regulatory
confidence high
sentiment positive
materiality 0.65
Aardvark Therapeutics expands Phase 3 HERO trial age eligibility to 7+ years for ARD-101 in PWS
Aardvark Therapeutics, Inc.
- IRB approved amended protocol lowering minimum age from 10 to 7 years for Phase 3 HERO trial evaluating ARD-101.
- Amended protocol submitted to FDA; enrollment on track for topline data in Q3 2026.
- Trial targets 90 patients across US, Australia, Canada, UK, and South Korea.
- Primary endpoint: change in HQ-CT score at 12 weeks; open-label extension offered to completers.