Aardvark Therapeutics’ Prader-Willi syndrome program hit a major regulatory setback as the FDA placed a full clinical hold on ARD-101 and related studies. The hold follows a cardiovascular safety signal observed in a healthy-volunteer study at higher doses, prompting Aardvark to pause trials earlier this year and then expand the pause to additional candidates. In response, Aardvark said it will unblind data from its Phase 3 trial and open-label extension to support regulator and investigator review of the totality of efficacy and safety data. The company has already dosed 68 patients in the placebo-controlled Phase 3 study and 19 in the open-label extension, and it faces potential financing pressure as its cash runway tightens into mid-2027.