GH Research PLC Receives FDA Clearance for GH001 Clinical Investigation, Targeting Phase 3 Launch in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
0mins
Should l Buy GHRS?
Source: Globenewswire
- FDA Clearance: GH001's clinical investigation has received FDA clearance, lifting the clinical hold and enabling U.S. subject enrollment, marking a significant advancement for the company in treating treatment-resistant depression (TRD).
- Phase 3 Trial Plans: The company aims to initiate its global Phase 3 trial in 2026, designed to replicate the Phase 2b trial, further validating the efficacy and safety of GH001.
- Significant Clinical Effects: In the Phase 2b trial, GH001 achieved a -15.5 point reduction in MADRS by Day 8, with 57.5% of patients experiencing ultra-rapid remission, highlighting its potential in TRD treatment.
- Good Safety Profile: GH001 demonstrated favorable tolerability in clinical trials, with 99% of patients being discharge-ready within one hour of dosing, indicating its convenience and safety for clinical use.
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Analyst Views on GHRS
Wall Street analysts forecast GHRS stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 15.010
Low
19.00
Averages
28.60
High
35.00
Current: 15.010
Low
19.00
Averages
28.60
High
35.00
About GHRS
GH Research PLC is a clinical-stage biopharmaceutical company. The Company is engaged in offering treatment for psychiatric and neurological disorders. The Company's pipeline includes GH001, GH002 and GH003. The Company focuses on developing its 5- Methoxy-N, N-Dimethyltryptamine, (5-MeO-DMT), therapies for the treatment of patients with Treatment Resistant Depression (TRD). Its product candidate, GH001, is formulated for 5-MeO-DMT administration via an inhalation approach. With GH001, the Company has completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). The GH002 is a 5-MeO-DMT product candidate formulated for administration via an injectable approach. GH002 has completed pre-clinical development to support early clinical trials. The GH003 is a 5-MeO-DMT product candidate formulated for administration via an intranasal administration approach.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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