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 (Nasdaq: GHRS) reported peer-reviewed Phase 2b results for mebufotenin (GH001) in treatment-resistant depression, published in JAMA Psychiatry on March 25, 2026.A post hoc analysis in Psychopharmacology Bulletin found efficacy independent of prior antidepressant failures, with Day 8 remission 53.9%–63.6% and Month 6 remission 61.5%–85.7% across subgroups.

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

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GH Research Reports Full Year 2025 Financial Results and Provides Business Update GH Research (Nasdaq: GHRS) reported full‑year 2025 results and a clinical update. Key highlights include cash of $280.7M at December 31, 2025, completion of a Phase 2b GH001 trial in treatment‑resistant depression that met its primary endpoint, and ongoing planning for a global Phase 3 program.The Phase 2b showed a placebo‑adjusted MADRS reduction of -15.5 points at Day 8, 57.5% remission versus 0% on placebo, and a 73% six‑month remission rate in an open‑label extension; safety signals were reported as favorable.

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

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GH Research to Announce IND Status for GH001 GH Research (Nasdaq: GHRS) said it will provide an update on the Investigational New Drug (IND) status for GH001 and on its global pivotal Phase 3 program in treatment-resistant depression (TRD).The company plans to deliver the update on Monday, January 5, 2026 at 7:00 a.m. EST. The announcement focuses on regulatory progress and the Phase 3 program timeline.

#GHRS GH Research to Announce IND Status for GH001

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

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GH Research Announces Global Pivotal Program Plans and Further Development Updates Engagement with FDA on GH001 IND complete response ongoing The fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no psychotherapy Treatment was well tolerated and no treatment related serious adverse events were reported.

#GHRS GH Research Announces Global Pivotal Program Plans and Further Development Updates

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GH Research Submits Complete IND Hold Response to FDA Ahead of Schedule GH Research PLC (GHRS) has announced the submission of its complete response to the FDA regarding the clinical hold on its Investigational New Drug Application (IND) for GH001, a treatment in development for depression. The company submitted the response in June 2025, ahead of their planned schedule. According to CEO Dr. Velichka Valcheva, the response includes comprehensive data and completed toxicology studies addressing the FDA's specific requests. The company emphasized its commitment to working with the FDA to advance GH001's development for patient treatment.

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

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GH Research Announces Acceptance of Pharmaceutical Pipeline Presentation and Late-Breaking Posters at the American Society of Clinical Psychopharmacology 2025 Annual Meeting GH Research (Nasdaq: GHRS) announced the acceptance of multiple presentations at the American Society of Clinical Psychopharmacology Annual Meeting 2025, showcasing clinical data for their drug candidate GH001. The presentations include results from a Phase 2b trial in treatment-resistant depression (TRD), a Phase 2a trial in postpartum depression, and early-stage trials. Notably, in the postpartum depression trial, all ten participants achieved remission by Day 8. Additionally, a separate presentation at the International Society for Bipolar Disorders Conference will present Phase 2a results showing GH001's efficacy in bipolar II disorder, where it demonstrated a 52% mean reduction in depressive symptoms by Day 8. The drug was well-tolerated across all trials with no serious adverse events reported.

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

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GH Research Reports First Quarter 2025 Financial Results and Provides Business Updates GH Research (NASDAQ: GHRS) reported significant progress in Q1 2025, with their Phase 2b trial of GH001 for treatment-resistant depression (TRD) meeting its primary endpoint. The trial showed a -15.5 point placebo-adjusted MADRS reduction and achieved a 57.5% remission rate compared to 0% in the placebo group. The company's cash position stands at $315.3 million, bolstered by a $150 million public offering. The company reported progress in proof-of-concept trials for bipolar II disorder and postpartum depression. Their IND application for GH001 remains on clinical hold, with a full response planned for mid-2025. Q1 financial results showed R&D expenses of $7.9 million (down from $8.7 million YoY) and G&A expenses of $4.9 million (up from $2.9 million YoY), resulting in a net loss of $10.8 million ($0.19 per share).

#GHRS GH Research Reports First Quarter 2025 Financial Results and Provides Business Updates

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Can GH Research's Depression Drug Change Treatment Paradigms? Phase 2b Shows Striking 57.5% Remission Rate GH001 demonstrated significant efficacy for treatment-resistant depression with strong remission rates and durable effects, backed by $322M in available capital.

#GHRS GH Research Reports Full Year 2024 Financial Results and Provides Business Updates

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Major Biotech Stock Offering: GH Research Secures $150M War Chest Through Share Sale GH Research announces $150M public offering of 10M shares at $15 each, with underwriters granted option for additional 1.5M shares. Major banks lead the offering.

#GHRS GH Research Announces Pricing of $150 Million Public Offering

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Major Capital Raise: GH Research Launches $150M Share Offering to Accelerate Growth GH Research unveils plans for $150M public offering with additional $22.5M underwriter option. Major financial institutions Cantor, Stifel, and RBC Capital Markets lead the offering.

#GHRS GH Research Announces Proposed Public Offering

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BREAKING NEWS: ( NASDAQ: #GHRS ) Primary Endpoint Met in GH Research's Phase 2b GH001Trial in TRD

Revolutionary Depression Treatment Achieves 57.5% Remission Where Others Failed - Phase 2b Results Stun Experts GH001 inhalable therapy demonstrates powerful efficacy with -15.5 point MADRS reduction vs placebo. 77.8% maintained remission at 6 months with minimal treatments needed.

#GHRS GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction

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Major Clinical Data Coming: GH Research's Novel Depression Drug Trial Results Revealed Feb 3 GH Research announces important Phase 2b trial data presentation for GH001, targeting treatment-resistant depression. Join the webcast on February 3 for detailed findings.

#GHRS GH Research to Provide Update on Phase 2b Trial with GH001 in TRD

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#GHRS GH Research Reports Third Quarter 2024 Financial Results and Provides Business Updates

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