$AARD·8-K

Aardvark Therapeutics, Inc. · Feb 27, 4:27 PM ET

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Aardvark Therapeutics, Inc. 8-K

Research Summary

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Aardvark Therapeutics Pauses Phase 3 HERO Trial (ARD-101)

What Happened
On February 27, 2026, Aardvark Therapeutics, Inc. announced by press release (filed as Exhibit 99.1 to a Form 8‑K) that it is voluntarily pausing 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. The Form 8‑K was signed by CEO Tien‑Li Lee, M.D.

Key Details

  • Announcement and filing date: February 27, 2026; press release included as Exhibit 99.1 to the Form 8‑K.
  • Trial paused: Phase 3 HERO trial of ARD‑101 (Hunger Elimination or Reduction Objective).
  • Trial design and indication: randomized, double‑blind, placebo‑controlled study for hyperphagia in Prader‑Willi Syndrome.
  • Form 8‑K executed by CEO Tien‑Li Lee, M.D.

Why It Matters
The filing confirms a voluntary pause in late‑stage clinical development for ARD‑101; the company’s 8‑K does not state the reason for the pause. A pause in a Phase 3 trial stops enrollment and data collection and can change the timing of clinical readouts and any subsequent regulatory submissions. Investors should monitor Aardvark’s future press releases, SEC filings, and clinical trial registry updates for the cause of the pause, impacts on timelines, and any plans for resumption.

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