FDA lifts hold on Aardvark Therapeutics' ARD-101 after safety study shows no cardiac events
read at BioSpace ↗CRLPositive
FDA has lifted the clinical hold on Aardvark Therapeutics' ARD-101 after the company completed an additional safety study. The new data showed no cardiac events, addressing the concerns that prompted the original hold.
The hold was initially imposed after early signals suggested potential cardiac safety issues in the program. Those signals led regulators to pause all ongoing trials of the candidate.
With the safety issue resolved, Aardvark plans to restart testing of ARD-101 in the coming year.
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This writeup was produced by pharmadog from original reporting by BioSpace. The original article may no longer be reachable at its published URL.
Original headline: “FDA uncages Aardvark’s Prader-Willi study after new study cleared safety concerns”
read at BioSpace ↗
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