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The U.S. Food and Drug Administration (FDA) on Monday lifted the clinical hold on GH Research Plc's (NASDAQ: GHRS) Investigational New Drug Application (IND) for GH001.

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…

U.S. stock futures rose in the first full trading week of the year on Monday after closing mixed on Friday. Futures of major benchmark indices were higher.

GH Research is advancing GH001, an inhaled mebufotenin therapy for treatment-resistant depression, with a critical FDA IND update imminent. GH001 demonstrated robust Phase 2b efficacy—a 15.5-point MADRS reduction at Day 8 and 73% six-month remission—with infrequent dosing and strong safety. GHRS maintains a disciplined cost structure, $293.9M in cash, and a projected runway exceeding five years at current burn rates.

DUBLIN, Jan. 02, 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 that it will provide an update on the status of its Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA) and its global pivotal…