GH Research（1KA）株式概要GHリサーチPLCは、臨床段階のバイオ医薬品会社である子会社とともに、米国でうつ病の治療法の開発に取り組んでいる。 詳細1KA ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性6/6配当金0/6リスク分析収益が 100 万ドル未満 ( $0 )German市場と比較して、過去 3 か月間の株価の変動が非常に大きい現在は利益が出ておらず、今後3年間で利益が出る見込みはない すべてのリスクチェックを見る1KA Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW493,174 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeBLINROAG493,174 investors already sharing narrativesYour Fair Value€Current Price€23.20該当なし内在価値ディスカウントEst. Revenue$PastFuture-56m182016201920222025202620282031Revenue US$18.4Earnings US$2.7AdvancedSet Fair ValueView all narrativesGH Research PLC 競合他社Dermapharm HoldingSymbol: XTRA:DMPMarket cap: €2.4bPEPTONIC medicalSymbol: DB:28LMarket cap: €560.2mMPH Health CareSymbol: DB:93M1Market cap: €122.9mCantourage GroupSymbol: XTRA:HIGHMarket cap: €77.3m価格と性能株価の高値、安値、推移の概要GH Research過去の株価現在の株価US$23.2052週高値US$25.0052週安値US$9.75ベータ1.291ヶ月の変化14.85%3ヶ月変化87.10%1年変化88.62%3年間の変化105.31%5年間の変化n/aIPOからの変化60.04%最新ニュースお知らせ • Jun 04GH Research PLC Publishes Full Results from Phase 2A Trial in Postpartum Depression and Announces Acceptance of Two Oral Presentations At CINP 2026GH Research PLC announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026). The peer-reviewed article, titled “Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial,” has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284). The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD. Primary endpoint met: Mean Montgomery–Åsberg Depression Rating Scale (MADRS) reduction of -35.4 points from baseline to Day 8. 100% of patients (10/10) achieved remission (MADRS total score =10) within two hours of dosing, sustained through Day 8. Improved maternal functioning: Mean 34.1-point (56%) increase on the Barkin Index of Maternal Functioning at Day 8. Well-tolerated: No serious adverse events; all treatment-emergent adverse events mild or moderate; no treatment-emergent suicidal ideation or behavior. An analysis of breast milk supports a treatment strategy with only a brief interruption of breastfeeding around GH001 dosing. The Company also announced that two featured communications have been accepted for oral presentation at CINP 2026, to be held June 26–29, 2026 in Glasgow, United Kingdom. Both present data from the Phase 2b GH001-TRD-201 trial of GH001 in treatment-resistant depression (TRD).Board Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 1 highly experienced director. Independent Non-Executive Director Dermot Hanley was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • May 14+ 1 more updateGH Research PLC, Annual General Meeting, Jun 25, 2026GH Research PLC, Annual General Meeting, Jun 25, 2026. Location: joshua dawson house, dawson street, dublin 2, d02 ry95., Irelandお知らせ • May 01GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18 Discount Per Security: $0.9お知らせ • Apr 29GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18お知らせ • Mar 25GH Research plc Announces Publication of Phase 2B Results for Mebufotenin (Gh001) in Jama Psychiatry and Reports New Finding of Severity-Independent Efficacy in Treatment-Resistant DepressionGH Research PLC announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression (TRD): the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. The peer-reviewed article, titled “GH001 vs Placebo in Patients with Treatment-Resistant Depression” has been published in JAMA Psychiatry. The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form. A supporting peer-reviewed article, titled “GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial,” will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STARD trial (see About STARD below), represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001 does not follow this pattern: Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to =5 prior lifetime antidepressant failures, with no decline at higher failure counts; End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups; and No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Åsberg Depression Rating Scale (MADRS) improvement at Day 8 (r=-0.13; P=0.44) or among those who completed the 6-month OLE (r=-0.10; P=0.60). Consistent with the findings of this article, GH001 efficacy is also independent from prior treatment failures within the current depressive episode in this Phase 2b trial. Based on the observed clinical activity in our Phase 2b trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8.最新情報をもっと見るRecent updatesお知らせ • Jun 04GH Research PLC Publishes Full Results from Phase 2A Trial in Postpartum Depression and Announces Acceptance of Two Oral Presentations At CINP 2026GH Research PLC announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026). The peer-reviewed article, titled “Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial,” has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284). The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD. Primary endpoint met: Mean Montgomery–Åsberg Depression Rating Scale (MADRS) reduction of -35.4 points from baseline to Day 8. 100% of patients (10/10) achieved remission (MADRS total score =10) within two hours of dosing, sustained through Day 8. Improved maternal functioning: Mean 34.1-point (56%) increase on the Barkin Index of Maternal Functioning at Day 8. Well-tolerated: No serious adverse events; all treatment-emergent adverse events mild or moderate; no treatment-emergent suicidal ideation or behavior. An analysis of breast milk supports a treatment strategy with only a brief interruption of breastfeeding around GH001 dosing. The Company also announced that two featured communications have been accepted for oral presentation at CINP 2026, to be held June 26–29, 2026 in Glasgow, United Kingdom. Both present data from the Phase 2b GH001-TRD-201 trial of GH001 in treatment-resistant depression (TRD).Board Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 1 highly experienced director. Independent Non-Executive Director Dermot Hanley was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • May 14+ 1 more updateGH Research PLC, Annual General Meeting, Jun 25, 2026GH Research PLC, Annual General Meeting, Jun 25, 2026. Location: joshua dawson house, dawson street, dublin 2, d02 ry95., Irelandお知らせ • May 01GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18 Discount Per Security: $0.9お知らせ • Apr 29GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18お知らせ • Mar 25GH Research plc Announces Publication of Phase 2B Results for Mebufotenin (Gh001) in Jama Psychiatry and Reports New Finding of Severity-Independent Efficacy in Treatment-Resistant DepressionGH Research PLC announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression (TRD): the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. The peer-reviewed article, titled “GH001 vs Placebo in Patients with Treatment-Resistant Depression” has been published in JAMA Psychiatry. The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form. A supporting peer-reviewed article, titled “GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial,” will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STARD trial (see About STARD below), represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001 does not follow this pattern: Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to =5 prior lifetime antidepressant failures, with no decline at higher failure counts; End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups; and No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Åsberg Depression Rating Scale (MADRS) improvement at Day 8 (r=-0.13; P=0.44) or among those who completed the 6-month OLE (r=-0.10; P=0.60). Consistent with the findings of this article, GH001 efficacy is also independent from prior treatment failures within the current depressive episode in this Phase 2b trial. Based on the observed clinical activity in our Phase 2b trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8.お知らせ • Jan 05Gh Research plc Announces Fda Lifts Clinical Hold on Gh001, Clearing Path for Global Phase 3 Initiation in 2026GH Research PLC announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for GH001, enabling U.S. subject enrollment and advancing alignment of the company’s development efforts across major jurisdictions. The decision follows previously reported Phase 2b trial results (GH001-TRD-201), in which GH001 met its primary endpoint with a 15.5-point placebo-adjusted reduction in MADRS score on Day 8 (p<0.0001), demonstrated ultra-rapid remission in 57.5% of patients by Day 8 and 73% remission at six months with infrequent dosing averaging approximately four treatments, showed a short psychoactive experience with a median duration of about 11 minutes, required no psychotherapy, enabled 99% of patients to be discharge-ready within one hour of dosing, and exhibited a favorable safety profile with good tolerability and no serious treatment-related adverse events. Recent presentations at scientific conferences further support GH001’s potential integration into existing interventional psychiatry practices due to its convenient administration profile.お知らせ • Oct 17GH Research PLC Announces the Acceptance of Posters Related to its GH001-TRD-201 Clinical Trial at the 64 American College of Neuropsychopharmacology Annual MeetingGH Research PLC announced the acceptance of posters related to its GH001-TRD-201 clinical trial at the 64 American College of Neuropsychopharmacology (ACNP) annual meeting (the Congress), which is scheduled to take place from January 12-15, 2026, in Nassau, Bahamas. Over the 6-month duration of the trial, lower rates of Suicidal ideation compared to baseline were observed at each timepoint assessed with no treatment- emergent events of suicidal intent or suicidal behavior. At 99.0% (285/288) of treatment visits, patients were considered to be discharge ready at 1-hour post-dose on the dosing day. Results from a Phase 2a Clinical Trial: Results from a Phase 2a clinical trial. Over the 6-month period of the trial, lower rates the rates ofsuicidal ideation compared to baseline are observed at each timepoint assessed With GH001. At 99.0% ("285/288") of treatment visits, patients were thought to be discharge ready at 1 -hour post-dose on the Dosing day. Results from a phase 2a clinical trial. Results from a Phase 2 a clinical trial.お知らせ • Oct 10GH Research Announces Novel Therapies Symposium Presentation and Posters at the 2025 ECNP CongressGH Research PLC announced the acceptance of a Novel Therapies Symposium Presentation at the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands from October 11 - 14, where Professor Wieslaw J. Cubala, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdansk, will present long-term clinical data on the safety and efficacy from the open label extension (OLE) of a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201). Additionally, two posters have been accepted presenting safety and tolerability data from the open-label extension part of GH001-TRD-201 as well as data on the psychoactive effects of GH001 in patients with TRD from GH001- TRD-201.お知らせ • Jul 23GH Research plc Announces Global Pivotal Program Plans and Further Development UpdatesGH Research PLC provided updates on its business and key upcoming milestones. The company recently announced that the company submitted a complete response to the previously announced clinical hold on the Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA). The company have now received a response from the FDA with only one hold topic remaining. The FDA requested that either provide additional data or further justification related to the previously announced respiratory tract histology findings in rats. The company strongly believe, based on scientific evidence, that the respiratory tract histology findings are rat specific. There are no additional requests related to dog toxicology. There are no device related issues remaining. Engagement with FDA on IND complete response is ongoing. The company is actively working to address the remaining issue. Previously reported on the initial results from the phase 2b clinical trial of GH001 in treatment-resistant depression (TRD). This included part of the open-label extension (OLE) phase. The company can report on the full dataset. The primary endpoint was met with a highly significant placebo adjusted reduction from baseline of -15.5 points in Montgomery-Asberg Depression Rating Scale (MADRS) total score on Day 8 (p on that basis, The company expects to initiate global pivotal program in 2026.お知らせ • Jun 20Gh Research Submits Complete Ind Hold Response to FDA Ahead of ScheduleGH Research PLC announced that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application (IND) for GH001 to the U.S. Food and Drug Administration (FDA).お知らせ • Jun 19GH Research PLC, Annual General Meeting, Jul 31, 2025GH Research PLC, Annual General Meeting, Jul 31, 2025. Location: joshua dawson house, dawson street, dublin 2, d02 ry95, Irelandお知らせ • Feb 06GH Research PLC has completed a Follow-on Equity Offering in the amount of $150 million.GH Research PLC has completed a Follow-on Equity Offering in the amount of $150 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 10,000,000 Price\Range: $15 Discount Per Security: $0.9お知らせ • Feb 04+ 1 more updateGH Research PLC has filed a Follow-on Equity Offering in the amount of $150 million.GH Research PLC has filed a Follow-on Equity Offering in the amount of $150 million. Security Name: Ordinary Shares Security Type: Common Stockお知らせ • Jan 11GH Research PLC Provides Updates on Its Business and Highlighted Key Upcoming MilestonesGH Research PLC provided updates on its business and highlighted key upcoming milestones. The primary endpoint of the Phase 2a proof-of-concept (POC) trial for GH001 in postpartum depression (PPD) was met with a significant reduction from baseline of 35.4 points (96.3%) in Montgomery sberg Depression Rating Scale (MADRS) total score on Day 8 after administration of GH001 (p<0.0001). On Day 8, 100% of patients were in remission (MADRS 10). GH001 led to an ultra-rapid antidepressant effect with a significant reduction in MADRS score at 2 hours after administration of 31.4 points (p<0.0001) and on Day 2 of 36.0 points (p<0.0001). The trial recruited 10 patients with PPD. All patients were administered an individualized dosing regimen (IDR) of up to three escalating doses of GH001. There was no psychotherapeutic intervention in this trial. The mean total MADRS score on Day 8 was 1.3 and all 10 patients were in remission. GH001 was well tolerated and no treatment-related serious adverse events were reported. All treatment-emergent adverse events (TEAEs) were mild or moderate. The primary endpoint of the Phase 2a POC trial for GH001 in bipolar II disorder with a current major depressive episode (BDII) was met with a significant reduction from baseline of 16.8 points (51.9%) in MADRS total score on Day 8 after administration of GH001 (p=0.0099). On Day 8, 33.3% of patients were in remission (MADRS 10). GH001 led to an ultra-rapid antidepressant effect with a reduction in MADRS score at 2 hours after administration of 16.3 points (p=0.0006) and on Day 2 of -13.3 points (p=0.0299). The trial recruited 6 patients with BDII. All patients were administered an IDR of up to three escalating doses of GH001. There was no psychotherapeutic intervention in this trial. GH001 was well tolerated and no treatment-related serious adverse events were reported. The majority of TEAEs were mild or moderate and there were no reported TEAEs of hypomania or mania. Update on IND for GH001 As previously announced, Investigational New Drug Application (IND) for GH001 administered using proprietary aerosol delivery device has been placed on clinical hold by the U.S. Food and Drug Administration (FDA), with the FDA requesting that the company provide (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to investigator brochure, to resolve the hold. The requested additional inhalation toxicology study in a non-rodent species has now been completed. The pathology report concludes that there are no histology findings in the respiratory tract of any dogs at any dose level evaluated in the study. Based on previously announced FDA interactions, the response to their request for additional device design verification information is being prepared and, together with the completion of the inhalation toxicology studies, provides the final piece of information requested by the agency. This trial also includes a 6-month open-label extension which is on track for completion of last patient visit in the first quarter of 2025.Board Change • Oct 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. Independent Non-Executive Director Dermot Hanley was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Sep 03GH Research PLC Announces Chief Executive Officer ChangesGH Research PLC announced the promotion of Dr. Velichka “Villy” Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research. Dr. Valcheva has more than 20 years of experience in various leadership roles in the pharmaceutical and biotech industries. Dr. Valcheva joined the company in August 2023 and has served as the Company’s Chief Medical Officer since February 2024 having leadership responsibility, among other things, for the execution of the Company’s clinical development programs. She joined from Albireo, where, in her position as VP and Head of Medical Affairs International, she played a pivotal role in the company’s late-stage development, scientific communication, regulatory approvals by the U.S. Food and Drug Administration and EMA as well as gaining market access in multiple markets of the rare disease medicine Bylvay. Dr. Valcheva holds a Masters in Pharmaceutical Medicine from Trinity College Dublin, Ireland as well as a Dr. Med. from University of Medicine – Plovdiv, Bulgaria.お知らせ • May 18GH Research PLC, Annual General Meeting, Jun 27, 2024GH Research PLC, Annual General Meeting, Jun 27, 2024. Location: joshua dawson house, dawson street dublin 2, d02 ry95, Irelandお知らせ • Oct 01GH Research PLC Provides Updates and Guidance on Its Clinical Development Program for GH001 in Treatment-Resistant DepressionGH Research PLC provided updates and guidance on its clinical development program for GH001, its proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, in treatment-resistant depression (TRD). Development Strategy: As previously announced, following successful completion of Phase 1/2 trial of GH001 in patients with TRD (GH001-TRD-102), company is recruiting for a European multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in patients with TRD (GH001-TRD-201), where GH001 is administered using an externally-sourced inhalation device. Separately, company submitted, in the third quarter of 2023, an Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA), with the purpose to initiate a Phase 1 healthy volunteer clinical pharmacology trial, where GH001 is administered using proprietary aerosol delivery device (GH001-HV-106). The trial, subject to regulatory clearance from the FDA, is designed to support bridging to the clinical data generated with the externally-sourced inhalation device company currently use in European Phase 2b trial such that company can initiate, subject to data and regulatory clearance, a subsequent global Phase 3 pivotal program using proprietary device. Update and Guidance on European Phase 2b Clinical Trial of GH001 in Patients with TRD: Company multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in patients with TRD (GH001-TRD-201) is now approved in seven European countries and is expected to recruit approximately 80 patients across approximately 20 sites. The primary objective of the trial is to determine the efficacy of single-day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase. The double-blind phase is followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status. With 14 sites initiated and additional site initiations scheduled, Company is now in a position to provide guidance on completion of the double-blind phase of this trial, which is expected to occur in the third quarter of 2024, with top-line data available in the third or the fourth quarter of 2024. Update on IND for GH001: The Company recently submitted an IND for GH001 with the FDA. At the end of the 30-day review period, the FDA advised that it had placed IND on clinical hold due to “21 CFR 312.42(b)(1)(iv): Insufficient information to assess risks to human subjects”. The FDA indicated that a letter with additional details will be issued within 30 days.お知らせ • Jul 22GH Research PLC, Annual General Meeting, Aug 31, 2023GH Research PLC, Annual General Meeting, Aug 31, 2023, at 09:00 US Eastern Standard Time. Location: Joshua Dawson House Dawson Street Dublin 2 Co. Dublin Ireland Agenda: To re-elect, by separate resolutions, the individuals who retire as directors in accordance with the Constitution of the Company and, being eligible, offer themselves for re-election; to ratify the appointment of PricewaterhouseCoopers Ireland as independent auditors of the Company for the year ending 31 December 2023 and to authorize the Board to fix the remuneration of the auditors; to review the affairs of the Company and consider the Irish statutory financial statements for the year ended 31 December 2022 and the reports of the directors and auditors thereon; and to transact such other business as may properly come before the AGM or any adjournment or postponement thereof.お知らせ • May 26Gh Research plc Announces Accepted for Publication in Frontiers in PsychiatryOn May 23, 2023, GH Research PLC announced a manuscript titled "A Phase 1/2 Trial to Assess Safety and Efficacy of a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation (GH001) in Patients with Treatment-Resistant Depression" was accepted for publication in Frontiers in Psychiatry. The manuscript describes the results of completed phase 1/2 clinical trial in patients with treatment-resistant depression (GH001-TRD-102, NCT04698603). The abstract is available on the publisher's website. The final, formatted version of the manuscript will be published in due course.Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Vice Chairman Michael Forer was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • Aug 12GH Research PLC, Annual General Meeting, Sep 22, 2022GH Research PLC, Annual General Meeting, Sep 22, 2022, at 13:00 Coordinated Universal Time. Location: 3 Dublin Landings North Wall Quay Dublin 1, Ireland Dublin Co. Dublin Ireland Agenda: To re-elect, by separate resolutions, the following individuals who retire as directors in accordance with the constitution of the Company and, being eligible, offer themselves for re-election: To review the affairs of the Company and consider the Irish statutory financial statements for the year ended 31 December, 2021, and the reports of the directors and auditors thereon; To ratify the appointment of PricewaterhouseCoopers Ireland as independent auditors of the Company for the year ending 31 December, 2022, and to authorise the Board to fix the remuneration of the auditors.Board Change • Apr 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Vice Chairman Michael Forer was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.Board Change • Jul 28Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Non-Executive Director Michael Forer was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.株主還元1KADE PharmaceuticalsDE 市場7D6.4%5.5%3.8%1Y88.6%55.2%3.9%株主還元を見る業界別リターン: 1KA過去 1 年間で55.2 % の収益を上げたGerman Pharmaceuticals業界を上回りました。リターン対市場: 1KA過去 1 年間で3.9 % の収益を上げたGerman市場を上回りました。価格変動Is 1KA's price volatile compared to industry and market?1KA volatility1KA Average Weekly Movement13.5%Pharmaceuticals Industry Average Movement5.6%Market Average Movement5.6%10% most volatile stocks in DE Market12.5%10% least volatile stocks in DE Market2.7%安定した株価: 1KAの株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 1KAの weekly volatility ( 14% ) は過去 1 年間安定していますが、依然としてGermanの株式の 75% よりも高くなっています。会社概要設立従業員CEO（最高経営責任者ウェブサイト201873Villy Valchevawww.ghres.comGHリサーチPLCは、臨床段階のバイオ医薬品会社である子会社とともに、米国でうつ病の治療法の開発に取り組んでいる。同社の主要製品候補は、吸入可能なメブフォテニン製品候補であるGH001で、治療抵抗性うつ病患者を対象とした第2b相臨床試験中であり、双極II型障害と現在の大うつ病エピソード、および産後うつ病の女性患者を対象とした第2a相臨床試験中である。同社はまた、メブホテニン静注用製品候補であるGH002を開発しており、精神疾患および神経疾患に焦点を当てた健康なボランティアを対象とした第1相臨床薬理試験中である。同社は2018年に設立され、アイルランドのダブリンに拠点を置いている。もっと見るGH Research PLC 基礎のまとめGH Research の収益と売上を時価総額と比較するとどうか。1KA 基礎統計学時価総額€1.62b収益（TTM）-€49.32m売上高(TTM)n/a0.0xP/Sレシオ-32.8xPER（株価収益率1KA は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計1KA 損益計算書（TTM）収益US$0売上原価US$0売上総利益US$0その他の費用US$56.41m収益-US$56.41m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-0.82グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0%1KA の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/03 09:23終値2026/07/03 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社の Github ページ でご覧いただけます。また、レポートの使い方に関する ガイド や YouTube の チュートリアル もご用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋GH Research PLC 9 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。11 アナリスト機関Sumant Satchidanand KulkarniCanaccord GenuityCharles DuncanCantor Fitzgerald & Co.Joshua SchimmerCantor Fitzgerald & Co.8 その他のアナリストを表示
お知らせ • Jun 04GH Research PLC Publishes Full Results from Phase 2A Trial in Postpartum Depression and Announces Acceptance of Two Oral Presentations At CINP 2026GH Research PLC announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026). The peer-reviewed article, titled “Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial,” has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284). The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD. Primary endpoint met: Mean Montgomery–Åsberg Depression Rating Scale (MADRS) reduction of -35.4 points from baseline to Day 8. 100% of patients (10/10) achieved remission (MADRS total score =10) within two hours of dosing, sustained through Day 8. Improved maternal functioning: Mean 34.1-point (56%) increase on the Barkin Index of Maternal Functioning at Day 8. Well-tolerated: No serious adverse events; all treatment-emergent adverse events mild or moderate; no treatment-emergent suicidal ideation or behavior. An analysis of breast milk supports a treatment strategy with only a brief interruption of breastfeeding around GH001 dosing. The Company also announced that two featured communications have been accepted for oral presentation at CINP 2026, to be held June 26–29, 2026 in Glasgow, United Kingdom. Both present data from the Phase 2b GH001-TRD-201 trial of GH001 in treatment-resistant depression (TRD).
Board Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 1 highly experienced director. Independent Non-Executive Director Dermot Hanley was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • May 14+ 1 more updateGH Research PLC, Annual General Meeting, Jun 25, 2026GH Research PLC, Annual General Meeting, Jun 25, 2026. Location: joshua dawson house, dawson street, dublin 2, d02 ry95., Ireland
お知らせ • May 01GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18 Discount Per Security: $0.9
お知らせ • Apr 29GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18
お知らせ • Mar 25GH Research plc Announces Publication of Phase 2B Results for Mebufotenin (Gh001) in Jama Psychiatry and Reports New Finding of Severity-Independent Efficacy in Treatment-Resistant DepressionGH Research PLC announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression (TRD): the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. The peer-reviewed article, titled “GH001 vs Placebo in Patients with Treatment-Resistant Depression” has been published in JAMA Psychiatry. The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form. A supporting peer-reviewed article, titled “GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial,” will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STARD trial (see About STARD below), represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001 does not follow this pattern: Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to =5 prior lifetime antidepressant failures, with no decline at higher failure counts; End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups; and No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Åsberg Depression Rating Scale (MADRS) improvement at Day 8 (r=-0.13; P=0.44) or among those who completed the 6-month OLE (r=-0.10; P=0.60). Consistent with the findings of this article, GH001 efficacy is also independent from prior treatment failures within the current depressive episode in this Phase 2b trial. Based on the observed clinical activity in our Phase 2b trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8.
お知らせ • Jun 04GH Research PLC Publishes Full Results from Phase 2A Trial in Postpartum Depression and Announces Acceptance of Two Oral Presentations At CINP 2026GH Research PLC announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026). The peer-reviewed article, titled “Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial,” has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284). The article reports the full results from the Phase 2a, single-arm, open-label trial, which enrolled 10 adult women with PPD. Primary endpoint met: Mean Montgomery–Åsberg Depression Rating Scale (MADRS) reduction of -35.4 points from baseline to Day 8. 100% of patients (10/10) achieved remission (MADRS total score =10) within two hours of dosing, sustained through Day 8. Improved maternal functioning: Mean 34.1-point (56%) increase on the Barkin Index of Maternal Functioning at Day 8. Well-tolerated: No serious adverse events; all treatment-emergent adverse events mild or moderate; no treatment-emergent suicidal ideation or behavior. An analysis of breast milk supports a treatment strategy with only a brief interruption of breastfeeding around GH001 dosing. The Company also announced that two featured communications have been accepted for oral presentation at CINP 2026, to be held June 26–29, 2026 in Glasgow, United Kingdom. Both present data from the Phase 2b GH001-TRD-201 trial of GH001 in treatment-resistant depression (TRD).
Board Change • May 20Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 3 experienced directors. 1 highly experienced director. Independent Non-Executive Director Dermot Hanley was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • May 14+ 1 more updateGH Research PLC, Annual General Meeting, Jun 25, 2026GH Research PLC, Annual General Meeting, Jun 25, 2026. Location: joshua dawson house, dawson street, dublin 2, d02 ry95., Ireland
お知らせ • May 01GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has completed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18 Discount Per Security: $0.9
お知らせ • Apr 29GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million.GH Research PLC has filed a Follow-on Equity Offering in the amount of $117.500022 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 6,527,779 Price\Range: $18
お知らせ • Mar 25GH Research plc Announces Publication of Phase 2B Results for Mebufotenin (Gh001) in Jama Psychiatry and Reports New Finding of Severity-Independent Efficacy in Treatment-Resistant DepressionGH Research PLC announced two peer-reviewed publications from its Phase 2b clinical program of GH001 in treatment-resistant depression (TRD): the primary trial results in JAMA Psychiatry, and a new analysis demonstrating that efficacy is independent of the number of prior lifetime treatment failures in a forthcoming issue of Psychopharmacology Bulletin. The peer-reviewed article, titled “GH001 vs Placebo in Patients with Treatment-Resistant Depression” has been published in JAMA Psychiatry. The publication includes the complete results from the randomized, double-blind, placebo-controlled Phase 2b trial of mebufotenin in patients with TRD, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from the 6-month open-label extension. These results were previously reported in topline form. A supporting peer-reviewed article, titled “GH001 Efficacy is Independent of Prior Antidepressant Treatment Failures in Treatment-Resistant Depression: A Post Hoc Analysis of a Phase 2b Randomized Controlled Trial,” will be published in a forthcoming issue of Psychopharmacology Bulletin. In TRD, a well-established finding across multiple treatment modalities is that remission rates decline significantly with each successive antidepressant treatment failure. This pattern, first quantified in the landmark STARD trial (see About STARD below), represents a fundamental challenge in treating patients with extensive treatment histories. The new analysis of Phase 2b data demonstrates that GH001 does not follow this pattern: Day 8 remission rates ranged from 53.9% to 63.6% across patients with 2 to =5 prior lifetime antidepressant failures, with no decline at higher failure counts; End of trial/Month 6 remission rates ranged from 61.5% to 85.7% across the same subgroups; and No meaningful correlation was observed between the number of prior lifetime treatment failures and Montgomery-Åsberg Depression Rating Scale (MADRS) improvement at Day 8 (r=-0.13; P=0.44) or among those who completed the 6-month OLE (r=-0.10; P=0.60). Consistent with the findings of this article, GH001 efficacy is also independent from prior treatment failures within the current depressive episode in this Phase 2b trial. Based on the observed clinical activity in our Phase 2b trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8.
お知らせ • Jan 05Gh Research plc Announces Fda Lifts Clinical Hold on Gh001, Clearing Path for Global Phase 3 Initiation in 2026GH Research PLC announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug (IND) application for GH001, enabling U.S. subject enrollment and advancing alignment of the company’s development efforts across major jurisdictions. The decision follows previously reported Phase 2b trial results (GH001-TRD-201), in which GH001 met its primary endpoint with a 15.5-point placebo-adjusted reduction in MADRS score on Day 8 (p<0.0001), demonstrated ultra-rapid remission in 57.5% of patients by Day 8 and 73% remission at six months with infrequent dosing averaging approximately four treatments, showed a short psychoactive experience with a median duration of about 11 minutes, required no psychotherapy, enabled 99% of patients to be discharge-ready within one hour of dosing, and exhibited a favorable safety profile with good tolerability and no serious treatment-related adverse events. Recent presentations at scientific conferences further support GH001’s potential integration into existing interventional psychiatry practices due to its convenient administration profile.
お知らせ • Oct 17GH Research PLC Announces the Acceptance of Posters Related to its GH001-TRD-201 Clinical Trial at the 64 American College of Neuropsychopharmacology Annual MeetingGH Research PLC announced the acceptance of posters related to its GH001-TRD-201 clinical trial at the 64 American College of Neuropsychopharmacology (ACNP) annual meeting (the Congress), which is scheduled to take place from January 12-15, 2026, in Nassau, Bahamas. Over the 6-month duration of the trial, lower rates of Suicidal ideation compared to baseline were observed at each timepoint assessed with no treatment- emergent events of suicidal intent or suicidal behavior. At 99.0% (285/288) of treatment visits, patients were considered to be discharge ready at 1-hour post-dose on the dosing day. Results from a Phase 2a Clinical Trial: Results from a Phase 2a clinical trial. Over the 6-month period of the trial, lower rates the rates ofsuicidal ideation compared to baseline are observed at each timepoint assessed With GH001. At 99.0% ("285/288") of treatment visits, patients were thought to be discharge ready at 1 -hour post-dose on the Dosing day. Results from a phase 2a clinical trial. Results from a Phase 2 a clinical trial.
お知らせ • Oct 10GH Research Announces Novel Therapies Symposium Presentation and Posters at the 2025 ECNP CongressGH Research PLC announced the acceptance of a Novel Therapies Symposium Presentation at the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands from October 11 - 14, where Professor Wieslaw J. Cubala, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdansk, will present long-term clinical data on the safety and efficacy from the open label extension (OLE) of a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201). Additionally, two posters have been accepted presenting safety and tolerability data from the open-label extension part of GH001-TRD-201 as well as data on the psychoactive effects of GH001 in patients with TRD from GH001- TRD-201.
お知らせ • Jul 23GH Research plc Announces Global Pivotal Program Plans and Further Development UpdatesGH Research PLC provided updates on its business and key upcoming milestones. The company recently announced that the company submitted a complete response to the previously announced clinical hold on the Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA). The company have now received a response from the FDA with only one hold topic remaining. The FDA requested that either provide additional data or further justification related to the previously announced respiratory tract histology findings in rats. The company strongly believe, based on scientific evidence, that the respiratory tract histology findings are rat specific. There are no additional requests related to dog toxicology. There are no device related issues remaining. Engagement with FDA on IND complete response is ongoing. The company is actively working to address the remaining issue. Previously reported on the initial results from the phase 2b clinical trial of GH001 in treatment-resistant depression (TRD). This included part of the open-label extension (OLE) phase. The company can report on the full dataset. The primary endpoint was met with a highly significant placebo adjusted reduction from baseline of -15.5 points in Montgomery-Asberg Depression Rating Scale (MADRS) total score on Day 8 (p on that basis, The company expects to initiate global pivotal program in 2026.
お知らせ • Jun 20Gh Research Submits Complete Ind Hold Response to FDA Ahead of ScheduleGH Research PLC announced that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application (IND) for GH001 to the U.S. Food and Drug Administration (FDA).
お知らせ • Jun 19GH Research PLC, Annual General Meeting, Jul 31, 2025GH Research PLC, Annual General Meeting, Jul 31, 2025. Location: joshua dawson house, dawson street, dublin 2, d02 ry95, Ireland
お知らせ • Feb 06GH Research PLC has completed a Follow-on Equity Offering in the amount of $150 million.GH Research PLC has completed a Follow-on Equity Offering in the amount of $150 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 10,000,000 Price\Range: $15 Discount Per Security: $0.9
お知らせ • Feb 04+ 1 more updateGH Research PLC has filed a Follow-on Equity Offering in the amount of $150 million.GH Research PLC has filed a Follow-on Equity Offering in the amount of $150 million. Security Name: Ordinary Shares Security Type: Common Stock
お知らせ • Jan 11GH Research PLC Provides Updates on Its Business and Highlighted Key Upcoming MilestonesGH Research PLC provided updates on its business and highlighted key upcoming milestones. The primary endpoint of the Phase 2a proof-of-concept (POC) trial for GH001 in postpartum depression (PPD) was met with a significant reduction from baseline of 35.4 points (96.3%) in Montgomery sberg Depression Rating Scale (MADRS) total score on Day 8 after administration of GH001 (p<0.0001). On Day 8, 100% of patients were in remission (MADRS 10). GH001 led to an ultra-rapid antidepressant effect with a significant reduction in MADRS score at 2 hours after administration of 31.4 points (p<0.0001) and on Day 2 of 36.0 points (p<0.0001). The trial recruited 10 patients with PPD. All patients were administered an individualized dosing regimen (IDR) of up to three escalating doses of GH001. There was no psychotherapeutic intervention in this trial. The mean total MADRS score on Day 8 was 1.3 and all 10 patients were in remission. GH001 was well tolerated and no treatment-related serious adverse events were reported. All treatment-emergent adverse events (TEAEs) were mild or moderate. The primary endpoint of the Phase 2a POC trial for GH001 in bipolar II disorder with a current major depressive episode (BDII) was met with a significant reduction from baseline of 16.8 points (51.9%) in MADRS total score on Day 8 after administration of GH001 (p=0.0099). On Day 8, 33.3% of patients were in remission (MADRS 10). GH001 led to an ultra-rapid antidepressant effect with a reduction in MADRS score at 2 hours after administration of 16.3 points (p=0.0006) and on Day 2 of -13.3 points (p=0.0299). The trial recruited 6 patients with BDII. All patients were administered an IDR of up to three escalating doses of GH001. There was no psychotherapeutic intervention in this trial. GH001 was well tolerated and no treatment-related serious adverse events were reported. The majority of TEAEs were mild or moderate and there were no reported TEAEs of hypomania or mania. Update on IND for GH001 As previously announced, Investigational New Drug Application (IND) for GH001 administered using proprietary aerosol delivery device has been placed on clinical hold by the U.S. Food and Drug Administration (FDA), with the FDA requesting that the company provide (i) an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study in rats, (ii) additional device design verification information and (iii) updates to investigator brochure, to resolve the hold. The requested additional inhalation toxicology study in a non-rodent species has now been completed. The pathology report concludes that there are no histology findings in the respiratory tract of any dogs at any dose level evaluated in the study. Based on previously announced FDA interactions, the response to their request for additional device design verification information is being prepared and, together with the completion of the inhalation toxicology studies, provides the final piece of information requested by the agency. This trial also includes a 6-month open-label extension which is on track for completion of last patient visit in the first quarter of 2025.
Board Change • Oct 01Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. No highly experienced directors. Independent Non-Executive Director Dermot Hanley was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Sep 03GH Research PLC Announces Chief Executive Officer ChangesGH Research PLC announced the promotion of Dr. Velichka “Villy” Valcheva, MD, MSc. to Chief Executive Officer of the Company. Dr. Valcheva succeeds PD Dr. med. Theis Terwey, co-founder of GH Research. Dr. Valcheva has more than 20 years of experience in various leadership roles in the pharmaceutical and biotech industries. Dr. Valcheva joined the company in August 2023 and has served as the Company’s Chief Medical Officer since February 2024 having leadership responsibility, among other things, for the execution of the Company’s clinical development programs. She joined from Albireo, where, in her position as VP and Head of Medical Affairs International, she played a pivotal role in the company’s late-stage development, scientific communication, regulatory approvals by the U.S. Food and Drug Administration and EMA as well as gaining market access in multiple markets of the rare disease medicine Bylvay. Dr. Valcheva holds a Masters in Pharmaceutical Medicine from Trinity College Dublin, Ireland as well as a Dr. Med. from University of Medicine – Plovdiv, Bulgaria.
お知らせ • May 18GH Research PLC, Annual General Meeting, Jun 27, 2024GH Research PLC, Annual General Meeting, Jun 27, 2024. Location: joshua dawson house, dawson street dublin 2, d02 ry95, Ireland
お知らせ • Oct 01GH Research PLC Provides Updates and Guidance on Its Clinical Development Program for GH001 in Treatment-Resistant DepressionGH Research PLC provided updates and guidance on its clinical development program for GH001, its proprietary inhalable mebufotenin (5-MeO-DMT) product candidate, in treatment-resistant depression (TRD). Development Strategy: As previously announced, following successful completion of Phase 1/2 trial of GH001 in patients with TRD (GH001-TRD-102), company is recruiting for a European multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in patients with TRD (GH001-TRD-201), where GH001 is administered using an externally-sourced inhalation device. Separately, company submitted, in the third quarter of 2023, an Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA), with the purpose to initiate a Phase 1 healthy volunteer clinical pharmacology trial, where GH001 is administered using proprietary aerosol delivery device (GH001-HV-106). The trial, subject to regulatory clearance from the FDA, is designed to support bridging to the clinical data generated with the externally-sourced inhalation device company currently use in European Phase 2b trial such that company can initiate, subject to data and regulatory clearance, a subsequent global Phase 3 pivotal program using proprietary device. Update and Guidance on European Phase 2b Clinical Trial of GH001 in Patients with TRD: Company multi-center, randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in patients with TRD (GH001-TRD-201) is now approved in seven European countries and is expected to recruit approximately 80 patients across approximately 20 sites. The primary objective of the trial is to determine the efficacy of single-day individualized dosing regimen (IDR) of GH001 compared with placebo in improving depressive symptoms as assessed by the mean change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) at the end of the 7-day double-blind phase. The double-blind phase is followed by a 6-month open-label extension phase where all patients can receive treatment with the GH001 IDR as-needed, based on the patient’s clinical status. With 14 sites initiated and additional site initiations scheduled, Company is now in a position to provide guidance on completion of the double-blind phase of this trial, which is expected to occur in the third quarter of 2024, with top-line data available in the third or the fourth quarter of 2024. Update on IND for GH001: The Company recently submitted an IND for GH001 with the FDA. At the end of the 30-day review period, the FDA advised that it had placed IND on clinical hold due to “21 CFR 312.42(b)(1)(iv): Insufficient information to assess risks to human subjects”. The FDA indicated that a letter with additional details will be issued within 30 days.
お知らせ • Jul 22GH Research PLC, Annual General Meeting, Aug 31, 2023GH Research PLC, Annual General Meeting, Aug 31, 2023, at 09:00 US Eastern Standard Time. Location: Joshua Dawson House Dawson Street Dublin 2 Co. Dublin Ireland Agenda: To re-elect, by separate resolutions, the individuals who retire as directors in accordance with the Constitution of the Company and, being eligible, offer themselves for re-election; to ratify the appointment of PricewaterhouseCoopers Ireland as independent auditors of the Company for the year ending 31 December 2023 and to authorize the Board to fix the remuneration of the auditors; to review the affairs of the Company and consider the Irish statutory financial statements for the year ended 31 December 2022 and the reports of the directors and auditors thereon; and to transact such other business as may properly come before the AGM or any adjournment or postponement thereof.
お知らせ • May 26Gh Research plc Announces Accepted for Publication in Frontiers in PsychiatryOn May 23, 2023, GH Research PLC announced a manuscript titled "A Phase 1/2 Trial to Assess Safety and Efficacy of a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation (GH001) in Patients with Treatment-Resistant Depression" was accepted for publication in Frontiers in Psychiatry. The manuscript describes the results of completed phase 1/2 clinical trial in patients with treatment-resistant depression (GH001-TRD-102, NCT04698603). The abstract is available on the publisher's website. The final, formatted version of the manuscript will be published in due course.
Board Change • Nov 16Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Vice Chairman Michael Forer was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • Aug 12GH Research PLC, Annual General Meeting, Sep 22, 2022GH Research PLC, Annual General Meeting, Sep 22, 2022, at 13:00 Coordinated Universal Time. Location: 3 Dublin Landings North Wall Quay Dublin 1, Ireland Dublin Co. Dublin Ireland Agenda: To re-elect, by separate resolutions, the following individuals who retire as directors in accordance with the constitution of the Company and, being eligible, offer themselves for re-election: To review the affairs of the Company and consider the Irish statutory financial statements for the year ended 31 December, 2021, and the reports of the directors and auditors thereon; To ratify the appointment of PricewaterhouseCoopers Ireland as independent auditors of the Company for the year ending 31 December, 2022, and to authorise the Board to fix the remuneration of the auditors.
Board Change • Apr 27Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Vice Chairman Michael Forer was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
Board Change • Jul 28Less than half of directors are independentFollowing the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 2 non-independent directors. Independent Non-Executive Director Michael Forer was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
