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GH Research PLC, a clinical-stage biopharmaceutical company, engages in developing various therapies for the treatment of psychiatric and neurological disorders. The company focuses on developing 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) therapies for the treatment of patients with treatment-resistant depression (TRD). Its lead program is GH001, an inhalable 5-MeO-DMT product candidate that has completed two Phase 1 clinical trials and Phase 1/2 clinical trial in patients with TRD. The company also develops GH002, an injectable 5-MeO-DMT product candidate; and GH003, an intranasal 5-MeO-DMT product candidate, which are in preclinical development trials with a focus on psychiatric and neurological disorders. GH Research PLC was incorporated in 2018 and is based in Dublin, Ireland.

GH Research PLC

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GH001 CLEARED BY FDA FOR U.S. CLINICAL INVESTIGATION, ENABLING U.S. SUBJECT ENROLLMENT COMPANY TO SEEK FDA ALIGNMENT ON GLOBAL PHASE 3 PROGRAM REPLICATING PHASE 2B DESIGN PHASE 3 INITIATION TARGETED FOR 2026 DUBLIN, JAN. 05, 2026 (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 THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS LIFTED THE CLINICAL HOLD ON ITS INVESTIGATIONAL NEW DRUG APPLICATION (IND) FOR GH001. THIS CLEARANCE ENABLES U.S. SUBJECT ENROLLMENT AND PROGRESSES THE COMPANY TOWARD ALIGNMENT OF ITS DEVELOPMENT ACROSS MAJOR JURISDICTIONS.

GH RESEARCH ANNOUNCES FDA LIFTS CLINICAL HOLD ON GH001, CLEARING PATH FOR GLOBAL PHASE 3 INITIATION IN 2026

DUBLIN, JAN. 02, 2026 (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 THAT IT 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) AND ITS GLOBAL PIVOTAL PHASE 3 PROGRAM IN TREATMENT-RESISTANT DEPRESSION (TRD) ON MONDAY, JANUARY 5, 2026, AT 7.00 A.M. EST. ABOUT GH RESEARCH PLC GH RESEARCH PLC IS A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY DEDICATED TO TRANSFORMING THE LIVES OF PATIENTS BY DEVELOPING A PRACTICE-CHANGING TREATMENT IN DEPRESSION.

GH RESEARCH TO ANNOUNCE IND STATUS FOR GH001

ENGAGEMENT WITH FDA ON GH001 IND COMPLETE RESPONSE ONGOING FULL DATASET FROM THE PHASE 2B CLINICAL TRIAL OF GH001 IN TRD REPORTED IN JULY 2025 LONG-TERM CLINICAL DATA ON SAFETY AND EFFICACY FROM OPEN-LABEL EXTENSION PRESENTED AT ECNP IN OCTOBER 2025 CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES OF $293.9 MILLION AS OF SEPTEMBER 30, 2025 DUBLIN, NOV. 06, 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 QUARTER ENDED SEPTEMBER 30, 2025, AND PROVIDED UPDATES ON ITS BUSINESS. BUSINESS UPDATES GH001 UPDATE IN JULY 2025, WE ANNOUNCED THAT WE RECEIVED A COMMUNICATION FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) RELATING TO OUR COMPLETE RESPONSE TO THE CLINICAL HOLD OF OUR INVESTIGATIONAL NEW DRUG APPLICATION (IND) FOR GH001, WITH ONLY ONE HOLD TOPIC REMAINING.

GH RESEARCH REPORTS THIRD QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES

DUBLIN, OCT. 09, 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 NOVEL THERAPIES SYMPOSIUM PRESENTATION AT THE 38TH ANNUAL EUROPEAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY CONGRESS (ECNP) IN AMSTERDAM, THE NETHERLANDS FROM OCTOBER 11  14, WHERE PROFESSOR WIESAW J. CUBAA, MD, PHD, DEPARTMENT OF PSYCHIATRY, FACULTY OF MEDICINE, MEDICAL UNIVERSITY OF GDASK, WILL PRESENT LONG-TERM CLINICAL DATA ON THE SAFETY AND EFFICACY FROM THE OPEN LABEL EXTENSION (OLE) OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B CLINICAL TRIAL WITH GH001 IN PATIENTS WITH TREATMENT-RESISTANT DEPRESSION (TRD) (GH001-TRD-201).

GH RESEARCH ANNOUNCES NOVEL THERAPIES SYMPOSIUM PRESENTATION AND POSTERS AT THE 2025 ECNP CONGRESS

GLOBAL PIVOTAL PROGRAM INITIATION ON TRACK FOR 2026 ENGAGEMENT WITH FDA ON GH001 IND COMPLETE RESPONSE ONGOING THE FULLY COMPLETED OPEN-LABEL EXTENSION ANALYSIS CONFIRMS A 73% REMISSION RATE AT 6 MONTHS WITH INFREQUENT TREATMENT VISITS AND NO PSYCHOTHERAPY TREATMENT WAS WELL TOLERATED AND NO TREATMENT RELATED SERIOUS ADVERSE EVENTS WERE REPORTED. THERE WAS NO EVIDENCE OF TREATMENT-EMERGENT SUICIDAL IDEATION OR BEHAVIOR CASH, CASH EQUIVALENTS AND MARKETABLE SECURITIES OF $308.7 MILLION AS OF JUNE 30, 2025 DUBLIN, AUG. 07, 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 QUARTER ENDED JUNE 30, 2025, AND PROVIDED UPDATES ON ITS BUSINESS.

GH RESEARCH REPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES

DUBLIN, JULY 23, 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 PROVIDED UPDATES ON ITS BUSINESS AND KEY UPCOMING MILESTONES.

GH RESEARCH ANNOUNCES GLOBAL PIVOTAL PROGRAM PLANS AND FURTHER DEVELOPMENT UPDATES

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).

GH RESEARCH SUBMITS COMPLETE IND HOLD RESPONSE TO FDA AHEAD OF SCHEDULE

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, UNIVERSITY OF PENNSYLVANIA WILL PRESENT CLINICAL DATA FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B CLINICAL TRIAL WITH GH001 IN PATIENTS WITH TREATMENT-RESISTANT DEPRESSION (TRD) (GH001-TRD-201).

GH RESEARCH ANNOUNCES ACCEPTANCE OF PHARMACEUTICAL PIPELINE PRESENTATION AND LATE-BREAKING POSTERS AT THE AMERICAN SOCIETY OF CLINICAL PSYCHOPHARMACOLOGY 2025 ANNUAL MEETING

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 DEPRESSION, TODAY REPORTED FINANCIAL RESULTS FOR THE QUARTER ENDED MARCH 31, 2025, AND PROVIDED UPDATES ON ITS BUSINESS.

GH RESEARCH REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES

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 2025 PHASE 1 CLINICAL TRIAL TO EVALUATE PROPRIETARY AEROSOL DELIVERY DEVICE IN HEALTHY VOLUNTEERS IS ONGOING IN THE UK FULL RESPONSE TO THE IND HOLD ON TRACK FOR SUBMISSION IN MID-2025 CASH, CASH EQUIVALENTS, OTHER FINANCIAL ASSETS AND MARKETABLE SECURITIES OF $182.6 MILLION AS OF DECEMBER 31, 2024 NET CASH PROCEEDS OF AN ADDITIONAL $139.8 MILLION FROM PUBLIC OFFERING RECEIVED IN FEBRUARY 2025 DUBLIN, 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 INHALABLE MEBUFOTENIN PRODUCT CANDIDATE, IS CURRENTLY BEING INVESTIGATED IN A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL IN APPROXIMATELY 80 PATIENTS WITH TREATMENT-RESISTANT DEPRESSION (TRD) (GH001-TRD-201).

GH RESEARCH REPORTS FULL YEAR 2024 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATES

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 RESEARCH PLC. THE OFFERING IS EXPECTED TO CLOSE ON FEBRUARY 6, 2025, SUBJECT TO CUSTOMARY CLOSING CONDITIONS. IN ADDITION, GH RESEARCH PLC HAS GRANTED THE 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.

GH Research PLC

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