FDA places clinical hold on Aardvark’s Prader-Willi drug amid heart safety concerns

The Food and Drug Administration has issued a clinical hold on Aardvark Therapeutics' experimental treatment ARD-101 for Prader-Willi Syndrome after safety signals were identified.

The hold follows detection of potential heart problems in a separate safety study involving healthy volunteers who received doses higher than those used in disease trials.

Aardvark said it will unblind the ongoing Phase 3 trial, which has dosed 68 participants, and an open-label extension with 19 participants, to identify which subjects received ARD-101 and assess safety.

The news sent the company's shares down as much as 36% in morning trading, with the stock trading just above $5, roughly half its price before the issue emerged.