GH Research (GHRS) FDA Lifts Clinical Hold on GH001, Shares Surge 42%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
0mins
Source: NASDAQ.COM
- Clinical Hold Lifted: GH Research PLC announced that the FDA has lifted the clinical hold on its Investigational New Drug Application for GH001, enabling U.S. subject enrollment and advancing the company's development alignment across major jurisdictions.
- Global Program Initiation Expected: CEO Velichka Valcheva stated that the company anticipates initiating its global pivotal program in 2026, which will not only accelerate product development but also enhance the company's position in the competitive biopharmaceutical market.
- Positive Stock Reaction: In pre-market trading on NasdaqGM, GH Research shares surged 42% to $18.81, reflecting strong market optimism regarding the company's future prospects following the FDA's announcement.
- Follow-up Meeting with FDA: The company looks forward to meeting with the FDA to align on the design for the pivotal Phase 3 program, which will lay the groundwork for future clinical trials and potentially expedite the product's market entry.
Analyst Views on GHRS
Wall Street analysts forecast GHRS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GHRS is 28.60 USD with a low forecast of 19.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 16.600
Low
19.00
Averages
28.60
High
35.00
Current: 16.600
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.
