FDA lifts clinical hold on Aardvark's ARD-101 Prader-Willi study
- Cardiac safety signals had earlier led the FDA to place a full clinical hold on Aardvark Therapeutics' studies of ARD-101.
- The company then ran an additional safety study, which detected no cardiac events.
- Aardvark plans to resume testing of the candidate next year.
💡 Points
A full clinical hold lifted on the strength of one extra safety study with no cardiac events is a fast reversal, but it still leaves ARD-101 a year from restarting. Next year's resumption means Aardvark's Prader-Willi timeline slipped materially. The detail to watch is how regulators want cardiac monitoring built into the restart; the summary is silent on that.
FDA uncages Aardvark’s Prader-Willi study after new data cleared safety concerns ↗