Neurizon Therapeutics Submit Formal Response to US FDA for Investigational New Drug Application; Shares Up 19%

MT Newswires Live

2025/07/25

Neurizon Therapeutics (ASX:NUZ) submitted a formal response to the US Food and Drug Administration (FDA) regarding the clinical hold on its investigational new drug application for NUZ-001, its lead therapy for amyotrophic lateral sclerosis, according to a Friday filing with the Australian bourse.

The response includes 28-day pharmacokinetic data from studies in rats and dogs to address the FDA's request for more comprehensive animal exposure data to support the safety margins of NUZ-001 and its primary sulfone metabolite, the filing said.

The review is now underway, and the company expects to receive formal feedback within 30 calendar days, per the filing.

Shares rose 19% in morning trade on Friday.

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