• FDA extends decision timeline on NUZ-001 IND clinical hold response
• Delay due to broader FDA capacity and staffing challenges, not submission quality
• Neurizon committed to accelerating NUZ-001 development and engaging with key stakeholders

Neurizon Therapeutics Limited (ASX: NUZ & NUZOA), a clinical-stage biotech company focused on neurodegenerative diseases, has been informed by the U.S. Food and Drug Administration (FDA) that the decision on its Clinical Hold Complete Response (CHCR) to the Investigational New Drug (IND) application for NUZ-001, its lead therapy for amyotrophic lateral sclerosis (ALS), is now expected by 3 October, 2025. The FDA's standard statutory review period for CHCRs is within 30 calendar days. This delay is not a reflection on the quality or completeness of Neurizon's submission but rather the result of broader strain in the FDA's capacity caused by agency-wide restructuring and staffing reductions under recent administrative reforms, impacting the FDA's ability to maintain timely review cycles. Similar delays have been experienced by other ALS programs. Neurizon remains committed to delivering innovative treatments for ALS and other neurodegenerative diseases, and is actively engaging with leading U.S. Key Opinion Leaders (KOLs) and patient advocacy groups to advocate for an expedited review, recognizing the critical and urgent unmet need in ALS.

Neurizon remains committed to delivering innovative treatments for ALS and other neurodegenerative diseases. The company will continue to provide timely updates as it receives further feedback and takes the necessary steps to advance NUZ-001 toward regulatory approval and patient access.