Aardvark Therapeutics Inc. (AARD) announced that it has voluntarily paused the Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The HERO study is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of ARD-101 as a treatment for hyperphagia in patients with Prader-Willi Syndrome (PWS).
The decision to pause both the HERO trial and its open-label extension was based on reversible cardiac observations at above-target therapeutic doses identified during routine safety monitoring in a healthy volunteer study. Aardvark is conducting a comprehensive review of the data to determine next steps. Out of caution, the company has suspended ongoing enrollment and dosing in the HERO trial while this evaluation is underway.
As a result of these developments, Aardvark no longer expects to announce topline data from the HERO trial in the third quarter of 2026. Instead, the company plans to provide updated guidance in the second quarter of this year, once the review of the ARD-101 program is complete.
Aardvark Therapeutics shares closed the regular trading session at $12.49, down $0.01 or -0.08% as of 4:00:03 PM EST. In after-hours trading, the stock experienced a sharp decline, falling to $6.58, a drop of $5.91 or -47.32% as of 7:59:37 PM EST.
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