Research analysts covering GH Research.
Recent press releases and 8-K filings for GHRS.
GH Research PLC Presents Positive Clinical Trial Results for GH001
GHRS
New Projects/Investments
- GH Research PLC presented positive results from its GH001-TRD-201, GH001-PPD-203, and GH001-BD-202 clinical trials at the 64th American College of Neuropsychopharmacology (ACNP) annual meeting on January 15, 2026.
- In the Phase 2b Treatment-Resistant Depression (TRD) trial, GH001 led to a -15.5 mean MADRS reduction from baseline on Day 8 compared to placebo, achieving a 57.5% remission rate at Day 8 and a 73% remission rate at 6 months in Open-Label Extension (OLE) completers.
- For patients with Postpartum Depression (PPD), GH001 resulted in a -35.4 mean MADRS reduction from baseline on Day 8, with all patients achieving remission (MADRS total score <=10) and a 56% improvement in maternal functioning.
- Across all three trials (TRD, PPD, and Bipolar II Disorder with a Major Depressive Episode), GH001 was generally well tolerated, with most Treatment-Emergent Adverse Events (TEAEs) being mild or moderate, and no treatment-related serious TEAEs or suicidal intent/behavior reported.
- The median duration of psychoactive effects for GH001 was 11 minutes, and patients were typically discharge-ready within 1 hour post-dose.
6 days ago
GH Research PLC presents positive Phase 2b clinical trial results for GH001 in Treatment-Resistant Depression
GHRS
New Projects/Investments
- GH Research PLC presented positive results from its GH001-TRD-201 clinical trial for Treatment-Resistant Depression (TRD) at the 64th American College of Neuropsychopharmacology (ACNP) annual meeting.
- The trial showed that GH001 led to a significant reduction of 15.5 in mean MADRS score from baseline on Day 8 compared to placebo.
- The remission rate (MADRS total score ≤10) was 57.5% on Day 8 and 73.0% at Month 6 for Open-Label Extension (OLE) completers.
- GH001 also demonstrated significant improvements in global illness severity, anxiety symptoms, and quality of life.
- The treatment was generally well tolerated with no reported flashbacks, suicidal intent, or suicidal behavior.
Jan 13, 2026, 12:15 PM
GH Research PLC to Present Positive Clinical Trial Results for GH001 at ACNP Meeting
GHRS
Product Launch
New Projects/Investments
- GH Research PLC announced it will present positive clinical trial results for its drug candidate GH001 at the 64th American College of Neuropsychopharmacology (ACNP) annual meeting from January 12-15, 2026.
- In a Phase 2b trial for Treatment-Resistant Depression (TRD), GH001 demonstrated a significant reduction in MADRS total score of -15.5 compared to placebo by Day 8, with 57.5% remission at Day 8 and 73.0% remission at 6 months in patients who completed the open-label extension.
- A Phase 2a trial of GH001 in patients with Bipolar II Disorder (BDII) and a Major Depressive Episode (MDE) showed a significant reduction in MADRS total score of -16.8 by Day 8, with no emergence of manic symptoms and a favorable safety profile.
- Across both trials, GH001 was well tolerated with no treatment-related serious adverse events and was not associated with increased suicidal ideation or behavior.
Jan 8, 2026, 12:30 PM
GH Research Announces FDA Lifts Clinical Hold on GH001
GHRS
Product Launch
New Projects/Investments
- GH Research PLC (GHRS) announced on January 5, 2026, that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug Application (IND) for GH001, enabling U.S. subject enrollment.
- The company is targeting Phase 3 initiation for GH001 in 2026 and plans to meet with the FDA to align on the design for the pivotal Phase 3 program.
- GH001, a potential treatment for Treatment-Resistant Depression (TRD), previously demonstrated a -15.5 point placebo-adjusted MADRS reduction on Day 8 (p<0.0001) in its Phase 2b trial.
Jan 5, 2026, 12:20 PM
GH Research Announces FDA Lifts Clinical Hold on GH001
GHRS
New Projects/Investments
- The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on GH Research PLC's Investigational New Drug Application (IND) for GH001, clearing it for U.S. clinical investigation.
- This clearance enables U.S. subject enrollment and positions the company to advance GH001 as a potential ultra-rapid and durable treatment option for Treatment-Resistant Depression (TRD) patients.
- GH Research plans to seek FDA alignment on a global Phase 3 program, with initiation targeted for 2026.
- Previously reported Phase 2b trial highlights for GH001 include meeting the primary endpoint with a -15.5 point placebo-adjusted MADRS reduction on Day 8 and achieving ultra-rapid remission in 57.5% of patients on Day 8.
Jan 5, 2026, 12:00 PM
GH Research to Announce IND Status for GH001
GHRS
New Projects/Investments
Product Launch
- GH Research PLC will provide an update on the status of its Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA).
- The company will also update on its global pivotal Phase 3 program for treatment-resistant depression (TRD).
- This announcement is scheduled for Monday, January 5, 2026, at 7:00 a.m. EST.
- GH001, the lead product candidate, previously met its primary endpoint in a Phase 2b trial, showing a -15.5 point reduction in MADRS from baseline compared to placebo on Day 8.
Jan 2, 2026, 9:07 PM
GH Research to Announce IND Status and Phase 3 Program Update for GH001
GHRS
New Projects/Investments
- GH Research PLC (Nasdaq: GHRS) is scheduled to provide an update on its Investigational New Drug Application (IND) for GH001 with the U.S. FDA.
- The company will also update on its global pivotal Phase 3 program for GH001, which targets treatment-resistant depression (TRD).
- This announcement is scheduled for Monday, January 5, 2026, at 7:00 a.m. EST.
- GH001, a mebufotenin therapy, previously met its primary endpoint in a Phase 2b trial, showing a -15.5 point MADRS reduction from baseline compared to placebo on Day 8.
Jan 2, 2026, 9:01 PM
GH Research PLC to Present Positive GH001 Clinical Trial Results
GHRS
New Projects/Investments
- GH Research PLC announced its acceptance to the Promising Targets Oral Session at the 64th American College of Neuropsychopharmacology (ACNP) annual meeting, where it will present results from its GH001-TRD-201 clinical trial from January 12-15, 2026.
- The Phase 2b multicenter trial assessed GH001 for treatment-resistant depression (TRD), demonstrating a significant improvement in depressive symptoms (MADRS total score) by Day 8 compared to placebo, with a least squares mean difference of −15.5 (P<0.0001).
- In the open-label extension (OLE), 73.0% of patients achieved remission (MADRS total score ≤10).
- At Month 6, patients who completed the OLE showed significant and durable improvements in illness severity (CGI-S decreased by −3.0; P<0.0001), anxiety symptoms (HAM-A decreased by −13.3; P<0.0001), and quality of life (Q-LES-Q-SF increased by 24.8; P<0.0001).
Nov 24, 2025, 2:21 PM
GH Research PLC Reports Q3 2025 Financial Results and Provides Business Updates
GHRS
Earnings
New Projects/Investments
Guidance Update
- GH Research PLC reported cash, cash equivalents and marketable securities of $293.9 million as of September 30, 2025.
- The company's engagement with the FDA on the GH001 Investigational New Drug (IND) complete response is ongoing, with one hold topic remaining after the FDA maintained its clinical hold in July 2025.
- The full dataset from the Phase 2b clinical trial of GH001 in treatment-resistant depression (TRD) reported in July 2025 met its primary endpoint with a -15.5 point reduction in MADRS on Day 8 (p<0.0001), and long-term clinical data from the Open-Label Extension presented in October 2025 confirmed a 73% remission rate at 6 months.
- GH Research PLC expects to initiate its global pivotal program in 2026.
- For the quarter ended September 30, 2025, the company reported a net loss of $14.0 million, or $0.23 loss per share.
Nov 6, 2025, 12:09 PM
GH Research PLC Presents Positive Long-Term Data for GH001 in TRD Clinical Trial
GHRS
New Projects/Investments
- GH Research PLC presented positive long-term data from its GH001-TRD-201 clinical trial for Treatment-Resistant Depression (TRD) at the 38th European College of Neuropsychopharmacology (ECNP) annual meeting on October 13, 2025.
- The trial met its primary endpoint, demonstrating a significant reduction of 15.5 points in the Montgomery-\u00c5sberg Depression Rating Scale (MADRS) from baseline by Day 8 with GH001 compared to placebo.
- GH001 led to a 57.5% remission rate at Day 8 in the double-blind period, and 73.0% of patients who completed the open-label extension (OLE) were in remission at 6 months.
- The treatment was well tolerated over the 6-month OLE, with no treatment-related serious adverse events or instances of suicidal intent or behavior reported.
Oct 14, 2025, 11:00 AM
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