Appendix 4C & Quarterly Update
Filed with ASX · · 12 pages · English
• US FDA lifted the clinical hold on NUZ-001 Investigational New Drug (IND) application – a key regulatory inflection point and cleared the path for clinical development of NUZ-001 in the treatment of ALS • Subsequent FDA clearance granted for NUZ-001 to enter the HEALEY ALS Platform Trial, with NUZ-001 officially confirmed as Regimen I following completion of the FDA’s 30-day review of the protoc
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Story so far
Earlier from Neurizon Therapeutics
- Neurizon secures $6million R&D Tax Incentive Rebate
- Neurizon Completes Entitlement Offer
- Global Trademark Protection Secured Across Key Markets
- Regulatory and Development Update
- New Funding Secured for HEALEY ALS Platform Trial
Later from Neurizon Therapeutics
- Appendix 4D - Half-year Financial Report - 31 December 2025
- Neurizon Initiates Dosing in HEALEY ALS Platform Trial
- Neurizon Initiates Dosing of NUZ-001 in HEALEY ALS Platform Trial
- Neurizon announces leadership transition
- NUZ-001 Data Shows Multi-Pathway Protein Clearance
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