FDA review timeline extended for NUZ-001 IND clinical hold

Australia’s Neurizon Therapeutics (ASK: NUZ) saw its shares rise 10% to A$0.16 today. after it revealed that it has been informed by the US 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, the company’s lead investigational therapy for amyotrophic lateral sclerosis (ALS), is now expected by October 3, 2025.

The FDA’s standard statutory review period for CHCRs is within 30 calendar days, said Neurizon, noting that 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, most recently by Coya Therapeutics, whose IND acceptance for COYA-302 for treating ALS was also deferred due to internal FDA workload pressures.