Aardvark Therapeutics paused two Phase II studies of its oral weight‑loss asset ARD‑201 and put its broader pipeline on hold while it conducts a comprehensive data review and engages the FDA. ARD‑201 combines a gut‑targeting taste receptor agonist with a DPP4 inhibitor; the move follows an earlier voluntary pause of ARD‑101 due to reversible cardiac observations at supratherapeutic doses. CEO Tien Lee emphasized prioritizing patient safety and said the company is urgently engaging regulators to determine next steps. The combined pauses have already weighed on Aardvark’s market valuation and operational outlook. The decision underscores investor and regulatory scrutiny of novel metabolic and gut‑targeting approaches and raises questions about dose margins, cardiac monitoring, and the path to safely re‑initiating trials.
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