The US FDA has informed Neurizon Therapeutics (ASX:NUZ) that a decision on its Clinical Hold Complete Response for the company's lead investigational therapy NUZ-001 is now not expected until 3 October 2025.
Neurizon is developing NUZ-001 for amyotrophic lateral sclerosis (ALS).
Under normal circumstances, the FDA has 30 days to complete its review. Neurizon said the delay is related to broader strains within the FDA, where restructuring and staffing reductions under recent administrative reforms have slowed review cycles. Other companies working in ALS, including Coya Therapeutics with its program COYA-302, have faced similar setbacks in recent months.
“While this delay is extremely disappointing — particularly given the straightforward nature of the information provided in our response — we remain confident in the potential of NUZ-001 as a transformative therapy for ALS,” said Dr. Michael Thurn, Managing Director and CEO.
Mr Thurn noted that Neurizon is working on multiple fronts to ensure momentum in the development of NUZ-001 is not lost. The company is engaging with US key opinion leaders and patient advocacy groups to press for an expedited review, highlighting the urgent and unmet medical need in ALS. “Our mission remains unchanged,” he added. “We are here to deliver hope and innovative solutions to patients and families living with neurodegenerative diseases, with diligence, transparency, and unwavering focus.”
The setback also reflects a broader industry trend. The FDA itself has acknowledged persistent resourcing challenges and growing backlogs, with timelines across the sector stretching beyond historical norms.