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 (GHRS) reported significant progress in its clinical trials and financial results for 2024. The company's Phase 2b trial of GH001 for treatment-resistant depression met its primary endpoint, showing a significant placebo-adjusted MADRS reduction of -15.5 on Day 8. The trial achieved a 57.5% remission rate compared to 0% in placebo group.
The company's financial position remains strong with $182.6 million in cash and equivalents as of December 31, 2024, plus additional net proceeds of $139.8 million from a February 2025 public offering. R&D expenses increased to $35.0 million in 2024 from $29.8 million in 2023. Net loss widened to $39.0 million ($0.75 per share) compared to $35.6 million ($0.68 per share) in 2023.
GH Research PLC (Nasdaq: GHRS) has announced the pricing of its public offering of 10,000,000 ordinary shares at $15.00 per share, aiming to raise approximately $150 million in gross proceeds. The offering is expected to close on February 6, 2025.
The company has granted underwriters a 30-day option to purchase up to an additional 1,500,000 ordinary shares at the public offering price, less underwriting discounts and commissions. The joint book-running managers for the offering are Cantor, Stifel, and RBC Capital Markets, with Canaccord Genuity and Citizens JMP acting as co-lead managers.
GH Research PLC (Nasdaq: GHRS) has announced a proposed public offering of $150 million of ordinary shares in the United States. The company plans to grant underwriters an option to purchase up to an additional $22.5 million of ordinary shares at the public offering price, less underwriting discounts and commissions.
The offering will be managed by joint book-running managers Cantor, Stifel, and RBC Capital Markets, with Canaccord Genuity and Citizens JMP acting as co-lead managers. The offering will be conducted through a prospectus supplement and accompanying prospectus, with the registration statement already declared effective by the SEC on March 17, 2023.
GH Research (NASDAQ: GHRS) announced successful Phase 2b trial results for GH001, their inhalable mebufotenin product candidate for treatment-resistant depression (TRD). The trial's primary endpoint was met, showing a significant -15.5 point placebo-adjusted MADRS reduction in depression scores on Day 8 (p0.0001).The trial involved 81 TRD patients, with 40 receiving GH001 and 41 receiving placebo. Key achievements include a 57.5% remission rate in the GH001 group compared to 0% in placebo. The drug demonstrated strong safety profiles with no serious adverse events reported. In the ongoing open-label extension (OLE), 77.8% of completers maintained remission at 6 months, with most patients requiring only 1-4 treatments over this period.
GH Research PLC (Nasdaq: GHRS) has announced a conference call and webcast scheduled for February 3, 2025, at 8:00 a.m. EST. The purpose is to provide updates on data from their Phase 2b trial of GH001 in treatment-resistant depression (TRD). The trial is characterized as randomized, double-blind, and placebo-controlled. The event will be accessible through advance registration and will be available on the company's website under the Events & Presentations section.
GH Research (GHRS) announced successful results from two Phase 2a proof-of-concept trials for GH001. The first trial in postpartum depression (PPD) showed a significant MADRS score reduction of -35.4 points with 100% of patients achieving remission by Day 8. The second trial in bipolar II disorder (BDII) demonstrated a MADRS reduction of -16.8 points with 33.3% of patients in remission by Day 8.
The company completed FDA-requested inhalation toxicology studies in dogs showing no respiratory tract findings, supporting their position that previous findings were rat-specific. GHRS plans to submit a full response to the FDA's IND hold in mid-2025. Their Phase 2b trial in treatment-resistant depression remains on track with top-line data expected in Q1 2025.
The company's financial position remains strong with $182.6 million in cash and equivalents as of December 31, 2024, compared to $222.7 million the previous year.
GH Research has completed enrollment for its Phase 2b trial of GH001 (inhaled mebufotenin) in treatment-resistant depression, with top-line data expected by Q1 2025. The company reported $193.8 million in cash and equivalents as of September 30, 2024, down from $222.7 million at end-2023. Q3 2024 saw increased R&D expenses of $8.4 million (vs $7.1M in Q3 2023) and G&A expenses of $4.2 million (vs $2.6M in Q3 2023), resulting in a net loss of $12.1 million ($0.23 per share). The FDA clinical hold on GH001's IND continues, with ongoing nonclinical studies addressing inhalation toxicology concerns.
GH Research PLC (Nasdaq: GHRS) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Phase 2b trial of GH001 for treatment-resistant depression (TRD) on track for completion in Q3 2024.
2. Phase 1 trial for proprietary aerosol delivery device approved in the UK and recruiting.
3. Cash position of $204.5 million as of June 30, 2024.
4. R&D expenses increased to $9.8 million in Q2 2024 from $7.2 million in Q2 2023.
5. Net loss of $10.4 million ($0.20 per share) in Q2 2024 compared to $7.7 million ($0.15 per share) in Q2 2023.
6. FDA clinical hold on GH001 IND continues, with ongoing nonclinical studies to address inhalation toxicology concerns.