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FDA Lifts Clinical Hold on NUZ-001

U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon’s investigational therapy for ALS, clearing the way for the HEALEY ALS Platform Trial.

By: Rachel Klemovitch

Assistant Editor

The U.S. Food and Drug Administration (FDA) has lifted the clinical hold on Neurizon Therapeutics Limited’s lead investigational drug, NUZ‑001. This decision marks a pivotal regulatory milestone for Neurizon and the ALS community, clearing the way for Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, expected to commence Q4 CY2025. With IND now active, Neurizon anticipates Mass General Hospital (MGH) filing a protocol amendment to their IND for the HEALEY ALS Platform...

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