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Pharmaust Limited ( (AU:NUZ) ) has shared an announcement.
Neurizon Therapeutics Limited has submitted a formal response to the FDA to address the clinical hold on its investigational drug, NUZ-001, intended for ALS treatment. This submission includes new pharmacokinetic data from animal studies, demonstrating significant safety margins and supporting dose selection for further clinical evaluation. The FDA’s review is expected to conclude within 30 days, and Neurizon aims to participate in the HEALEY ALS Platform Trial by Q4 2025, contingent upon regulatory clearance. This development marks a critical step in advancing NUZ-001 as a potential first-in-class therapy for ALS, reflecting Neurizon’s commitment to delivering meaningful treatment options ahead of schedule.
The most recent analyst rating on (AU:NUZ) stock is a Buy with a A$0.42 price target. To see the full list of analyst forecasts on Pharmaust Limited stock, see the AU:NUZ Stock Forecast page.
More about Pharmaust Limited
Neurizon Therapeutics Limited is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases. The company is advancing its lead drug candidate, NUZ-001, for the treatment of amyotrophic lateral sclerosis (ALS), the most common form of motor neurone disease. Neurizon aims to accelerate access to effective ALS treatments and explore broader applications for NUZ-001 in neurodegenerative conditions through international collaborations and rigorous clinical programs.
Average Trading Volume: 338,432
Technical Sentiment Signal: Hold
Current Market Cap: A$76.31M
For an in-depth examination of NUZ stock, go to TipRanks’ Overview page.