Aardvark Therapeutics disclosed it is moving to unblind data from its Phase 3 Prader-Willi syndrome program after the FDA imposed a full clinical hold. The hold follows a cardiac safety signal seen earlier in healthy volunteers, which Aardvark initially paused voluntarily and then expanded across ARD-101 and related studies. Aardvark said it expects unblinding to support an “informed determination of next steps” for ARD-101 and the associated open-label extension. The company reported it had dosed 68 patients in the randomized Phase 3 study and 19 patients in the extension when dosing paused. The decision compresses timelines for data readouts and partnering or fundraising actions, making the next FDA interaction central to preserving the company’s options.