Aardvark Therapeutics Pauses Lead Phase 3 Drug Trial Over Cardiac Safety Signals
Summary
Aardvark Therapeutics announced a voluntary pause in enrollment and dosing for its Phase 3 HERO and OLE trials evaluating ARD-101 for Prader-Willi Syndrome, as well as its ARD-201 obesity program. This decision follows unexpected, reversible cardiac QRS prolongation observed in a separate healthy volunteer study, particularly at high doses. This is a significant setback for the clinical-stage biopharmaceutical company, introducing substantial uncertainty and delays for its lead pipeline candidates. While the company notes the effects were reversible and dose-dependent, the halt of a Phase 3 trial due to safety concerns creates considerable regulatory risk. Investors will be closely watching for further guidance from the company and the FDA, expected in Q2 2026, which will be a critical catalyst.
At the time of this announcement, AARD was trading at $4.07 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $88.5M. The 52-week trading range was $4.01 to $17.94. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.