By Katherine Hamilton

Aardvark Therapeutics' drug application for ARD-101, a treatment for people with the genetic disorder Prader-Willi Syndrome, was placed on clinical hold by the Food and Drug Administration.

The clinical-stage biopharmaceutical company said after the close Thursday the hold applies to all ongoing clinical studies under the application, including two Phase 3 trials.

Shares slid 14% to $5.82 in post-market trading.

The hold was related to Aardvark's voluntary pause of one of the Phase 3 trials in February, which it said at the time was due to safety issues in the study.

Aardvark is in talks with the FDA to resolve the hold and determine a path forward for ARD-101, it said. The company also plans to unblind the clinical data from both trials to assess efficacy and safety, which it said will help decide next steps for the program.

ARD-101 is designed to suppress hunger for the treatment of Prader-Willi Syndrome and metabolic diseases.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

May 14, 2026 17:08 ET (21:08 GMT)

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