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FDA Clears Path for Neurizon’s ALS Drug NUZ-001 in Pivotal Trial

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FDA Clears Path for Neurizon’s ALS Drug NUZ-001 in Pivotal Trial

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An announcement from Pharmaust Limited ( (AU:NUZ) ) is now available.

Neurizon Therapeutics Limited announced that the U.S. FDA has lifted the clinical hold on its investigational drug, NUZ-001, marking a significant regulatory milestone for the company and the ALS community. This clearance allows Neurizon to proceed with the Phase 2/3 development of NUZ-001 as part of the HEALEY ALS Platform Trial, expected to start in Q4 2025. The decision is supported by robust preclinical safety data and a comprehensive manufacturing framework, positioning Neurizon for accelerated regulatory pathways and future partnerships. The IND for NUZ-001 not only expedites its development but also streamlines future programs, enhancing the drug’s potential as a therapeutic platform with broad applicability.

The most recent analyst rating on (AU:NUZ) stock is a Buy with a A$0.52 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 ALS, the most common form of motor neurone disease. Neurizon aims to accelerate access to effective ALS treatments and explore broader neurodegenerative applications through international collaborations and rigorous clinical programs.

YTD Price Performance: -14.71%

Average Trading Volume: 508,020

Technical Sentiment Signal: Sell

Current Market Cap: A$77.51M

Learn more about NUZ stock on TipRanks’ Stock Analysis page.

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