GH Research PLC(US:GHRS) Globenewswire·2026-01-05 12:00Core Insights - The FDA has lifted the clinical hold on GH Research PLC's Investigational New Drug Application for GH001, allowing U.S. subject enrollment and advancing the company's development plans [1][2][8] - GH001 is positioned as a potential ultra-rapid and durable treatment option for patients with treatment-resistant depression (TRD), with a global pivotal program expected to initiate in 2026 [2][8] - The Phase 2b trial results indicate a significant reduction in depression symptoms, with a placebo-adjusted MADRS reduction of -15.5 points on Day 8, and 57.5% of patients achieving ultra-rapid remission [6][9] Company Overview - GH Research PLC is a clinical-stage biopharmaceutical company focused on developing innovative treatments for depression, specifically targeting treatment-resistant depression [5] - The lead product candidate, GH001, utilizes a proprietary inhalation method for mebufotenin administration, aiming to change the treatment landscape for TRD [6] Clinical Trial Highlights - The Phase 2b trial (GH001-TRD-201) met its primary endpoint, demonstrating a statistically significant reduction in depression symptoms [6][9] - Key findings from the trial include a 73% remission rate at 6 months with an average of approximately 4 treatments, a median psychoactive experience duration of ~11 minutes, and 99% of patients being discharge-ready within 1 hour of dosing [9]