Neurizon Completes Manufacturing Three Registration Batches of Drug Candidate to Treat Neurodegenerative Disease; Shares Fall 5%

MT Newswires Live

Dec 04, 2025

Neurizon Therapeutics (ASX:NUZ) has completed the manufacturing of three planned registration batches of its NUZ-001 tablets for the treatment of Amyotrophic Lateral Sclerosis (ALS), according to a Thursday filing with the Australian bourse.

The company can now pursue a Rolling Review of the New Drug Application (NDA), allowing the US Food and Drug Administration to review chemistry, manufacturing, and controls details before the full NDA submission, the filing said.

The batches have been placed on both long-term and accelerated stability programs to establish product shelf-life, the filing added.

Neurizon said it is on track to start patient enrolment in the HEALEY ALS platform trial in the first quarter of 2026, the company said.

Shares of the company fell 5% in recent Thursday trade.

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