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.
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Aardvark Therapeutics Cleared to Resume Prader-Willi Trials
Following a seven-month suspension, the Food and Drug Administration has lifted the clinical hold on ARD-101, an experimental treatment for hyperphagia in Prader-Willi Syndrome. Aardvark Therapeutics confirmed the regulatory green light yesterday, noting that the company has satisfied all agency requirements to move forward with its testing program.
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