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GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD

DUBLIN, March 25, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression (TRD): the primary trial results in  JAMA Psychiatry , and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin.

GH Research Reports Full Year 2025 Financial Results and Provides Business Update

Completed Phase 2b trial of GH001 in TRD and presented the full dataset at the 2025 ASCP and ECNP congresses GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Cash, cash equivalents and marketable securities of $280.7 million as of December 31, 2025 DUBLIN, Ireland, March 05, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the year ended December 31, 2025, and provided a business update. Business Update In 2025, the Company completed its Phase 2b trial of GH001 in treatment-resistant depression (TRD) and presented the full dataset at the 2025 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting in Arizona, and the 2025 European College of Neuropsychopharmacology (ECNP) Congress in Amsterdam.

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

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 DUBLIN, Jan. 05, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug Application (IND) for GH001. This clearance enables U.S. subject enrollment and progresses the company toward alignment of its development across major jurisdictions.

GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates

Engagement with FDA on GH001 IND complete response ongoing Full dataset from the Phase 2b clinical trial of GH001 in TRD reported in July 2025 Long-term clinical data on safety and efficacy from Open-Label Extension presented at ECNP in October 2025 Cash, cash equivalents and marketable securities of $293.9 million as of September 30, 2025 DUBLIN, Nov. 06, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the quarter ended September 30, 2025, and provided updates on its business. Business Updates GH001 Update In July 2025, we announced that we received a communication from the U.S. Food and Drug Administration (FDA) relating to our complete response to the clinical hold of our Investigational New Drug Application (IND) for GH001, with only one hold topic remaining.