• FDA provides positive written feedback on Neurizon's strategy to resolve clinical hold for NUZ-001
• Two required preclinical pharmacokinetic studies completed ahead of schedule
• Neurizon to submit Complete Response to FDA in coming weeks to lift clinical hold

Neurizon Therapeutics Limited, a clinical-stage biotech company focused on neurodegenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has provided positive written feedback on the company's strategy to resolve the clinical hold for its lead drug candidate NUZ-001, which is being developed for the treatment of amyotrophic lateral sclerosis (ALS). The FDA has accepted Neurizon's plan to conduct two preclinical pharmacokinetic (PK) studies to address the clinical hold. Neurizon has already completed these PK studies ahead of schedule, with the treatment phase and blood sample analysis successfully completed. The study reports are now being finalized. Neurizon anticipates submitting a Complete Response containing the data from these PK studies to the FDA in the coming weeks as part of the formal hold resolution process. The company remains focused on activating its participation in the HEALEY ALS Platform Trial in Q4 2025. Neurizon's Managing Director and CEO, Dr. Michael Thurn, expressed delight at the FDA's confirmation of the company's strategy and highlighted Neurizon's commitment to advancing NUZ-001 with urgency and scientific precision. The company will continue to provide updates on key regulatory and clinical milestones as it works towards lifting the clinical hold and participating in the HEALEY ALS Platform Trial.

Neurizon remains focused on activating its participation in the HEALEY ALS Platform Trial in Q4 2025. The company anticipates that the clinical hold for NUZ-001 will be lifted in August 2025 following the submission of the Complete Response to the FDA in the coming weeks.