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GH Research PLC

$26.51

-0.69 (-2.54%)

D 32Pipeline Score Richly Valued Pharma · Clinical
Market Cap
1.52 B
EPS
-0.91
P/E Ratio
-
Value Trade
3.44 M
0.68 %
Week
4.64 %
1 Month
40 %
3 Month
57.77 %
6 Month
0.55 %
5 Year
0.55 %
All Time
Cash Data
  • Cash Position

    12.35 K

  • Monthly Burn

    12.35 K

  • Runway

    12,345 mo

Overview
Volume
128.46 K
52 Week Range
10.96 - 24.66
% held by Insiders
25.79 %
% held by Institutions
68.2 %
Enterprise Value
1.25 B
Total Shares
62.06 M
Short %
4.28 %
Float Shares
45.24 M
Company Description

locked

Upcoming Catalyst
Catalyst Drug/Treatment Stage Probability of Approval Description Drug Type Therapeutic Area Source
GH002 Treatment‑resistant depression and planned global pivotal development (IV formulation may support alternative administration routes/registrational trials)
Phase 3

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Small Molecules
Psychiatric Disorders
GH002 Treatment‑resistant depression and planned global pivotal development (IV formulation may support alternative administration routes/registrational trials)
Phase 3

Subscribe to access the data.

Small Molecules
Psychiatric Disorders
GH002 Treatment‑resistant depression and planned global pivotal development (IV formulation may support alternative administration routes/registrational trials)
Phase 3

Subscribe to access the data.

Small Molecules
Psychiatric Disorders
Unlock Upcoming Catalyst data

Catalyst Timeline

Dated clinical, regulatory & corporate events for GH Research PLC

145Total events
1Upcoming
40Tier-1 (high impact)
2021 – 2026Coverage

Upcoming catalysts 1

Q4 2026
T2Trial Initiation
Target initiation of global Phase 3 pivotal program in late 2026
GH001treatment-resistant depression (TRD)Phase 3

Event history 144

Jun 28, 2026
Oral PresentationGH001Presentation
Oral presentation of Phase 2b TRD safety results at CINP 2026
treatment-resistant depressionsource ↗
Jun 27, 2026
Oral PresentationGH001Presentation
Oral presentation of Phase 2b TRD efficacy results at CINP 2026
treatment-resistant depressionsource ↗
Jun 4, 2026
Full ResultsGH001Clinical Data
Publication of Phase 2a PPD full results in The Journal of Clinical Psychiatry
postpartum depressionsource ↗
May 26, 2026
Oral PresentationGH001Presentation
Post-hoc analysis of MADRS anhedonia factor presented at ASCP Annual Meeting
treatment-resistant depressionsource ↗
May 26, 2026
Poster PresentationGH001Presentation
Three posters accepted at ASCP Annual Meeting 2026
treatment-resistant depression (TRD) and bipolar II depressionsource ↗
May 14, 2026
Enrollment CompleteGH001Trial
GH001-HV-106 study enrolment completed
healthy volunteerssource ↗
May 14, 2026
Dose Finding UpdateGH001Trial
Doses selected for global Phase 3 pivotal program based on GH001-HV-106 results
treatment-resistant depression (TRD)source ↗
May 14, 2026
Quarterly UpdateCorporate
First quarter 2026 financial results reported
Apr 29, 2026
Equity OfferingCorporate
Pricing of $117.5 million underwritten offering of ordinary shares at $18.00 per share
Apr 2026
Equity OfferingCorporate
Underwritten offering completed in April 2026, net proceeds $111.2 million
Mar 25, 2026
Full ResultsGH001Clinical Data
Phase 2b results for GH001 in TRD published in JAMA Psychiatry
treatment-resistant depressionsource ↗
Mar 25, 2026
Topline ReadoutGH001Clinical Data
Primary endpoint met: MADRS total score reduction at Day 8
treatment-resistant depressionsource ↗
Drug Pipeline Intelligence
D32
Pipeline Score
$68M
Pipeline Value
Richly Valued
Valuation Signal
2
Drugs Scored
0.0x
rNPV / MCap
Top 40%
Micro Cap
(rank 548 of 911)
Percentile Rank
GH Research PLC faces pipeline headwinds (32/100), with $203M risk-adjusted pipeline value, led by GH001 in Treatment-resistant Depression (Phase 2).
Showing 1 of 1 assets
DrugIndicationPhaseNCT IDPTRSrNPVStatusEnrollmentVelocityDesignCompletionML SignalLast Change
GH001
Small molecule
Treatment-resistant DepressionPhase 2NCT0580086012% $133M COMPLETED 81 - -Mar 11, 2025 -May 31, 2025
Unlock Drug Pipeline Intelligence
Clinical Trial Results
Drug Name Indications Phase Date Trial Results Summary Title Source
GH001
postpartum depression
Phase 2a
2026-06-04

all 10 participants experienced rapid remission within hours of treatment, with effects lasting until Day 8 and a favorable safety profile

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GH Research Announces Publication of Phase 2a Postpartum Depression Results Dublin, Ireland

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GH001
postpartum depression
Phase 2a
2026-06-04

all 10 participants experienced rapid remission within hours of treatment, with effects lasting until Day 8 and a favorable safety profile

Read More

GH Research Announces Publication of Phase 2a Postpartum Depression Results Dublin, Ireland

Read More
GH001
postpartum depression
Phase 2a
2026-06-04

all 10 participants experienced rapid remission within hours of treatment, with effects lasting until Day 8 and a favorable safety profile

Read More

GH Research Announces Publication of Phase 2a Postpartum Depression Results Dublin, Ireland

Read More
Unlock Clinical Trial Results data
Inside Trades
TREND
CORPORATE INSIDERS BOUGHT SHARES WORTH 1.8M IN THE LAST 3 MONTHS
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLD
INSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Unlock Inside Trades data
Hedge Funds
TREND
HEDGE FUNDS INCREASED HOLDINGS BY 200.0K SHARES IN THE LAST QUARTER
Shares Held
2040.00B1530.00B1020.00B510.00B0
Q3
2024
Q4
2024
Q1
2025
Q2
2025
HEDGE FUNDS
SOLD
HEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Fund Count
60%
Share Volume
25%
Conviction
15%
HedgeFund Name
( 3 )
% of Portfolio Current MV
-
Shares Owned
-
Activity
Avg Price $0

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K

Example Capital Management

2.5 %
15.00 M
250.00 K
Unlock Hedge Funds table data
GHRS Institutional Ownership Trends
Current Insider %
5.20%
+0.00%
Current Institutional %
62.40%
+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
ExpirationVolumeOpen InterestImplied Volatility CallsImplied Volatility Puts
CallsPutsPut-Call RatioCallsPutsPut-Call RatioIVOiWaIvVWaIvIVOiWaIvVWaIv
2026-07-170 0.00 0 0 - - - - - -
2026-07-170 0.00 0 0 - - - - - -
2026-07-170 0.00 0 0 - - - - - -
Unlock Option Chain Statistics data
Option Chain
CallsStrikePuts
Last PriceVolumeOpen InterestLast PriceVolumeOpen Interest
No data available
Unlock Option Chain data
Unlock Options Chart data
Open interest
0 600K 1.2M 1.8M Avg OI 1.00 M Open Interest
0 1 2 3 1.1 Put-Call Ratio
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
0 450K 900K 1.4M Avg OV 750.00 K Option Volume
0 1 2 3 0.95 Put-Call Ratio
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
GHRS
Jun 4, 2026
GHRSPhases

GH Research Announces Publication of Phase 2a Postpartum Depression Results Dublin, Ireland

GH Research PLC announced the publication of results from its Phase 2a trial of inhaled mebufotenin for postpartum depression (PPD). The study showed that all 10 participants experienced rapid remission within hours of treatment, with effects lasting until Day 8 and a favorable safety profile. Additionally, the company has two oral presentations accepted for the upcoming World Congress of Neuropsychopharmacology, about ongoing trials related to treatment-resistant depression. These developments represent significant progress in the search for effective therapies for patients with PPD.

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GHRS
May 21, 2026
GHRSPhases

Apparent sadness Reported sadness Concentration difficulty Lassitude Inability to feel Mean (SD) Change from Baseline in MADRS Anhedonia Factor Items at Day 8 Results Disposition and Baseline Characteristics Disposition

GH Research's clinical trial evaluated GH001, a mebufotenin formulation, for efficacy in patients with treatment-resistant depression (TRD). The Phase 2b study showed significant improvements in the Montgomery- sberg Depression Rating Scale (MADRS) anhedonia factor scores, with rapid reductions observed at Day 8. Results indicated that GH001 not only enhanced the ability to experience pleasure but also had sustained effects through a subsequent open-label extension phase. Overall, the findings support GH001's potential to improve quality of life in TRD patients.

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GHRS
May 14, 2026
GHRSGeneral

GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive loss Three months ended

GH Research PLC reported its unaudited condensed consolidated interim financial results for the three months ended March 31, 2026. The company experienced a significant increase in losses, with a loss before tax of $18,967k, compared to $10,812k in the same period last year. Operating expenses surged, particularly in research and development, contributing to a comprehensive loss of $18,229k. The group's total assets decreased from $288,230k to $275,267k during the same timeframe, highlighting potential financial challenges.

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GHRS
May 14, 2026
GHRSFDA Updates

GH Research Reports First Quarter 2026 Financial Results and Provides Business Update

GH Research PLC reported its financial results for Q1 2026, highlighting significant progress in its clinical trials for GH001, a treatment for treatment-resistant depression (TRD). The company completed enrolment for several studies, including a Phase 3 pivotal program and a Phase 1 trial in the U.S. Financially, GHRS holds $267.3 million in cash but reported a net loss of $19 million for the quarter. Positive results from the Phase 2b trial were published, indicating potential efficacy for their lead product candidate.

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GHRS
May 13, 2026
GHRSGeneral

Notice of Annual General Meeting to be held on 25 June 2026 GH Research plc (the Company or GH Research ) THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt as to the action to be t

GH Research plc has announced its Annual General Meeting (AGM) to take place on June 25, 2026, in Dublin, Ireland. The meeting will focus on the re-election of board directors and the appointment of independent auditors. Shareholders will have the opportunity to review the audited financial statements from 2025. The board recommends that shareholders vote in favor of the proposed resolutions, emphasizing the commitment of the directors to the company's interests.

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GHRS
Apr 29, 2026
GHRSGeneral

GH Research Announces Pricing of $117.5 Million Underwritten Offering

GH Research PLC has announced the pricing of an underwritten offering of 6,527,779 ordinary shares at $18.00 per share, aiming to raise approximately $117.5 million. The offering is set to close on April 30, 2026, and is managed by several financial institutions. The proceeds will support the company's efforts in developing treatments for depression.

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GHRS
Apr 20, 2026
GHRSFDA Updates
▲ +17.2%on this news

GH Research Welcomes White House Executive Order to Accelerate Medical Treatments for Serious Mental Illness

GH Research PLC has expressed support for a recent White House Executive Order aimed at accelerating medical treatments for serious mental illnesses, including psychedelic therapies. The company is advancing its product candidate, GH001, towards a global pivotal Phase 3 program for treatment-resistant depression. The Executive Order aligns with GH Research's commitment to innovative, evidence-based therapies.

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GHRS
Mar 25, 2026
GHRSPhases

GH Research Announces Publication of Phase 2b Results for Mebufotenin (GH001) in JAMA Psychiatry and Reports New Finding of Severity-Independent Efficacy in TRD

GH Research PLC announced the publication of Phase 2b results for GH001 in treatment-resistant depression (TRD) in JAMA Psychiatry. The study demonstrated that GH001's efficacy remains consistent regardless of the number of prior antidepressant treatment failures. This finding supports the potential of GH001 as a transformative therapy for patients with TRD.

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GHRS
Mar 5, 2026
GHRSPhases
▼ -5.1%on this news

GH Research Reports Full Year 2025 Financial Results and Provides Business Update

GH Research PLC reported its financial results for 2025, highlighting the completion of its Phase 2b trial for GH001 in treatment-resistant depression (TRD). The trial met its primary endpoint, showing significant efficacy. The company is now seeking FDA alignment for its Phase 3 program, with a strong cash position of $280.7 million to support its initiatives. However, it reported an increased net loss compared to the previous year.

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GHRS
Jan 15, 2026
GHRSPhases

Exploring the Therapeutic Potential of Mebufotenin (GH001) Across Depressive Disorders ACNP 2026 Mini Panel Chair Michael E. Thase, MD Presenters Lisa Harding, MD Kristina M. Deligiannidis, MD Roger S. McIntyre, MD, FRCP

GH Research is exploring the therapeutic potential of Mebufotenin (GH001) across multiple depressive disorders, highlighted in a panel at the ACNP 2026 conference. Findings from a Phase 2b clinical trial reveal that GH001 provides rapid and significant antidepressant effects, particularly in treatment-resistant depression. The therapy has shown a good safety profile and beneficial effects on maternal functioning in postpartum depression. Overall, the results suggest that GH001 could fulfill a crucial need in the psychiatric treatment landscape.

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GHRS
Jan 13, 2026
GHRSPhases

GH001 Improves Illness Severity, Anxiety Symptoms, and Quality of Life in Patients with Treatment-Resistant Depression Michael E. Thase, MD Department of Psychiatry, University of Pennsylvania and Corporal Michael J. Cre

GH001, a synthetic form of mebufotenin, demonstrates promising efficacy in improving illness severity, anxiety symptoms, and overall quality of life in patients suffering from treatment-resistant depression (TRD). This drug has been well tolerated in early-stage trials, addressing an unmet need for effective treatment options in this patient population. The Phase 2b trial revealed significant improvements in depressive symptoms over a six-month period, suggesting GH001 may offer rapid therapeutic benefits for those with limited treatment responses.

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GHRS
Jan 8, 2026
GHRSPhases
▼ -13.4%on this newsshared move

Figure 3. Double-Blind Part: MADRS Suicidality Item 10 Responses at Baseline and Day 8 GH001 (n=40) Placebo (n=41) 6 5 4 3 2 1 0 100 90 80 70 60 50 40 30 20 10 0 Baseline Day 8 Baseline Day 8 Percentage of Patients by MA

The Phase 2b trial of GH001, a treatment for treatment-resistant depression (TRD), shows promising results. In a controlled environment, patients exhibited significant reductions in depressive symptoms over a six-month open-label extension phase. The treatment was well tolerated, and there were no incidents of treatment-emergent suicidal intent, emphasizing safety. However, one patient did report temporary suicidal ideation, which resolved spontaneously, highlighting the need for careful patient selection.

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GHRS
Jan 5, 2026
GHRSFDA Updates
▲ +16.8%on this newsshared move

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH Research PLC announced that the FDA has lifted the clinical hold on its IND for GH001, allowing U.S. subject enrollment. This development is a significant milestone for the company, as it prepares to initiate a global pivotal Phase 3 program in 2026. Experts have noted GH001's potential to transform treatment for patients with treatment-resistant depression.

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GHRS
Jan 5, 2026
GHRSFDA Updates
▲ +16.8%on this newsshared move

GH Research to Announce IND Status for GH001

GH Research PLC will announce the status of its Investigational New Drug Application for GH001 on January 5, 2026. The company is focused on developing treatments for treatment-resistant depression (TRD) and has reported positive results from its Phase 2b trial. The update will provide insights into their pivotal Phase 3 program.

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GHRS
Jan 2, 2026
GHRSFDA Updates

GH Research to Announce IND Status for GH001 DUBLIN

GH Research PLC is set to provide an update on the Investigational New Drug Application (IND) for its product candidate GH001, aimed at treating treatment-resistant depression (TRD). This update will occur on January 5, 2026, and follows promising results from the Phase 2b trial, where GH001 demonstrated significant efficacy. The drug employs a proprietary inhalation approach using mebufotenin, which the company believes could revolutionize TRD treatment.

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GHRS
Nov 24, 2025
GHRSPhases

GH001 Improves Illness Severity, Anxiety Symptoms, and Quality of Life in Patients with Treatment-Resistant Depression Michael E. Thase 1,2 *, Bernhard T. Baune 3,4,5 , Narc s Cardoner 6 , Kelly Doolin 7 , Rosa Maria Due

The Phase 2b trial for GH001 demonstrated its efficacy in treating patients with treatment-resistant depression (TRD), revealing significant improvements in depressive symptoms, anxiety, and overall quality of life. In the study involving 81 patients, GH001 led to a notable reduction in scores on various assessment scales such as MADRS, CGI-S, and HAM-A. Remarkably, 73% of the patients who completed the open-label extension achieved remission. The findings suggest sustained benefits over a six-month period with few required treatments, showcasing GH001's potential as an effective therapy for TRD.

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GHRS
Nov 6, 2025
GHRSFDA Updates

GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates

GH Research PLC reported its Q3 2025 financial results, highlighting progress in its clinical development of GH001 for treatment-resistant depression. The company received FDA communication regarding a clinical hold, with one topic remaining to be addressed. The Phase 2b trial results showed significant efficacy, and the company plans to initiate a global pivotal program in 2026.

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GHRS
Nov 6, 2025
GHRSGeneral

GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive loss Three months ended September 30, Nine months ended

GH Research PLC reported its unaudited interim financial results for the three and nine months ending September 30, 2025. The company experienced a comprehensive loss of $14.1 million during the recent quarter, reflecting increased operating expenses. Notably, the company raised $139.8 million from a public offering, contributing to a rise in total assets to $302 million and a strong cash position of $249.7 million. Despite the financial challenges, the company remains focused on developing new therapies for treatment-resistant depression.

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GHRS
Oct 17, 2025
GHRSPhases

Suicidal Ideation and Behavior in Patients With Treatment-Resistant Depression Treated With GH001 Sanjay J. Mathew 1,* , Bernhard T. Baune 2,3,4 , Narc s Cardoner 5 , Wies aw J. Cuba a 6 , Kelly Doolin 7 , Rosa Maria Due

A Phase 2b trial of GH001, a synthetic form of mebufotenin, has demonstrated its potential as a treatment for patients with treatment-resistant depression (TRD). The trial involved 81 patients and showed that GH001 resulted in significant improvements in depressive symptoms without increasing the risk of suicidal ideation or behavior. While one moderate treatment-emergent adverse event of suicidal ideation was noted, it resolved spontaneously, and overall, the therapy was well tolerated. These results suggest that GH001 may be a promising option for addressing the unmet needs in TRD management.

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GHRS
Oct 14, 2025
GHRSPhases

Long-Term Data for GH001 in Patients with Treatment-Resistant Depression Wies aw J. Cuba a, MD, PhD Department of Psychiatry, Faculty of Medicine, Medical University of Gda sk, Gda sk, Poland Co-authors: Malek Bajbouj, B

Recent long-term data for GH001, a synthetic form of mebufotenin, indicates its potential effectiveness in treating patients with treatment-resistant depression (TRD). The drug has shown promise in inducing rapid remission of depressive symptoms, demonstrating a favorable safety profile in early trials. An open-label extension of a Phase 2b trial involved patients receiving up to five treatments, further highlighting its potential to address a significant unmet need in psychiatric care. The findings suggest GH001 could play a vital role in improving outcomes for patients suffering from TRD.

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GHRS
Oct 9, 2025
GHRSConferences/Events

GH Research Announces Novel Therapies Symposium Presentation and Posters at the 2025 ECNP Congress

GH Research PLC announced the acceptance of a presentation and two posters at the 2025 ECNP Congress. The presentation will feature long-term clinical data on GH001 for treatment-resistant depression (TRD). The findings indicate strong safety and tolerability, with no serious adverse events reported. Additionally, an Industry Satellite Symposium will explore rapid-acting antidepressants.

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GHRS
Sep 9, 2025
GHRSPhases

Event # n (%) Any TEAE 18 5 (83.3) Mild 15 5 (83.3) Moderate 2 2 (33.3) Severe 1 1 (16.7) Treatment-related TEAEs 18 5 (83.3) Treatment-emergent SAE 0 0 Death 0 0 TEAEs by Preferred Term Headache 4 3 (50.0) Nausea 6 2 (3

GH Research reported positive results from their Phase 2a trial of GH001, a synthetic form of mebufotenin, for treating patients with Bipolar II Disorder and current major depressive episodes. The study demonstrated a significant reduction in depression scores after treatment, with notable improvements in patient outcomes reflected in the Montgomery-Åsberg Depression Rating Scale (MADRS). No serious treatment-related adverse events were reported, highlighting the safety profile of GH001. The trial indicates potential for GH001 as a new therapeutic option in managing depressive symptoms in this patient population.

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GHRS
Aug 7, 2025
GHRSGeneral

GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive loss Three months ended June 30, Six months ended

GH Research PLC reported its interim financial results for the period ending June 30, 2025. The company experienced a significant increase in operating expenses and a larger loss compared to the same period in 2024. Despite these challenges, GH Research successfully raised $139.8 million through a public offering, contributing to a notable increase in cash reserves. The company's asset position improved, but it continues to face challenges in managing its operational costs.

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GHRS
Jul 23, 2025
GHRSPhases
▼ -14.7%on this news

GH Research Announces Global Pivotal Program Plans and Further Development Updates

GH Research PLC has provided updates on its pivotal program plans and the development of its product candidates, GH001 and GH002. The company has responded to a clinical hold from the FDA for GH001, addressing most concerns, while the Phase 2b trial results show promising efficacy in treatment-resistant depression. GH002 has completed Phase 1 trials with positive safety outcomes. The global pivotal program is expected to start in 2026.

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GHRS
Jun 20, 2025
GHRSFDA Updates

GH Research Submits Complete IND Hold Response to FDA Ahead of Schedule

GH Research PLC has submitted a complete response to the FDA regarding the clinical hold on its Investigational New Drug Application for GH001. This submission was made ahead of schedule and includes comprehensive data and completed toxicology studies. The company is optimistic about the potential of GH001 to transform treatment for treatment-resistant depression (TRD).

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GHRS
Jun 18, 2025
GHRSGeneral

Notice of Annual General Meeting to be held on 31 July 2025 GH Research plc (the Company or GH Research ) THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt as to the action to be t

GH Research plc has announced its Annual General Meeting (AGM) scheduled for July 31, 2025, in Dublin, Ireland. Key resolutions will focus on the re-election of directors, appointment of auditors, and renewal of share issuance authorities to ensure capital flexibility. This AGM aims to engage shareholders in decisions impacting the company’s financial strategies and governance. The need for shareholder approval is emphasized to maintain the status quo and avoid potential disadvantages in capital-raising activities.

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GHRS
May 27, 2025
GHRSPhases

Safety and Efficacy of GH001 in Treatment-Resistant Depression: Results From a Phase 2b, Double-Blind, Randomized Controlled Trial Michael E. Thase, MD Department of Psychiatry, University of Pennsylvania, and Corporal M

A Phase 2b double-blind randomized controlled trial evaluated GH001, a synthetic version of mebufotenin, in patients with treatment-resistant depression (TRD). The study identified that GH001 is well tolerated and has the potential to induce ultra-rapid remission of depressive symptoms. The trial included 81 participants, all of whom completed the double-blind phase. The findings underscore the urgent need for new treatments in the field of mental health, particularly for patients lacking effective existing options.

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GHRS
May 21, 2025
GHRSPhases
▼ -5.3%on this newsshared move

Safety and Efficacy of GH001 in Treatment-Resistant Depression: Results From a Phase 2b, Double-Blind, Randomized Controlled Trial Michael E. Thase,1,2* Bernhard T. Baune,3 Narc s Cardoner,4 Rosa Maria Due as Herrero,5 L

The Phase 2b trial of GH001, a synthetic form of mebufotenin for treatment-resistant depression (TRD), demonstrated positive safety and efficacy outcomes. The double-blind trial involved randomization of patients to receive varying doses of GH001 against a placebo, assessing changes in depression severity over time. Initial findings suggest the potential for rapid and sustained relief of depressive symptoms in patients who have not responded to existing treatments. The study results provide hope for addressing the significant unmet need for effective TRD therapies.

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GHRS
May 15, 2025
GHRSConferences/Events
▲ +7.2%on this news· ran to +25% by day 3

GH Research Announces Acceptance of Pharmaceutical Pipeline Presentation and Late-Breaking Posters at the American Society of Clinical Psychopharmacology 2025 Annual Meeting

GH Research PLC announced the acceptance of a Pharmaceutical Pipeline Presentation and late-breaking posters at the ASCP Annual Meeting. Professor Michael E. Thase will present Phase 2b trial data for GH001 in treatment-resistant depression. Additionally, late-breaking posters will cover safety data and a proof-of-concept trial in postpartum depression, highlighting GH001's potential as a transformative treatment.

Read more →
GHRS
Feb 27, 2025
GHRSPhases

GH Research Reports Full Year 2024 Financial Results and Provides Business Updates Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for completion of last patient visit in the ope

GH Research PLC reported its financial results for 2024 and updates on its clinical trials. The Phase 2b trial of GH001 for treatment-resistant depression demonstrated significant treatment effects with a high patient remission rate. Additionally, the firm is addressing FDA requests related to an IND hold for its aerosol delivery device. While the company achieved notable clinical milestones, it also reported an increase in financial losses compared to the previous year.

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GHRS
Feb 5, 2025
GHRSGeneral
▼ -8.1%on this news

GH Research Announces Pricing of $150 Million Public Offering

GH Research PLC has announced the pricing of a public offering of 10 million ordinary shares at $15 each, aiming to raise around $150 million. The offering is set to close on February 6, 2025, pending customary conditions. The company is focused on developing treatments for depression, particularly mebufotenin therapies for treatment-resistant depression.

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GHRS
Feb 3, 2025
GHRSGeneral
▼ -9.3%on this news· ran to -23% by day 3shared move

GH Research Announces Proposed Public Offering

GH Research PLC has announced a proposed public offering of $150 million in ordinary shares, aimed at advancing its clinical-stage biopharmaceutical initiatives focused on depression treatment. The company may also grant underwriters an option for an additional $22.5 million in shares. The offering's completion is contingent on market conditions and other factors.

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GHRS
Feb 3, 2025
GHRSGeneral
▲ +69.7%on this newsshared move

GH Research Announces Proposed Public Offering Dublin, Ireland

GH Research PLC has announced a proposed public offering of $150 million in ordinary shares to bolster its capital for developing treatments for depression. This offering will be conducted in the United States, with additional shares potentially available through an underwriter option. The offering's completion is uncertain and hinges on market conditions. GH Research aims to address treatment-resistant depression, but risks associated with market reception remain.

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GHRS
Jan 31, 2025
GHRSPhases
▲ +9.4%on this news· ran to +86% by day 1shared move

GH Research to Provide Update on Phase 2b Trial with GH001 in TRD Dublin, Ireland

GH Research PLC will hold a conference call on February 3, 2025, to update stakeholders on the Phase 2b trial of GH001 for treatment-resistant depression (TRD). The trial is randomized, double-blind, and placebo-controlled, aiming to provide insights into the efficacy of their novel treatment. Previous trials indicated that 87.5% of TRD patients achieved ultra-rapid remission with GH001, suggesting its transformative potential in this area.

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GHRS
Jan 22, 2025
GHRSPhases

GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction Primary endpoint met, GH001 led to an ultra-rapid anti-depressant effect with a si

GH Research PLC reported successful results from its Phase 2b trial of GH001, an inhalable treatment for treatment-resistant depression (TRD). The trial met its primary endpoint with a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score, showing a placebo-adjusted reduction of -15.5 points. All secondary endpoints were also met, indicating consistent results. GH001 was well tolerated among participants, with no serious adverse events noted during the trial, paving the way for further development in clinical psychiatry.

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GHRS
Jan 10, 2025
GHRSPhases

GH Research Announces Primary Endpoint Met in Two Phase 2a POC Trials with GH001 and Completion of All FDA Requests to Address IND Hold with No Findings of Respiratory Toxicity in Non-Rodents Primary endpoint met in phas

GH Research PLC announced that its GH001 met the primary endpoint in two Phase 2a proof-of-concept trials, one for postpartum depression and another for bipolar II disorder, demonstrating significant reductions in depression scores. The drug was found to be well tolerated with no serious adverse events, and 100% of patients in the postpartum depression trial achieved remission by Day 8. The completion of FDA requests has resolved an IND hold related to inhalation toxicology studies. GH Research plans to further engage with the FDA regarding GH001's application in mid-2025.

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GHRS
Nov 14, 2024
GHRSGeneral

GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive income Three months ended September 30, Nine months ended

GH Research PLC reported its unaudited interim financial results for the three and nine months ended September 30, 2024. The company has experienced a significant total comprehensive loss of $30.014 million during the period, reflecting increased operating expenses. Despite these losses, cash and cash equivalents rose to $90.1 million, indicating some financial stability. The report outlines ongoing investments in research and development, particularly in innovative therapeutic approaches for psychiatric conditions.

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GHRS
Sep 20, 2024
GHRSPhases
▼ -5.4%on this news

09/2024 1 Review of Ongoing Phase 2b Treatment-Resistant Depression Clinical Trial (GH001-TRD-201) Wies aw J. Cuba a Medical University of Gda sk Author Disclosure 19/09/2024 2 Conflict of interest statement regarding my

The ongoing Phase 2b clinical trial GH001-TRD-201 focuses on using mebufotenin, an inhaled psychedelic treatment for treatment-resistant depression. The trial, involving an individualized dosing regimen, aims to evaluate the efficacy and safety of the drug, which has demonstrated a rapid onset of effects. Results from previous trials indicate a good safety profile with no serious adverse events, though the drug has yet to gain regulatory approval. The presentation of the trial details also highlights possible conflicts of interest for the author involved.

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GHRS
Sep 3, 2024
GHRSGeneral
▼ -6.6%on this news· ran to -22% by day 3

GH Research Announces Appointment of Dr. Velichka "Villy" Valcheva to Chief Executive Officer

GH Research PLC has announced the promotion of Dr. Velichka "Villy" Valcheva to Chief Executive Officer, succeeding co-founder Dr. Theis Terwey. Dr. Valcheva, who has over 20 years in the biopharma industry, previously served as Chief Medical Officer and was instrumental in advancing the company's clinical programs. Under her leadership, the company is progressing with clinical trials for its mebufotenin therapies targeting treatment-resistant depression. The transition comes as the company readies for the enrollment completion of its phase 2b trial and begins a phase 1 study in the UK.

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GHRS
Sep 3, 2024
GHRSGeneral
▼ -6.6%on this news· ran to -22% by day 3

GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive income Three months ended June 30, Six months ended

GH Research PLC released its unaudited condensed interim financial statements for the period ending June 30, 2024, revealing substantial operational losses. The company reported a loss from operations of $10.4 million, significantly higher than the previous year's $7.7 million. Cash and cash equivalents increased to $87.1 million; however, total comprehensive losses amounted to $20.4 million, primarily driven by rising research and development costs. The financial outlook remains challenging as the company continues to invest heavily in its clinical-stage biopharmaceutical projects without generating revenue.

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GHRS
May 15, 2024
GHRSGeneral

Notice of Annual General Meeting to be held on 27 June 2024 GH Research plc (the Company or GH Research ) THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt as to the action to be t

GH Research plc has announced its Annual General Meeting (AGM) scheduled for June 27, 2024, at 2 PM Irish Standard Time. The meeting will address several resolutions including the re-election of directors and the appointment of auditors. Shareholders are encouraged to review the financial statements and participate in the voting process. The notice emphasizes the importance of shareholder engagement and provides procedural details for attending and voting at the AGM.

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GHRS
May 3, 2024
GHRSGeneral

GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive income Three Months Ended

GH Research PLC reported its unaudited condensed consolidated interim financial statements for the three months ended March 31, 2024. The company experienced a decreased loss for the period at $7,666K compared to $10,937K in the previous year. However, total comprehensive loss increased to $9,498K, reflecting challenges despite rising finance income. The group maintains a strong current asset position, although substantial accumulated deficits present ongoing financial pressures.

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GHRS
Feb 29, 2024
GHRSPhases
▲ +7.9%on this news

GH Research Reports Full Year 2023 Financial Results and Provides Business Updates Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase i

GH Research PLC has reported its financial results for 2023, revealing a net loss of $35.6 million. The company is advancing its Phase 2b clinical trial for GH001, which is on track for completion in Q3 2024, alongside ongoing proof-of-concept trials in postpartum and bipolar depression. While recruitment is strong for the TRD trial, the FDA has put the IND application for GH001 on hold, necessitating additional toxicology studies. However, GH002 has completed its Phase 1 trial successfully, demonstrating well-tolerated psychoactive effects.

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GHRS
Jan 18, 2024
GHRSFDA Updates

GH Research Announces Grant of European Patent Covering all Mebufotenin (5-MeO-DMT) and Mebufotenin Salt Products For Use in the Treatment of Major Depressive Disorder and Treatment-Resistant Depression

GH Research PLC has been granted a European patent for mebufotenin (5-MeO-DMT) for the treatment of major depressive disorder and treatment-resistant depression. This patent, effective February 14, 2024, covers various administration methods, bolstering the company's position in developing rapid-acting antidepressant therapies. The company is also pursuing similar patents in the U.S. and globally, as part of its broader strategy to enhance its intellectual property portfolio and explore further research opportunities.

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GHRS
Jan 5, 2024
GHRSConferences/Events

GH Research PLC (NASDAQ: GHRS) January 2024 Corporate Presentation 1 This presentation has been prepared by GH Research PLC ("GH Research") for informational purposes only and not for any other purpose. Nothing contained

GH Research PLC has presented an update concerning its ongoing research and development efforts, particularly focusing on the clinical status of their lead product candidate, GH001, a treatment for Treatment-Resistant Depression. This product is currently in a Phase 2b trial, with additional trials underway for bipolar disorder and postpartum depression. However, the company faces hurdles including a clinical hold affecting progress and potential uncertainties around funding and market conditions. The presentation emphasizes both the promise of the product and the significant challenges that lie ahead.

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GHRS
Nov 9, 2023
GHRSGeneral

Unaudited condensed consolidated interim statement of comprehensive income Three Months Ended September 30, Nine Months Ended

GH Research PLC has reported its unaudited interim financial results for the three and nine months ended September 30, 2023. The company recorded a net loss of $24.3 million, significantly higher than the $5.9 million loss reported the previous year. The increase in operating expenses, particularly in research and development, contributed to the overall financial downturn. The company's cash and cash equivalents have decreased notably to $86.4 million, indicating a potential liquidity concern. Total comprehensive loss also rose to $25.7 million compared to $21.6 million for the same period last year.

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GHRS
Oct 6, 2023
GHRSPhases

Concentration (nM) Mebufotenin Psilocin DMT Determination of inhibition constants for three psychedelic drugs for 5-HT1A and 5-HT2A receptors in postmortem human brain V. McDonald\, S. Cheetham\, M. Burnett\, C. K. Olsen

The study compares the affinity of three psychedelic drugs—mebufotenin, psilocin, and DMT—for serotonin receptors 5-HT1A and 5-HT2A in postmortem human brain tissues. Mebufotenin shows a high affinity for the 5-HT1A receptor with a significant selectivity over the 5-HT2A receptor. The findings may help explain different psychoactive effects of these drugs and support ongoing clinical trials for mebufotenin in treating treatment-resistant depression. Psilocin and DMT are identified as non-selective ligands with moderate affinity for both receptors.

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GHRS
Sep 29, 2023
GHRSPhases

GH Research Provides Updates and Guidance on its Clinical Development Program for GH001 in Treatment-Resistant Depression

GH Research PLC has updated its clinical development program for GH001, an inhalable treatment for treatment-resistant depression. Following a successful Phase 1/2 trial, the company is now initiating a European Phase 2b trial expected to recruit around 80 patients across multiple sites. However, GH001's Investigational New Drug Application is currently on hold by the FDA due to insufficient information to assess risks. The company is awaiting further details from the FDA and plans to provide updates in its next earnings release.

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GHRS
Aug 23, 2023
GHRSGeneral

Unaudited condensed consolidated interim statement of comprehensive income Three months ended June 30, Six months ended

GH Research PLC reported its unaudited condensed consolidated interim financial results for the three and six months ending June 30, 2023. The company saw an increase in research and development expenses, contributing to greater operating losses which totaled $9,925 for Q2 2023. For the first half of the year, GH Research recorded a total comprehensive loss of $17,835. The total cash and cash equivalents declined significantly during this period, highlighting financial pressures faced by the company.

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GHRS
Jul 19, 2023
GHRSGeneral

Notice of Annual General Meeting to be held on 31 August 2023 GH Research plc (the Company or GH Research ) THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt as to the action to be

GH Research plc will hold its Annual General Meeting (AGM) on 31 August 2023, at 2 pm Irish Standard Time. Shareholders will vote on the re-election of directors and the appointment of auditors, among other matters. The board unanimously recommends voting in favor of the proposed resolutions. The 2022 Irish statutory financial statements will also be reviewed but will not require shareholder approval.

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GHRS
May 11, 2023
GHRSGeneral

Exhibi 99.1 UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE THREE MONTHS ENDED MARCH 31, 2023 GH RESEARCH PLC Unaudited condensed consolidated interim statement of comprehensive income Three months

GH Research PLC reported its unaudited condensed consolidated interim financial statements for the three months ending March 31, 2023. The company recorded an increased loss from operations of $10.9 million compared to $5.8 million in the same period last year, driven largely by rising research and development costs. While cash and cash equivalents remain substantial at $105 million, foreign exchange losses and operating expenses have contributed to a comprehensive loss of $8.5 million for the period. Despite these challenges, the company believes it has adequate financial resources to manage its operations over the next year.

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GHRS
Mar 2, 2023
GHRSGeneral

GH Research Reports Full Year 2022 Financial Results and Provides Business Updates

GH Research PLC reported its financial results for the full year 2022, highlighting its progress in clinical trials and business developments. The company has initiated a Phase 2b trial for its inhalable mebufotenin product, GH001, targeting treatment-resistant depression. As of December 31, 2022, GH Research maintains a solid cash position of $251.7 million, sufficient for operational funding into 2026. The net loss has increased compared to the previous year, reflecting rising research and administrative expenses.

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GHRS
Jan 9, 2023
GHRSPhases
▼ -13%on this news

GH Research Provides Business Updates and Highlights Key Upcoming Milestones - Initial approvals received for Phase 2b trial of GH001 in TRD (GH001-TRD-201), initiation of this trial expected in Q1 2023 - Development of

GH Research PLC announced key updates regarding its clinical development programs and milestones. The company received initial regulatory and ethical approvals for its Phase 2b trial of GH001 in treatment-resistant depression (TRD), expected to start in Q1 2023. In addition, the firm is advancing its proprietary aerosol delivery device for GH001 and has initiated a Phase 1 trial for its injectable product candidate, GH002. The World Health Organization has also selected 'mebufotenin' as the International Nonproprietary Name for 5-MeO-DMT, which will be used for communication going forward.

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GHRS
Nov 10, 2022
GHRSGeneral
▲ +7%on this news· ran to +20% by day 3

Unaudited condensed consolidated interim statement of comprehensive income Three months ended September 30, Nine months ended

Unaudited condensed consolidated interim statement of comprehensive income Three months ended September 30, Nine months ended September 30, 2022 2021 2022 2021 Note $'000 $'000 $'000 $'000 Operating expenses Research and development (

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GHRS
Oct 14, 2022
GHRSGeneral

INTRODUCTION Current established treatments for depression are slow - acting, often taking several weeks before potential effects appear, and about one third of patient do not reach remission even after 4 treatment steps

INTRODUCTION Current established treatments for depression are slow - acting, often taking several weeks before potential effects appear, and about one third of patient do not reach remission even after 4 treatment steps 1 . 5 - Methoxy - N,N - dimethyltryptamine ( 5 - MeO - DMT)

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GHRS
Sep 21, 2022
GHRSPhases

A Phase 1/2 Trial of GH001, a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation, inPatients with Treatment-Resistant Depression (TRD) 1 Clinicaltrials.gov ID NCT04698603 GH001-TRD-102 ICPR 2022 Johannes Reckweg1, Ce

A Phase 1/2 Trial of GH001, a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation, inPatients with Treatment-Resistant Depression (TRD) 1 Clinicaltrials.gov ID NCT04698603 GH001-TRD-102 ICPR 2022 Johannes Reckweg1, Cees van Leeuwen1, C cile Henquet2, Th r se van Amelsvoort2,

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GHRS
Aug 11, 2022
GHRSGeneral

Notice of Annual General Meeting to be held on 22 September 2022 GH Research PLC ( the Company or GH Research) THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt as to the action to

Notice of Annual General Meeting to be held on 22 September 2022 THIS DOCUMENT IS IMPORTANT AND REQUIRES YOUR IMMEDIATE ATTENTION. If you are in any doubt as to the action to be taken, you should consult with your independent financial adviser who, if you are taking advice in

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GHRS
May 31, 2022
GHRSPhases

A Phase 1/2 Trial of GH001, a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation, inPatients with Treatment-Resistant Depression (TRD) 1 Clinicaltrials.gov ID NCT04698603 GH001-TRD-102 ASCP 2022 Johannes Reckweg1, Ce

A Phase 1/2 Trial of GH001, a Vaporized 5-Methoxy-N,N-Dimethyltryptamine Formulation, inPatients with Treatment-Resistant Depression (TRD) 1 Clinicaltrials.gov ID NCT04698603 GH001-TRD-102 ASCP 2022 Johannes Reckweg1, Cees van Leeuwen1, C cile Henquet2, Therese van Amelsvoort2,

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GHRS
May 18, 2022
GHRSGeneral
▼ -10%on this news

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE THREE MONTHS ENDED MARCH 31, 2022 GH RESEARCH PLC Condensed consolidated interim statement of comprehensive income Three months ended

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE THREE MONTHS ENDED MARCH 31, 2022 Condensed consolidated interim statement of comprehensive income Three months ended March 31, 2022 2021 Note $'000 $'000 Operating expenses Research and

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GHRS
Mar 28, 2022
GHRSGeneral

GH Research Reports Full Year 2021 Financial Results and Provides Business Updates Dublin, Ireland

GH Research Reports Full Year 2021 Financial Results and Provides Business Updates Dublin, Ireland, March 28, 2022 - GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, tod

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GHRS
Mar 4, 2022
GHRSConferences/Events
▼ -6.9%on this news

Corporate PresentationGH Research PLC (NASDAQ: GHRS) GH Research March 2022 2022 GH Research PLC Disclaimer Regarding Forward-Looking Statements This presentation has been prepared by GH Research PLC ("GH Research") for

1 Corporate PresentationGH Research PLC (NASDAQ: GHRS) GH Research March 2022 2022 GH Research Disclaimer Regarding Forward-Looking Statements This presentation has been prepared by GH Research PLC ("GH Research") for informational purposes only and not for any other purpose. N

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GHRS
Dec 6, 2021
GHRSGeneral
▲ +21.9%on this news

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021 GH RESEARCH PLC Condensed consolidated interim statement of comprehensive income Three months ended Sep

UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS FOR THE THREE AND NINE MONTHS ENDED Condensed consolidated interim statement of comprehensive income Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 Note $'00

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GHRS
Dec 6, 2021
GHRSPhases
▲ +21.9%on this news

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression Primary endpoint met in Phase 2 part of clinical trial for GH001 in TRD - 7 of 8 pat

GH Research Announces Successful Outcome of the Phase 2 part of its Phase 1/2 Clinical Trial of GH001 in Treatment-Resistant Depression Dublin, Ireland, December 6, 2021 - GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the tr

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GHRS
Oct 26, 2021
GHRSConferences/Events

Corporate Presentation GH Research PLC (NASDAQ: GHRS) GH Research October 2021 2021 GH Research PLC Disclaimer Regarding Roadshow Communications and Forward - Looking Statements This presentation has been prepared by GH

1 Corporate Presentation GH Research PLC (NASDAQ: GHRS) GH Research October 2021 2021 GH Research PLC Disclaimer Regarding Roadshow Communications and Forward - Looking Statements This presentation has been prepared by GH Research PLC ("GH Research") for informational purposes o

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GHRS
Sep 23, 2021
GHRSGeneral

UNAUDITED CONDENSED CONSOLIDATED INTERIM Financial statements for the THREE and SIX MONTHS ended JUNE 30, 2021 GH RESEARCH PLC Condensed consolidated interim statement of comprehensive income Three months ended June 30,

CONSOLIDATED INTERIM Financial statements for the THREE and SIX MONTHS ended Condensed consolidated interim statement of comprehensive income Three months ended June 30, Six months ended June 30, 2021 2020 2021 2020 Note $'000 $'000 $'000 $'000 Operating expen

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