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GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD
Globenewswire· 2026-03-25 15:10
Phase 2b results for GH001 in TRD now published and peer-reviewed in JAMA Psychiatry New peer-reviewed article in forthcoming issue of Psychopharmacology Bulletin demonstrates that GH001 efficacy is independent of prior antidepressant treatment failures DUBLIN, March 25, 2026 (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 announced two peer-reviewed ...
GH Research FY25 Results: Strong Cash Position As GH001 Advances Toward Phase 3
Seeking Alpha· 2026-03-10 21:28
Core Insights - GH Research PLC (GHRS) reported a fiscal year 2025 GAAP EPS of -$0.79, which aligns with expectations due to ongoing investments in clinical development [1] - The company ended the year with a solid cash position, indicating financial stability despite the negative EPS [1] Company Overview - GH Research is focused on clinical development within the biotechnology sector, emphasizing innovative therapies and unique mechanisms of action [1] - The firm combines scientific expertise with financial analysis to evaluate drug candidates and their market potential [1] Investment Focus - The analysis highlights the importance of understanding the science behind drug candidates, competitive landscape, clinical trial design, and market opportunities [1] - The biotechnology sector is characterized by the potential for significant returns through breakthrough science, necessitating careful scrutiny of investment opportunities [1]
GH Research PLC(GHRS) - 2025 Q4 - Annual Report
2026-03-05 12:10
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Copies ...
GH Research Reports Full Year 2025 Financial Results and Provides Business Update
Globenewswire· 2026-03-05 12:00
Core Viewpoint - GH Research PLC has reported significant progress in its clinical development of GH001 for treatment-resistant depression (TRD), with promising Phase 2b trial results and a strong financial position as of the end of 2025 [1][2][5]. Business Update - The company completed its Phase 2b trial of GH001 in TRD and presented the full dataset at major conferences in 2025 [2]. - GH Research is seeking FDA alignment for its global Phase 3 pivotal program, which aims to replicate the Phase 2b study [2]. Clinical Trial Results - The Phase 2b trial achieved its primary endpoint with a placebo-adjusted Montgomery-Åsberg Depression Rating Scale (MADRS) reduction of -15.5 points at Day 8 (p<0.0001) [3]. - 57.5% of patients on GH001 achieved remission (MADRS ≤10) at Day 8 compared to 0% on placebo [3]. - The open-label extension showed a 73% remission rate at six months with infrequent retreatment visits and no mandated psychotherapy [3]. - Safety results were favorable, with no treatment-related serious adverse events reported [3]. Financial Highlights - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $280.7 million, up from $182.6 million in 2024 [5]. - Research and development expenses increased to $38.8 million in 2025 from $35.0 million in 2024, primarily due to technical development and employee expenses [6]. - General and administrative expenses rose to $22.0 million in 2025 from $15.3 million in 2024, driven by increased professional fees and employee expenses [7]. - The net loss for 2025 was $48.3 million, or $0.79 per share, compared to a net loss of $39.0 million, or $0.75 per share, in 2024 [8]. Product Development - GH001 is formulated for mebufotenin administration via a proprietary inhalation approach, with the potential to change TRD treatment [10]. - The company is also developing GH002, a mebufotenin product candidate for intravenous administration, having completed a Phase 1 trial in healthy volunteers [11].
GH Research (NasdaqGM:GHRS) Earnings Call Presentation
2026-03-05 12:00
Ultra-Rapid, Durable Remission in TRD with Minimal Clinic Burden GH Research PLC (Nasdaq: GHRS) March 2026 2026© GH Research PLC 1 Disclaimer Regarding Forward-Looking Statements This presentation has been prepared by GH Research PLC ("GH Research"). Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the presenter or GH Research or any director, employee, agent, or adviser of GH Research. This presentation does not purport to be all-inclusive ...
RBC Capital Cite GH Research PLC’s (GHRS) Long-Term Sales Potential Following Psychedelics Symposium
Yahoo Finance· 2026-02-19 02:30
Core Insights - GH Research PLC (NASDAQ:GHRS) is recognized as one of the 7 most promising psychedelic stocks according to hedge funds [1] - RBC Capital has raised its price target for GHRS to $40 from $33, maintaining an Outperform rating, citing increased optimism about the company's long-term sales potential, particularly for GH001 [2] - The FDA lifted the clinical hold on GH001, allowing U.S. patient enrollment and advancing global development plans, with a key Phase 3 program expected to launch in 2026 [3] Company Overview - GH Research PLC is a biotech company focused on developing innovative psychedelic-derived therapies aimed at treating mental health disorders through rigorous clinical research and evidence-based approaches [4] Clinical Developments - Phase 2b results for GH001 showed that 73% of patients maintained remission at six months with infrequent dosing, and 57.5% experienced remission by Day 8, indicating its potential as a transformative therapy for treatment-resistant depression [3]
GH Research PLC (NASDAQ: GHRS) Targets Mental Health Disorders with Innovative Treatments
Financial Modeling Prep· 2026-01-05 22:05
Company Overview - GH Research PLC (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company focused on developing innovative treatments for mental health disorders, specifically advancing GH001, an inhalable bufotenin product candidate for treatment-resistant depression (TRD) [1][6] - Competitors include other biopharmaceutical companies such as Compass Pathways and MindMed [1] Recent Developments - On January 5, 2026, Eddie Hickman from Guggenheim set a price target of $29 for GHRS, indicating a potential upside of approximately 83.5% from the current stock price of $15.80, with a Buy rating reiterated following a management call [2] - The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on GH Research's Investigational New Drug Application (IND) for GH001, allowing the company to advance its global pivotal program in 2026 [3] - In February 2025, GH Research announced that its Phase 2b trial for GH001 successfully met its primary endpoint, showing a significant reduction of 15.2 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline on Day 8, compared to an increase of 0.3 points in the placebo group [4] Stock Performance - The stock for GHRS is currently priced at $15.78, reflecting a significant increase of 19.18% with a change of $2.54, and has fluctuated between a low of $15.59 and a high of $19 today [5] - Over the past year, GHRS has reached a high of $20.50 and a low of $7.98, with a market capitalization of approximately $978.8 million and a trading volume of 4,619,702 shares [5]
Dow Jumps 800 Points; ISM Manufacturing PMI Falls In December - GH Research (NASDAQ:GHRS), Momentus (NASDAQ:MNTS)
Benzinga· 2026-01-05 18:54
Market Performance - U.S. stocks experienced gains, with the Dow Jones index increasing by 1.66% to 49,183.51, the NASDAQ rising by 0.80% to 23,420.85, and the S&P 500 up by 0.81% to 6,913.76 [1] - European shares also saw positive movement, with the eurozone's STOXX 600 gaining 0.94%, Spain's IBEX 35 Index rising by 0.70%, London's FTSE 100 up by 0.54%, Germany's DAX increasing by 1.34%, and France's CAC 40 climbing by 0.20% [5] - Asian markets closed mostly higher, highlighted by Japan's Nikkei 225 gaining 2.97% and China's Shanghai Composite surging 1.38%, while India's BSE Sensex fell by 0.38% [6] Commodity Prices - In commodity trading, oil prices increased by 1.7% to $58.30, gold rose by 2.9% to $4,454.40, silver surged by 7.3% to $76.230, and copper climbed by 5.1% to $5.9815 [4] Company Developments - Momentus Inc (NASDAQ:MNTS) shares surged by 57% to $8.98 following the announcement of an additive-manufactured fuel tank for flight testing [8] - GH Research PLC (NASDAQ:GHRS) shares increased by 17% to $15.43 after the FDA lifted the clinical hold on its Investigational New Drug Application for GH001 [8] - VerifyMe Inc (NASDAQ:VRME) shares rose by 66% to $1.12 due to a strategic merger letter of intent with Open World [8] - Zenas Biopharma Inc (NASDAQ:ZBIO) shares dropped by 57% to $14.94 after announcing results from the Phase 3 INDIGO trial [8] - Palisade Bio Inc (NASDAQ:PALI) shares fell by 16% to $2.10, and Palvella Therapeutics Inc (NASDAQ:PVLA) decreased by 14% to $86.16 [8] Economic Indicators - The ISM manufacturing PMI declined for the third consecutive month to 47.9 in December, marking the lowest reading since October 2024, down from 48.2 in November and below market estimates of 48.3 [2][7]
Altimmune, GH Research, Gyre Therapeutics And Other Big Stocks Moving Higher On Monday - Aduro Clean Technologies (NASDAQ:ADUR), Allegro Microsystems (NASDAQ:ALGM)
Benzinga· 2026-01-05 15:09
Market Overview - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 500 points on Monday [1] Company Highlights - Altimmune Inc (NASDAQ:ALT) saw a significant increase of 23.6%, reaching $4.34, following the FDA's grant of Breakthrough Therapy Designation for Pemvidutide in MASH [1] - GH Research PLC (NASDAQ:GHRS) surged by 33.8% to $17.72 after the FDA lifted the clinical hold on its Investigational New Drug Application for GH001 [2] - Vicor Corp (NASDAQ:VICR) rose by 20.7% to $141.08 [2] - Critical Metals Corp (NASDAQ:CRML) increased by 19.6% to $9.71 [2] - Kosmos Energy Ltd (NYSE:KOS) gained 19.3% to $1.06 after issuing an operational and financial update [2] - TRON Inc (NASDAQ:TRON) increased by 16.9% to $1.59 [2] - Nuscale Power Corp (NYSE:SMR) rose by 15.7% to $18.88 [2] - Regencell Bioscience Holdings Ltd (NASDAQ:RGC) increased by 15.4% to $23.71 [2] - Rayonier Advanced Materials Inc (NYSE:RYAM) gained 14.1% to $6.68, with the appointment of Scott M. Sutton as President and CEO [2] - Aduro Clean Technologies Inc (NASDAQ:ADUR) rose by 14% to $12.05 [2] - Gyre Therapeutics Inc (NASDAQ:GYRE) increased by 12.7% to $7.67, announcing alignment with China's CDE on conditional approval pathway for hydronidone [2] - Endeavour Silver Corp (NYSE:EXK) gained 12.5% to $10.16 [2] - Allegro MicroSystems Inc (NASDAQ:ALGM) surged by 11.9% to $30.12 [2] - United States Antimony Corp (NYSE:UAMY) rose by 11.7% to $6.69 [2] - Oklo Inc (NYSE:OKLO) gained 11.5% to $86.82 [2] - Figure Technology Solutions Inc (NASDAQ:FIGR) increased by 11.3% to $48.66 [2] - Valero Energy Corp (NYSE:VLO) rose by 9.6% to $181.21 [2] - AeroVironment, Inc. (NASDAQ:AVAV) increased by 8.6% to $278.31 [2] - Coeur Mining Inc (NYSE:CDE) gained 8.5% to $19.05 [2] - Halliburton Co (NYSE:HAL) rose by 7.8% to $31.92, with U.S. energy stocks trading higher amid news of potential investments in Venezuela's oil industry [2] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) gained 7.7% to $85.39 [2] - Slb NV (NYSE:SLB) increased by 7.4% to $43.19 [2] - Amkor Technology Inc (NASDAQ:AMKR) rose by 7.3% to $46.05, with Needham analyst Charles Shi maintaining a Buy rating and raising the price target from $37 to $50 [2]
US Stocks Higher; Dow Jumps 250 Points - GH Research (NASDAQ:GHRS), Lavoro (NASDAQ:LVRO)
Benzinga· 2026-01-05 14:50
Market Overview - U.S. stocks traded higher, with the Dow Jones index gaining over 250 points, up 0.54% to 48,641.58, NASDAQ up 0.65% to 23,386.57, and S&P 500 up 0.63% to 6,901.52 [1] - Energy shares increased by 2.9% on Monday [1] Sector Performance - Consumer staples stocks dipped by 0.4% [2] Commodity Prices - Oil traded up 1.4% to $58.12, gold up 2.4% to $4,433.50, silver up 7.5% to $76.320, and copper rose 4.1% to $5.9260 [5] European Market Performance - Eurozone's STOXX 600 gained 0.5%, Spain's IBEX 35 Index rose 0.3%, London's FTSE 100 up 0.4%, Germany's DAX gained 0.2%, and France's CAC 40 climbed 0.1% [6] Asian Market Performance - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 2.97%, Hong Kong's Hang Seng Index up 0.03%, China's Shanghai Composite surging 1.38%, while India's BSE Sensex fell 0.38% [7] Company News - The FDA lifted the clinical hold on GH Research Plc's Investigational New Drug Application for GH001 [3] - Momentus Inc shares surged 94% to $11.14 after announcing the development of an additive-manufactured fuel tank [9] - TMD Energy Ltd shares increased by 76% to $0.78 [9] - VerifyMe Inc shares rose 40% to $0.94 following a strategic merger announcement [9] - Zenas Biopharma Inc shares dropped 55% to $15.54 after Phase 3 trial results [9] - Signing Day Sports Inc shares fell 37% to $0.60, and Lavoro Ltd shares decreased by 26% to $0.82 [9]