FDA Lifts Clinical Hold on GH Research's GH001, Allowing U.S. Trials
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GH Research plc announced that the FDA has lifted the clinical hold on its Investigational New Drug Application for GH001, allowing U.S. subject enrollment. This regulatory clearance paves the way for a global Phase 3 program targeting treatment-resistant depression, with initiation planned for 2026. The company aims to align with the FDA on the Phase 3 program design to replicate successful Phase 2b trial results.
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