Aardvark Therapeutics (AARD) said late Thursday the US Food and Drug Administration placed a full clinical hold on its investigational new drug application for ARD-101 to treat hyperphagia associated with Prader-Willi Syndrome.
The hold applies to all ongoing clinical studies under the IND, the company said, adding that it is in discussions with the FDA for resolution of the clinical hold and to fix a path forward for the drug candidate.
The company also plans to unblind clinical data from the HERO and OLE trials to assess the totality of efficacy and safety data, according to the company.
The company said it had $91.2 million in cash and cash equivalents as of March 31, adequate to fund operations into mid-2027.