Workflow
GH Research PLC(GHRS)
icon
Search documents
GH Research Submits Complete IND Hold Response to FDA Ahead of Schedule
Globenewswire· 2025-06-20 17:00
DUBLIN, June 20, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application (IND) for GH001 to the U.S. Food and Drug Administration (FDA). “We are thrilled to have submitted our response to the FDA ahead of sche ...
GH Research Announces Acceptance of Pharmaceutical Pipeline Presentation and Late-Breaking Posters at the American Society of Clinical Psychopharmacology 2025 Annual Meeting
GlobeNewswire News Room· 2025-05-15 11:00
DUBLIN, May 15, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced the acceptance of a Pharmaceutical Pipeline Presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP) in Arizona, United States from May 27 – 30, where Professor Michael E. Thase, MD, Professor of Psychiatry, Perelman School of Medicine, Uni ...
GH Research Reports First Quarter 2025 Financial Results and Provides Business Updates
Globenewswire· 2025-05-08 11:00
Primary endpoint met in Phase 2b trial with GH001 in TRD demonstrating -15.5 Point placebo-adjusted MADRS reductionFull response to the IND hold on track for submission in mid-2025Cash, cash equivalents, other financial assets and marketable securities of $315.3 million as of March 31, 2025 DUBLIN, May 08, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depressio ...
What Makes GH Research (GHRS) a New Buy Stock
ZACKS· 2025-05-05 17:00
Investors might want to bet on GH Research PLC (GHRS) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual invest ...
GH Research PLC(GHRS) - 2024 Q4 - Annual Report
2025-02-27 12:32
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 19 ...
GH Research PLC(GHRS) - 2024 Q4 - Annual Report
2025-02-27 12:08
Exhibit 99.1 GH Research Reports Full Year 2024 Financial Results and Provides Business Updates DUBLIN, Ireland, Feb 27, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today reported financial results for the year ended December 31, 2024, and provided updates on its business. Business Updates GH001 in Patients with TRD GH001, our proprietary inhalabl ...
GH Research Reports Full Year 2024 Financial Results and Provides Business Updates
Globenewswire· 2025-02-27 12:00
Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for completion of last patient visit in the open-label extension in Q1 2025Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UKFull response to the IND hold on track for submission in mid-2025Cash, cash equivalents, other financial assets and marketable securities of $182.6 million as of December 31, 2024Net cash proceeds of an additional $139.8 million from ...
GHRS Stock Rallies 55% in a Week: Here's What You Should Know
ZACKS· 2025-02-06 16:26
Core Viewpoint - GH Research PLC's shares have surged 54.8% following the announcement of positive results from a mid-stage study of its investigational inhalable mebufotenin product candidate, GH001, for treatment-resistant depression (TRD) [1] Group 1: Clinical Study Results - In the phase IIb TRD study, patients treated with GH001 experienced a significant 15.2-point reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) score by Day 8, while the placebo group showed a slight increase of 0.3 points [2] - The remission rate for patients receiving GH001 was 57.5% on Day 8, compared to 0% in the placebo group, with a 91.7% remission rate at six months for those who achieved remission on Day 8 [3] - GH001 met all secondary endpoints in the phase IIb study with clinically and statistically significant improvements on Day 8 compared to placebo [4] Group 2: Treatment Implications - GH001 offers a rapid and substantial effect for TRD patients, who often find existing therapies ineffective, potentially revolutionizing clinical practice with infrequent, short clinic visits lasting just 1-3 hours [5] - The treatment was well tolerated, with no serious adverse events reported on Day 8, and all treatment-emergent adverse events were mild or moderate [6][8] Group 3: Ongoing Development - GH Research is also evaluating GH001 for bipolar II disorder and postpartum depression in separate mid-stage proof-of-concept studies, having met primary endpoints in both studies [9] - The company's second mebufotenin product candidate, GH002, is in early-stage development as an intravenous injection for psychiatric and neurological disorders [10]
GH Research Announces Pricing of $150 Million Public Offering
Newsfilter· 2025-02-05 01:52
DUBLIN, Feb. 05, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced the pricing of its previously announced underwritten public offering in the United States of 10,000,000 ordinary shares at a public offering price of $15.00 per share for total gross proceeds of approximately $150 million. All of the ordinary shares are being offered by GH ...
GH Research Announces Proposed Public Offering
Globenewswire· 2025-02-03 21:03
DUBLIN, Feb. 03, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced the commencement of an underwritten public offering in the United States of $150 million of ordinary shares. All of the ordinary shares are to be offered by GH Research PLC. In addition, GH Research PLC intends to grant the underwriters an option to purchase up to an add ...