Business
GH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates
Global pivotal program initiation on track for 2026Engagement with FDA on GH001 IND complete response ongoingThe fully completed Open-Label Extension analysis
About this update from Gh Research Plc
[{"type":"text","content":"Global pivotal program initiation on track for 2026Engagement with FDA on GH001 IND complete response ongoingThe fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no psychotherapyTreatment was well tolerated and no treatment related serious adverse events were reported. There was no evidence of treatment-emergent suicidal ideation or behaviorCash, cash equivalents and marketable securities of $308.7 million as of June 30, 2025 DUBLIN, Aug. 07, 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 June 30, 2025, and provided updates on its business. Business Updates GH001 Update We recently 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. Engagement with the FDA on our IND complete response is ongoing. We are actively working on a plan with our respiratory, toxicology and regulatory experts to address the remaining topic. GH001 Administered with Proprietary Aerosol Delivery Device Our Phase 1 clinical pharmacology trial to evaluate our proprietary aerosol delivery device for administration of GH001 in healthy volunteers (GH001-HV-106) is ongoing in the United Kingdom. This trial is designed to support our global program for GH001, by bridging to the clinical data generated with the commercially available device that we have used in our clinical trials to date. Final Data from Fully Completed Phase 2b TRD We recently 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":3093,"tagName":"div"}]