Core Insights - The FDA lifted the clinical hold on GH Research Plc's Investigational New Drug Application for GH001, marking a significant milestone for the company [1][2] - GH001 is positioned as a potential ultra-rapid and durable treatment option for treatment-resistant depression (TRD) patients, with a global pivotal program expected to initiate in 2026 [2] - The Phase 2b trial of GH001 demonstrated a significant reduction in depression scores, indicating its efficacy compared to placebo [3][4] Company Developments - Dr. Velichka Valcheva, CEO of GH Research, expressed optimism about advancing GH001 following FDA clearance and plans to align with the FDA on the Phase 3 program design [2] - The Phase 2b trial results showed a reduction of -15.2 points in the Montgomery-Åsberg Depression Rating Scale total score on Day 8 for GH001, compared to a +0.3 points change in the placebo group [3] Competitive Landscape - Johnson & Johnson's Spravato (esketamine) was approved by the FDA as the first monotherapy for adults with major depressive disorder who did not respond adequately to at least two oral antidepressants [5] - Alto Neuroscience acquired Chase Therapeutics' portfolio for over $100 million, indicating ongoing investment in treatment-resistant depression solutions [6] - Atai Life Sciences and Beckley Psytech Limited are conducting studies on alternative treatments for TRD, highlighting the competitive environment in this sector [6] Market Reaction - GH Research shares experienced a significant increase of 34.52%, reaching $17.86 following the FDA's announcement [7]