GH Research says FDA lifts clinical hold on GH001

GH Research (GHRS) announced that the U.S. Food and Drug Administration has lifted the clinical hold on its Investigational New Drug Application for GH001. This clearance enables U.S. subject enrollment and progresses the company toward alignment of its development across major jurisdictions. “The FDA clearance is a major milestone and positions us to advance GH001 as a potential ultra-rapid and durable treatment option for TRD patients,” said Dr. Velichka Valcheva, CEO. “We continue to expect initiation of our global pivotal program in 2026. We look forward to meeting with the FDA to align on the design for the pivotal Phase 3 program.”