Business
GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates
Engagement with FDA on GH001 IND complete response ongoingFull dataset from the Phase 2b clinical trial of GH001 in TRD reported in July 2025Long-term
About this update from Gh Research Plc
[{"type":"text","content":"Engagement with FDA on GH001 IND complete response ongoingFull dataset from the Phase 2b clinical trial of GH001 in TRD reported in July 2025Long-term clinical data on safety and efficacy from Open-Label Extension presented at ECNP in October 2025Cash, cash equivalents and marketable securities of $293.9 million as of September 30, 2025 DUBLIN, Nov. 06, 2025 (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 financial results for the quarter ended September 30, 2025, and provided updates on its business. Business Updates GH001 Update In July 2025, we announced that we received a communication from the U.S. Food and Drug Administration (FDA) relating to our complete response to the clinical hold of our Investigational New Drug Application (IND) for GH001, with only one hold topic remaining. We are actively working with experts to address the remaining topic and engagement with the FDA on our IND complete response is ongoing. Final Data from Fully Completed Phase 2b TRD In July 2025, we reported on the full dataset from the Phase 2b clinical trial of GH001 in treatment-resistant depression (TRD) (GH001-TRD-201). The primary endpoint was met with a highly significant placebo adjusted reduction from baseline of -15.5 points in Montgomery-Åsberg Depression Rating Scale (MADRS) total score on Day 8 (p","length":2398,"tagName":"div"}]