GH001
Search documents
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
Core Insights - GH Research PLC has announced two peer-reviewed publications from its Phase 2b clinical program of GH001 for treatment-resistant depression (TRD), highlighting significant findings regarding the efficacy of GH001 [1][2][3] Publication Details - The primary trial results of GH001 have been published in JAMA Psychiatry, detailing the complete results from a randomized, double-blind, placebo-controlled Phase 2b trial, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from a 6-month open-label extension [2][3] - A supporting article demonstrating that GH001's efficacy is independent of prior treatment failures will be published in Psychopharmacology Bulletin [3] Efficacy Findings - The new analysis indicates that GH001 does not follow the established pattern of declining remission rates with successive treatment failures, as seen in the STAR*D trial [4] - Remission rates for GH001 were consistently high across subgroups with varying numbers of prior treatment failures, suggesting potential benefits for patients with extensive treatment histories [4][7] - Day 8 remission rates ranged from 53.9% to 63.6% for patients with 2 to ≥5 prior treatment failures, with Month 6 remission rates ranging from 61.5% to 85.7% [7] Product Information - GH001 is a proprietary mebufotenin therapy administered via inhalation, which has shown a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) by −15.5 points compared to placebo on Day 8 (P<0.0001) [9] - The company believes that GH001 has the potential to change the treatment landscape for TRD based on the observed clinical activity in the Phase 2b trial [6][9]
What Does GH Research PLC (GHRS)’s Clinical Progress Updates Say?
Yahoo Finance· 2026-03-25 05:34
Core Insights - GH Research PLC (NASDAQ:GHRS) is recognized as a leading psychedelic stock for investment in 2026, focusing on developing psychedelic medicines for conditions such as depression and bipolar II disorder [1] Financial Performance - In 2025, GH Research reported R&D expenditures of $38.8 million and general and administrative expenses of $22.0 million, ending the year with $280.7 million in cash, cash equivalents, and marketable securities [4] Clinical Progress - The company completed a Phase 2b trial of its lead drug candidate GH001 for treatment-resistant depression, achieving its primary endpoint, and is now advancing to a global Phase 3 study while seeking FDA alignment on the study design [5] - GH Research also completed a Phase 1 study for its other drug candidate, GH002, in healthy volunteers [5] Analyst Ratings - Guggenheim raised its price target for GH Research from $29 to $34, maintaining a Buy rating based on the company's financial results and clinical updates [3]
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 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]
Dow Jumps 800 Points; ISM Manufacturing PMI Falls In December
Benzinga· 2026-01-05 18:54
U.S. Stock Market Performance - U.S. stocks traded higher, with the Dow Jones index gaining more than 250 points, closing up 1.66% at 49,183.51 [1] - The NASDAQ increased by 0.80% to 23,420.85, and the S&P 500 rose by 0.81% to 6,913.76 [1] Sector Performance - Energy shares experienced a gain of 2.9% on Monday [1] - Utilities stocks saw a decline of 2.2% [1] Commodity Market - Oil prices rose by 1.7% to $58.30 [4] - Gold increased by 2.9% to $4,454.40 [4] - Silver surged by 7.3% to $76.230, while copper rose by 5.1% to $5.9815 [4] European Market Performance - European shares were higher, with the eurozone's STOXX 600 gaining 0.94% [5] - Spain's IBEX 35 Index rose by 0.70%, London's FTSE 100 increased by 0.54%, Germany's DAX gained 1.34%, and France's CAC 40 climbed 0.20% [5] Asian Market Performance - Asian markets closed mostly higher, with Japan's Nikkei 225 gaining 2.97% [6] - Hong Kong's Hang Seng Index increased by 0.03%, China's Shanghai Composite surged by 1.38%, while India's BSE Sensex fell by 0.38% [6] Company-Specific Developments - Momentus Inc (NASDAQ:MNTS) shares surged 57% to $8.98 following the announcement of an additive-manufactured fuel tank for flight testing [8] - GH Research PLC (NASDAQ:GHRS) shares rose 17% to $15.43 after the FDA lifted the clinical hold on its Investigational New Drug Application [8] - VerifyMe Inc (NASDAQ:VRME) shares increased by 66% to $1.12 due to a strategic merger letter of intent with Open World [8] - Zenas Biopharma Inc (NASDAQ:ZBIO) shares dropped 57% to $14.94 after announcing Phase 3 INDIGO trial results [8] - Palisade Bio Inc (NASDAQ:PALI) shares fell 16% to $2.10, and Palvella Therapeutics Inc (NASDAQ:PVLA) decreased by 14% to $86.16 [8]
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]