertainty around what the FDA will accept. The clinical hold also tightens the company’s financing timeline as cash runway shortens into mid-2027 absent a path forward.