Notizie in diretta • May 24
GH Research Advances TRD Program With Positive Phase 2b Data and US$400 Million Shelf Approval GH Research reported positive Phase 2b results for its inhaled mebufotenin candidate GH001 in treatment-resistant depression, with Day 8 remission rates between 53.9% and 63.6% and benefits observed through a 6-month open-label extension.
The company has completed enrollment in two Phase 1 studies of its proprietary aerosol delivery device and selected doses for a planned global Phase 3 program, targeting trial initiation in late 2026 following FDA alignment.
GH Research’s Form F-3 shelf registration for up to US$400m of various securities became effective on May 19, 2026, providing flexibility to fund clinical development, pre-commercial work, and general corporate needs, alongside a reported cash position of US$267.3m as of March 31, 2026.
The combination of Phase 2b data publication in JAMA Psychiatry, progression toward a global Phase 3 program, and an effective US$400m shelf registration indicates a company preparing for more capital-intensive late-stage trials and potential pre-commercial activities.
For you as an investor, the key considerations are clinical and regulatory execution in TRD and the likelihood of future equity or other security offerings under the shelf that could affect your stake. Board Change • May 20
Insufficient new directors No 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. Annuncio • May 01
GH 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 Annuncio • Apr 29
GH 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 Annuncio • Mar 25
GH 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 Depression GH 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. Annuncio • Jan 05
Gh Research plc Announces Fda Lifts Clinical Hold on Gh001, Clearing Path for Global Phase 3 Initiation in 2026 GH 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. Annuncio • Oct 17
GH Research PLC Announces the Acceptance of Posters Related to its GH001-TRD-201 Clinical Trial at the 64 American College of Neuropsychopharmacology Annual Meeting GH 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. Annuncio • Oct 10
GH Research Announces Novel Therapies Symposium Presentation and Posters at the 2025 ECNP Congress GH 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. Annuncio • Jul 23
GH Research plc Announces Global Pivotal Program Plans and Further Development Updates GH 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. Annuncio • Jun 20
Gh Research Submits Complete Ind Hold Response to FDA Ahead of Schedule GH 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). Annuncio • Jun 19
GH Research PLC, Annual General Meeting, Jul 31, 2025 GH Research PLC, Annual General Meeting, Jul 31, 2025. Location: joshua dawson house, dawson street, dublin 2, d02 ry95, Ireland Annuncio • Feb 06
GH 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 Annuncio • Jan 11
GH Research PLC Provides Updates on Its Business and Highlighted Key Upcoming Milestones GH 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. Annuncio • Sep 03
GH Research PLC Announces Chief Executive Officer Changes GH 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. Annuncio • May 18
GH Research PLC, Annual General Meeting, Jun 27, 2024 GH Research PLC, Annual General Meeting, Jun 27, 2024. Location: joshua dawson house, dawson street dublin 2, d02 ry95, Ireland Price Target Changed • Mar 03
Price target decreased by 12% to US$31.75 Down from US$36.25, the current price target is an average from 4 analysts. New target price is 274% above last closing price of US$8.50. Stock is down 19% over the past year. The company is forecast to post a net loss per share of US$1.05 next year compared to a net loss per share of US$0.68 last year. Price Target Changed • Dec 18
Price target decreased by 11% to US$34.50 Down from US$38.75, the current price target is an average from 4 analysts. New target price is 556% above last closing price of US$5.26. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$0.67 next year compared to a net loss per share of US$0.43 last year. Annuncio • Oct 01
GH Research PLC Provides Updates and Guidance on Its Clinical Development Program for GH001 in Treatment-Resistant Depression GH 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. Annuncio • Jul 22
GH Research PLC, Annual General Meeting, Aug 31, 2023 GH 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. Annuncio • May 26
Gh Research plc Announces Accepted for Publication in Frontiers in Psychiatry On 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 16
Less than half of directors are independent Following 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 • Apr 27
Less than half of directors are independent Following 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. Annuncio • Jun 26
GH Research PLC has completed an IPO in the amount of $160 million. GH Research PLC has completed an IPO in the amount of $160 million.
Security Name: Ordinary shares
Security Type: Common Stock
Securities Offered: 10,000,000
Price\Range: $16