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 remains its highest priority as it evaluates next steps.
Understanding ARD-101's Approach
ARD-101 is an oral small-molecule therapeutic designed to activate bitter taste receptors in the gut, triggering the release of hormones that help regulate hunger. The approach aims to address hyperphagia, one of the most challenging and dangerous symptoms of PWS, which can lead to severe obesity and life-threatening complications. As of February 27, 2026, 68 patients had been dosed in the randomized HERO study and 19 in the OLE trial.
Company to Unblind HERO and OLE Data
To support its regulatory engagement, Aardvark plans to unblind all accumulated data from both studies. The company believes that reviewing the full dataset will help clarify the safety and efficacy profile of ARD-101 and guide discussions with the FDA on the future of the program. CEO Tien Lee, MD, reaffirmed the company's commitment to the PWS community and noted that the unblinded data will be central to determining the next steps.
Financial Position and Runway
Aardvark ended the first quarter of 2026 with $91.2 million in cash, cash equivalents, and short-term investments. The company expects this balance to fund operations into mid-2027 as it works through the regulatory process and evaluates the broader potential of ARD-101 across hunger-related metabolic conditions.
AARD has traded between $3.35 and $17.94 over the past year. The stock is currently trading at $4.30, down 36.70%.
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