Welcome to our dedicated page for Gh Research Plc news (Ticker: GHRS), a resource for investors and traders seeking the latest updates and insights on Gh Research Plc stock.
GH Research PLC (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company focused on developing novel and proprietary mebufotenin therapies, with an initial emphasis on treatment-resistant depression (TRD). News about GH Research frequently centers on clinical trial results, regulatory milestones, and scientific presentations related to its lead inhalable product candidate GH001 and its intravenous candidate GH002.
Investors and observers following GHRS news can expect updates on Phase 2b and open-label extension data for GH001 in TRD, including reported outcomes such as placebo-adjusted MADRS score reductions, remission rates at key time points, and detailed safety and tolerability findings. The company also reports on proof-of-concept trials of GH001 in postpartum depression and bipolar II disorder, highlighting reductions in depressive symptoms and the absence of treatment-related serious adverse events in these early-stage studies.
Another recurring theme in GH Research news is its regulatory interaction with the U.S. Food and Drug Administration (FDA). Press releases have described the clinical hold on the GH001 IND, the completion of requested inhalation toxicology studies and device verification work, submission of a complete response, and ultimately the FDA’s decision to lift the clinical hold, clearing GH001 for U.S. clinical investigation. News items also cover plans for a global pivotal Phase 3 program in TRD and supporting device-bridging studies in healthy volunteers.
GH Research regularly announces scientific conference participation, including oral presentations and posters at meetings such as ECNP, ASCP, ISBD, and ACNP, where external investigators present data on GH001’s efficacy, safety, psychoactive profile, and impact on quality of life. Financial result releases provide additional context on the company’s cash position, research and development spending, and progress across its clinical programs. For a consolidated view of these developments, this news page aggregates GHRS press releases and related coverage in one place.
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.