Welcome to our dedicated page for Gh Research news (Ticker: GHRS), a resource for investors and traders seeking the latest updates and insights on Gh Research stock.
GH Research PLC develops clinical-stage mebufotenin therapies for depression, with an initial focus on treatment-resistant depression. News about GHRS centers on GH001, its proprietary inhaled mebufotenin product candidate, including clinical trial results, peer-reviewed publications, medical-conference presentations, and FDA/IND regulatory updates.
Company updates also reference GH002, its proprietary intravenous mebufotenin product candidate, and broader clinical work across depressive disorders. Recurring financial and corporate items include full-year and quarterly results, cash and capital-structure disclosures, shareholder voting matters, and business updates tied to the company’s research and development segment.
GH Research (GHRS) announced successful results from two Phase 2a proof-of-concept trials for GH001. The first trial in postpartum depression (PPD) showed a significant MADRS score reduction of -35.4 points with 100% of patients achieving remission by Day 8. The second trial in bipolar II disorder (BDII) demonstrated a MADRS reduction of -16.8 points with 33.3% of patients in remission by Day 8.
The company completed FDA-requested inhalation toxicology studies in dogs showing no respiratory tract findings, supporting their position that previous findings were rat-specific. GHRS plans to submit a full response to the FDA's IND hold in mid-2025. Their Phase 2b trial in treatment-resistant depression remains on track with top-line data expected in Q1 2025.
The company's financial position remains strong with $182.6 million in cash and equivalents as of December 31, 2024, compared to $222.7 million the previous year.
GH Research has completed enrollment for its Phase 2b trial of GH001 (inhaled mebufotenin) in treatment-resistant depression, with top-line data expected by Q1 2025. The company reported $193.8 million in cash and equivalents as of September 30, 2024, down from $222.7 million at end-2023. Q3 2024 saw increased R&D expenses of $8.4 million (vs $7.1M in Q3 2023) and G&A expenses of $4.2 million (vs $2.6M in Q3 2023), resulting in a net loss of $12.1 million ($0.23 per share). The FDA clinical hold on GH001's IND continues, with ongoing nonclinical studies addressing inhalation toxicology concerns.
GH Research PLC (Nasdaq: GHRS) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Phase 2b trial of GH001 for treatment-resistant depression (TRD) on track for completion in Q3 2024.
2. Phase 1 trial for proprietary aerosol delivery device approved in the UK and recruiting.
3. Cash position of $204.5 million as of June 30, 2024.
4. R&D expenses increased to $9.8 million in Q2 2024 from $7.2 million in Q2 2023.
5. Net loss of $10.4 million ($0.20 per share) in Q2 2024 compared to $7.7 million ($0.15 per share) in Q2 2023.
6. FDA clinical hold on GH001 IND continues, with ongoing nonclinical studies to address inhalation toxicology concerns.
GH Research PLC (Nasdaq: GHRS) has announced the promotion of Dr. Velichka "Villy" Valcheva to Chief Executive Officer, succeeding co-founder PD Dr. med. Theis Terwey. Dr. Valcheva, who joined the company in August 2023 and has served as Chief Medical Officer since February 2024, brings over 20 years of pharmaceutical and biotech industry leadership experience.
The company is currently screening patients for its phase 2b trial in treatment-resistant depression, with enrollment expected to complete in September 2024. Additionally, a phase 1 healthy volunteer study using GH Research's proprietary device is actively enrolling in the UK. These developments signify the company's progress in its mission to transform the treatment of psychiatric and neurological disorders.
GH Research PLC reported financial results for Q1 2024, with cash reserves of $214.0 million expected to last until 2026. The Phase 2b trial of GH001 for treatment-resistant depression is progressing, with top-line data expected in late 2024. GH002, the intravenous product candidate, showed promising results in a Phase 1 trial. The company provided updates on IND for GH001 and financial highlights.
Summary not available.
Summary not available.
Summary not available.
Summary not available.
Summary not available.