Aardvark Therapeutics Shares Plunge After FDA Hold on ARD-101 New Drug Application

Published: 2026-05-15 10:56:24 ET AARD

Published on 05/15/2026 at 10:56 am EDT

By Christopher Kuo

Aardvark Therapeutics shares plunged after the Food and Drug Administration placed a full clinical hold on the company's investigational new-drug application for ARD-101, Aardvark's treatment for a rare genetic disorder characterized by insatiable hunger, Prader-Willi syndrome.

Shares of the biopharmaceutical company fell 23% on Friday to $5.18. The company's shares are down 61% year to date.

The FDA's clinical hold applies to all ongoing clinical studies under the NDA, including the Phase 3 Hero trial, Aardvark said. The company is in talks with the FDA to try to resolve the hold and determine a path forward for the ARD-101 program, the company said.

In February, Aardvark had voluntarily paused its Phase 3 Hero trial and open-label extension trials evaluating ARD-101. The pause came after the company saw unexpected reversible cardiac observations in a separate healthy-volunteer trial, the company said.

Aardvark plans to unblind the clinical data from these trials. As of Feb. 27, it had dosed 68 patients in the randomized controlled Hero trial and 19 patients in the Ole trial, it said.

Write to Christopher Kuo at [email protected]

(END) Dow Jones Newswires

05-15-26 1055ET