GH Research PLC Surges on FDA Clearance for GH001
GH Research PLC shares surged by 47.89% in pre-market trading, reaching a 20-day high, following positive developments regarding its drug GH001.
The significant price movement is attributed to the FDA clearance for GH001's clinical investigation, which allows for U.S. subject enrollment and marks a crucial step towards the planned Phase 3 trial in 2026. This news has heightened investor confidence in the company's ability to address treatment-resistant depression (TRD), especially given the promising results from the Phase 2b trial where GH001 demonstrated a 15.5-point reduction in MADRS scores.
As the company prepares for its upcoming Phase 3 trial, the positive market reaction reflects strong anticipation for GH001's potential impact on TRD treatment, which could lead to substantial market opportunities and revenue growth for GH Research.
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- 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.










