Aardvark Therapeutics Cleared to Resume Prader-Willi Trials

The regulatory pause began in May, though the company had already moved to stop dosing in its Phase 3 and open-label extension trials back in February. That earlier decision followed the observation of reversible electrocardiogram changes during a separate safety study conducted on healthy volunteers. By addressing these cardiac signals through collaborative review with the FDA, the company believes it has cleared the path for the resumption of clinical development. Aardvark shares were temporarily halted in anticipation of the announcement.