Categories: Health

GH Research to Announce IND Status for GH001

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 PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.

About GH001

Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.

Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com

GlobeNews Wire

Recent Posts

ITM Announces Phase 3 COMPETE Patient-Reported Quality of Life Data with n.c.a. Lu-edotreotide (ITM-11) vs. Everolimus at ASCO 2026

Exploratory analysis showed favorable patient-reported quality of life outcomes and delayed time to deterioration in…

5 hours ago

ImPact Biotech Presents Updated Data from Phase 1 Trial of Padeliporfin VTP in LA-PDAC and Phase 3 ENLIGHTED Trial in LG-UTUC at ASCO 2026

– Updated data across two dose levels of 200 mW/cm and 400 mW/cm in LA-PDAC…

5 hours ago

Fobi AI Provides Corporate Update Regarding FFCTO Revocation Process and Q3 Interim Filings

May 29, 2026 21:18 ET  | Source: Fobi AI Inc. VANCOUVER, BC, May 29, 2026…

13 hours ago

Crypto News Today: AlphaPepe Presale Stage 17 Nears Sell Out While XRP Price Prediction Eyes $7.00

MONACO, May 29, 2026 (GLOBE NEWSWIRE) -- Crypto news today is turning toward AlphaPepe as…

13 hours ago