Core Insights - Needham initiated coverage on GH Research PLC, highlighting the efficacy of its lead drug candidate, GH-001, in Phase 2 trials compared to competitors [1] Company Developments - GH Research submitted a complete response to the FDA regarding the clinical hold on the Investigational New Drug Application (IND) for GH-001, with only one hold topic remaining related to respiratory tract histology findings in rats [2] - There are no additional requests from the FDA concerning dog toxicology or device-related issues [3] Clinical Trial Results - Initial results from the Phase 2b clinical trial of GH-001 in treatment-resistant depression showed a 73% remission rate at six months, with 57.5% of patients achieving remission by day eight and 90% at month six [4] Analyst Insights - Needham assigned a Buy rating with a price forecast of $19 for GH Research, estimating that GH-001 could generate $1.9 billion in U.S. sales by 2035, applying a 35% probability of success to account for risks [5] - The enterprise value of GH Research is currently at $500 million, indicating potential long-term upside [6]