FDA lifts clinical hold on GH001, clearing path for global Phase 3 in 2026

GH Research PLC (GHRS) — GH Research announced the FDA lifted the clinical hold on its Investigational New Drug application for GH001, its inhaled 5-MeO-DMT candidate for treatment-resistant depression, allowing U.S. patient enrollment to proceed.

The resolution — following months addressing IND hold topics with no findings of respiratory toxicity — clears the way for a planned global pivotal Phase 3 program in 2026. GH Research held roughly $294 million in cash as of September 30, 2025, and its Phase 2b trial had shown a 73% six-month remission rate.

Source: globenewswire.com

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