FDA places full clinical hold on Aardvark's drug for extreme hunger in Prader-Willi syndrome
14/05/2026 21:51
May 14 (Reuters) - Aardvark Therapeutics AARD.O on Thursday said the U.S. Food and Drug Administration placed a full clinical hold on its drug to treat extreme hunger linked to the rare disorder Prader-Willi syndrome, halting all late-stage trials. Shares of the company fell about 14% in after-hours trading. Aardvark had paused enrollment and dosing in February after it found heart-related side effects in healthy volunteers given higher-than-planned doses of the drug, ARD-101. The FDA's clinical hold applies to all studies on ARD-101, including a late-stage trial and extension study in Prader-Willi syndrome. The hold follows a previously announced voluntary pause, the company said, adding that it is in active discussions with the regulator to resolve the issue. The drug developer said that 68 patients were dosed in the main study and 19 in the extension as of late February. It added that it would review study data to assess safety and efficacy and determine next steps. Aardvark's ARD-101, being developed as an oral medication, works by triggering gut hormones through activation of taste receptors. The company said it had $91.2 million in cash and investments as of March-end, which it expects will fund operations into mid-2027. (Reporting by Sahil Pandey in Bengaluru; Editing by Diti Pujara) ((Sahil.Pandey@thomsonreuters.com;))