By Katherine Hamilton
Aardvark Therapeutics is voluntarily pausing a Phase 3 trial of a drug to treat hyperphagia in patients with Prader-Willi Syndrome.
The biopharmaceutical company said it is pausing the trial after finding reversible cardiac observations at above target therapeutic doses in a healthy volunteer study.
The company no longer anticipates announcing topline data from the trial with a hunger elimination or reduction objective in the third quarter of 2026, it said. It plans to provide further guidance in the second quarter of this year.
Shares tumbled 57%, to $5.45, in after-hours trading Friday. Through the close, the stock was up 25% over the past three months.
Aardvark is conducting a comprehensive review of the data to inform next steps, it said. It has paused continuing enrollment and dosing out of an abundance of caution.
The trial is for ARD-101, which has demonstrated an ability to reduce hunger when used alone or in combination with currently available GLP-1 therapies. The FDA has granted ARD-101 orphan drug designation and rare pediatric disease designation for Prader-Willi Syndrome.
Prader-Willi is a rare genetic disorder which can result in hyperphagia, which is insatiable hunger.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
February 27, 2026 17:20 ET (22:20 GMT)
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