India, May 15 -- Aardvark Therapeutics, Inc (AARD) is preparing to unblind data from its Phase 3 HERO trial and its open-label extension after the U.S. FDA placed a full clinical hold on ARD-101, the company's investigational therapy for hyperphagia in Prader-Willi Syndrome. The decision marks a pivotal moment for the program as the company works to determine the most appropriate path forward.
FDA Clinical Hold Prompts Data Review
The FDA's action pauses all studies under the ARD-101 IND, including the HERO Phase 3 trial and the OLE extension. Aardvark stated it is in active discussions with the agency to understand the basis of the hold and identify the steps needed to resume development. The company emphasized that patient safety remain...