Aardvark Therapeutics Expands Phase 3 HERO Trial for Prader-Willi Syndrome
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On October 8, 2025, Aardvark Therapeutics announced FDA alignment on expanding the Phase 3 HERO trial for Prader-Willi Syndrome.
Key Highlights:
- Minimum age for trial participation lowered from 13 to 10 years.
- Expansion aims to include a larger segment of the PWS patient population.
- Early intervention in younger patients may enhance treatment benefits.
- Topline data from the trial expected in Q3 2026.
- ARD-101 has Orphan Drug and Rare Pediatric Disease Designations.
Original SEC Filing: Aardvark Therapeutics, Inc. [ AARD ] - 8-K - Oct. 08, 2025
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