Clinical EfficacyPhase 2b and open‑label extension data demonstrated rapid, durable remission with infrequent clinic visits and a favorable safety profile, supporting potential market differentiation versus competitors.
Financial RunwayGHRS reported approximately $293.9 million in cash and marketable securities, providing a financial runway to support a planned 2026 pivotal trial.
Regulatory ClearanceFDA lifted the clinical hold on GH001, enabling initiation of a Phase 3 program and removing a major regulatory overhang for the asset.