GH Research PLC develops clinical-stage mebufotenin therapies for depression, with an initial focus on treatment-resistant depression. News about GHRS centers on GH001, its proprietary inhaled mebufotenin product candidate, including clinical trial results, peer-reviewed publications, medical-conference presentations, and FDA/IND regulatory updates.
Company updates also reference GH002, its proprietary intravenous mebufotenin product candidate, and broader clinical work across depressive disorders. Recurring financial and corporate items include full-year and quarterly results, cash and capital-structure disclosures, shareholder voting matters, and business updates tied to the company’s research and development segment.
GH Research (Nasdaq: GHRS) priced an underwritten offering of 6,527,779 ordinary shares at $18.00 per share for gross proceeds of approximately $117.5 million. The offering is expected to close on April 30, 2026, subject to customary closing conditions.
Joint book-runners are Stifel, Cantor and RBC Capital Markets; Lynx1 Capital initiated the offering with participation from Deep Track Capital and Foresite Capital. A registration statement was declared effective March 7, 2025.
GH Research (Nasdaq: GHRS) welcomed the White House Executive Order signed April 18, 2026, directing coordinated federal action to accelerate development and patient access for treatments for serious mental illness, including psychedelic medical therapies.
GH Research said it remains focused on advancing GH001, its inhaled mebufotenin candidate, toward initiation of a global pivotal Phase 3 program in treatment‑resistant depression in 2026.
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.
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.
GH Research (Nasdaq: GHRS) announced that the U.S. Food and Drug Administration has lifted the clinical hold on its IND for GH001, enabling U.S. subject enrollment and advancing plans for a global Phase 3 program targeted to start in 2026. The company said it will seek FDA alignment to replicate the Phase 2b design.
Key Phase 2b results cited: a placebo-adjusted -15.5 point MADRS reduction at Day 8 (p<0.0001), 57.5% remission at Day 8, 73% remission at six months with ~4 treatments on average, short psychoactive exposure (~11 minutes median), and no serious treatment-related adverse events.
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.
GH Research (Nasdaq: GHRS) reported third quarter 2025 results and clinical updates on November 6, 2025. Key clinical highlights: the Phase 2b TRD trial met its primary endpoint with a placebo‑adjusted -15.5 point reduction in MADRS total score on Day 8 (p<0.0001), the open‑label extension showed a 73% remission rate at 6 months, no treatment‑related serious adverse events, and no treatment‑emergent suicidal intent or behavior during six months. Regulatory: engagement with the FDA on the IND complete response is ongoing with one hold topic remaining. Financials: cash, cash equivalents and marketable securities of $293.9 million as of September 30, 2025; R&D $10.6M; G&A $6.0M; net loss $14.0M, or $0.23 per share for the quarter. The company expects to initiate a global pivotal program in 2026.
GH Research (Nasdaq: GHRS) announced accepted presentations and posters at the 38th ECNP Congress in Amsterdam, Oct 11–14, 2025. A Novel Therapies Symposium presentation on Oct 13, 3:00–4:20pm CET will report long‑term safety and efficacy data from the open‑label extension of the Phase 2b GH001-TRD-201 trial in treatment‑resistant depression (TRD). Two posters report psychoactive effects and OLE safety/tolerability; an Industry Satellite Symposium on rapid‑acting antidepressants is set for Oct 12, 8:40–10:00am CET.
GH Research (NASDAQ:GHRS) reported Q2 2025 financial results and provided significant updates on its clinical programs. The company's lead candidate GH001 achieved remarkable results in its Phase 2b trial for Treatment-Resistant Depression (TRD), demonstrating a 73% remission rate at 6 months with infrequent treatments and no required psychotherapy.
The company maintains a strong financial position with $308.7 million in cash and equivalents, bolstered by a $150 million public offering in Q1 2025. Q2 net loss improved to $0.15 per share from $0.20 year-over-year. GH Research continues engagement with FDA regarding the IND clinical hold response for GH001, with only one hold topic remaining. The company plans to initiate its global pivotal program in 2026.
GH Research (NASDAQ:GHRS) has provided significant updates on its clinical programs and development plans. The company is addressing the final FDA hold topic for its GH001 IND application, related to respiratory tract histology findings in rats. The company's Phase 2b trial in treatment-resistant depression (TRD) achieved impressive results, with a 73% remission rate at 6 months and a significant -15.5 point reduction in MADRS scores.
The treatment demonstrated strong safety profiles with no serious adverse events and no treatment-emergent suicidal ideation. The company's GH002 program showed positive Phase 1 results, with plans for FDA IND submission in Q4 2025. GH Research is preparing for a global pivotal program launch in 2026, with ongoing CRO selection and regulatory preparations.