FDA Has Lifted The Clinical Hold On GH Research's Investigational New Drug Application For GH001, Phase 3 Initiation Targeted For 2026

Benzinga · 6d ago
  • GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment
  • Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design
  • Phase 3 initiation targeted for 2026