regulatory
confidence high
sentiment positive
materiality 0.60
Aardvark gets FDA alignment to lower Phase 3 PWS trial min age to 10
Aardvark Therapeutics, Inc.
- FDA aligned on protocol amendment for Phase 3 HERO trial of ARD-101, lowering minimum age from 13 to 10 years old.
- Expansion broadens patient population in Prader-Willi Syndrome; topline data readout expected in Q3 2026.
- CEO cites community support and historical data suggesting younger patients benefit from early intervention.