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FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial
Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF) ("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the Sean M. Healey & AMG Center for ALS at Mass General Brigham has received clearance from the US Food and Drug Administration (FDA) to proceed with Neurizon's NUZ-001 regimen in the HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) following co
About this update from Neurizon Therapeutics Limited
[{"type":"text","content":"Highlights:","length":11,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol ","length":111,"tagName":"p"}]},{"val":[{"type":"text","content":"This marks the official entry of NUZ-001 as Regimen I in the HEALEY ALS Platform Trial ","length":86,"tagName":"p"}]},{"val":[{"type":"text","content":"Next steps include obtaining single IRB approval, site initiations and clinical start-up activities ahead of commencement of patient enrollment expected early in 2026","length":166,"tagName":"p"}]},{"val":[{"type":"text","content":"Milestone strengthens Neurizon's pathway toward advancing a potential new treatment for ALS","length":95,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":458,"olType":false},{"type":"text","content":"MELBOURNE, Australia, Dec. 11, 2025 /PRNewswire/ -- Neurizon® Therapeutics Limited (ASX: NUZ & NUZOA; OTCQB: NUZTF) ("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to announce that the Sean M. Healey & AMG Center for ALS at Mass General Brigham has received clearance from the US Food and Drug Administration (FDA) to proceed with Neurizon's NUZ-001 regimen in the HEALEY ALS Platform Trial (ClinicalTrials.gov identifier: NCT04297683) following completion of the FDA's 30-day review. NUZ-001 is officially Regimen I.","length":667,"tagName":"p"},{"type":"text","content":"The FDA's acceptance of the protocol amendment allows the commencement of clinical activities under the Sean M. Healey & AMG Center for ALS Investigational New Drug (IND). It represents another significant regulatory milestone for Neurizon, enabling the Company and the HEALEY ALS Platform Trial team to progress to the next operational phases, including Institutional Review Board (IRB) submissions and approvals, activation of clinical trial sites, and initiation of study start-up activities. The first patients are expected to be enrolled early in 2026.","length":565,"tagName":"p"},{"type":"text","content":"The HEALEY ALS Platform Trial is a multicenter, double-blind, placebo-controlled, adaptive trial for ALS created in partnership with the Network of E...