Aardvark Therapeutics, Inc. 8-K

What Happened

• On February 10, 2026, Aardvark Therapeutics, Inc. (AARD) announced via press release (filed as Exhibit 99.1) that a U.S. Institutional Review Board (IRB) has approved an amended protocol to its ongoing Phase 3 HERO pivotal trial of ARD-101 for hyperphagia in Prader‑Willi Syndrome.
• The amended protocol, which Aardvark submitted to the U.S. Food and Drug Administration, lowers the trial’s minimum eligible age from 10 years to 7 years.

Key Details

• Event date: February 10, 2026 (press release and 8-K filing).
• Trial: Phase 3 HERO pivotal clinical trial evaluating ARD-101 for hyperphagia in Prader‑Willi Syndrome.
• Protocol change: Minimum age of eligibility reduced from 10 to 7 years.
• Regulatory steps: Amended protocol received IRB approval in the U.S. and was submitted to the FDA.

Why It Matters

• Lowering the minimum age expands the pool of eligible pediatric participants, which may help patient enrollment and the overall conduct of the Phase 3 trial.
• For investors, the change is a clinical development milestone: it reflects regulatory progress (IRB approval) and ongoing engagement with the FDA, both of which are relevant to the timing and execution of the company’s pivotal study for ARD‑101.