Neurizon Therapeutics Limited (ASX: NUZ), a clinical-stage biotech company dedicated to advancing innovative treatments for neurodegenerative diseases, has announced that the U.S. Food and Drug Administration (FDA) has extended the review timeline for its Clinical Hold Complete Response (CHCR) to the Investigational New Drug (IND) application for NUZ-001. NUZ-001 is the company’s lead investigational therapy targeting amyotrophic lateral sclerosis (ALS). The FDA’s decision is now anticipated by October 3, 2025.
The FDA’s standard review period for CHCRs is typically 30 calendar days. Neurizon clarified that the delay is not related to the quality or completeness of their submission. Rather, it is attributed to broader capacity issues within the FDA stemming from agency-wide restructuring and staffing reductions resulting from recent administrative reforms. The company noted that similar delays have been experienced by other ALS programs, including Coya Therapeutics’ COYA-302 IND acceptance.
Dr. Michael Thurn, Managing Director and CEO of Neurizon, expressed disappointment but reaffirmed confidence in NUZ-001’s potential as a transformative therapy for ALS. He stated the company is committed to exploring all options to accelerate the review process. Neurizon is actively engaging with U.S. Key Opinion Leaders (KOLs) and patient advocacy groups to advocate for an expedited review, emphasising the urgent need for effective ALS treatments.
Neurizon remains dedicated to delivering innovative treatments for ALS and other neurodegenerative diseases. The company will provide timely updates as it receives further feedback and progresses NUZ-001 toward regulatory approval and patient access. Neurizon Therapeutics Limited (ASX: NUZ) is developing its lead drug candidate, NUZ-001, for the treatment of ALS, which is the most common form of motor neurone disease.