GH Research’s GH001 Phase 2b Trial Shows 57.5% Day-8 Remission, Cash Hits $280.7M
GH Research PLC ended 2025 with $280.7 million in cash and marketable securities, up from $182.6 million a year earlier, and reported net loss of $48.3 million ($0.79 per share). Its Phase 2b GH001 trial in treatment-resistant depression delivered a placebo-adjusted 15.5-point MADRS reduction and gained FDA clearance for U.S. investigation.
1. Phase 2b Trial Success
GH Research PLC completed its Phase 2b GH001-TRD-201 trial in treatment-resistant depression, achieving a placebo-adjusted 15.5-point reduction on the MADRS at Day 8 (p<0.0001). 57.5% of patients reached remission by Day 8 versus 0% on placebo, and open-label extension showed a 73% six-month remission with no serious adverse events.
2. FDA Clearance and Phase 3 Plans
The U.S. Food and Drug Administration cleared GH001 for U.S. clinical investigation, paving the way for subject enrollment and initiation of a global Phase 3 pivotal program. GH Research is engaging with FDA to align on a program replicating the successful Phase 2b design, with initiation targeted for 2026.
3. Financial Highlights
As of December 31, 2025, GH Research held $280.7 million in cash and marketable securities, up from $182.6 million a year earlier. Full-year research and development expenses rose to $38.8 million and general and administrative expenses to $22.0 million, resulting in a net loss of $48.3 million ($0.79 per share).
4. Proprietary Device Development
GH Research advanced its proprietary aerosol delivery device through a Phase 1 pharmacology trial in healthy volunteers, aiming to bridge from the current commercial device to the new system. The company plans to deploy the proprietary device in its upcoming pivotal trials for GH001.