Aardvark Therapeutics pauses Phase 3 HERO trial for ARD-101 in PWS due to cardiac signals

Aardvark Therapeutics, Inc.

Voluntary pause of Phase 3 HERO trial (NCT06828861) and open-label extension (NCT07197034) for ARD-101 in Prader-Willi Syndrome.
Decision based on reversible cardiac observations at above-target therapeutic doses in a healthy volunteer study.
No longer expects topline data in Q3 2026; plans to provide guidance in Q2 2026.
Company conducting comprehensive data review and collaborating with FDA and clinical experts.

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