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FDA/Panel Decisions

Why GH Research Is Rising In Pre-market?

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us

GH Research PLC (GHRS) announced the FDA has lifted the clinical hold on its Investigational New Drug Application for GH001. GH Research said the clearance enables U.S. subject enrollment and progresses the company toward alignment of its development across major jurisdictions.

Velichka Valcheva, CEO, said" "We continue to expect initiation of our global pivotal program in 2026. We look forward to meeting with the FDA to align on the design for the pivotal Phase 3 program."

In pre-market trading on NasdaqGM, GH Research shares are up 42% to $18.81.

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