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Neurizon Therapeutics Takes Proactive Steps to Lift FDA Hold on ALS Drug

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Neurizon Therapeutics Takes Proactive Steps to Lift FDA Hold on ALS Drug

The latest update is out from Pharmaust Limited ( (AU:NUZ) ).

Neurizon Therapeutics Limited has initiated steps to lift the clinical hold on its Investigational New Drug application for NUZ-001, following ongoing communication with the US FDA. The company has submitted a formal request for advice on two short-term pharmacokinetic studies, which are expected to generate necessary animal exposure data to meet FDA requirements. These studies, anticipated to be completed in four months, underscore Neurizon’s proactive approach to advancing NUZ-001 as a potential treatment for ALS and other neurodegenerative diseases, aiming for entry into the HEALEY ALS Platform Trial in the second half of 2025.

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, aimed at treating ALS, the most common form of motor neurone disease. Neurizon’s strategy involves accelerating access to effective ALS treatments and exploring broader applications for NUZ-001 in neurodegenerative conditions through international collaborations and rigorous clinical programs.

YTD Price Performance: -37.36%

Average Trading Volume: 5,983

Technical Sentiment Consensus Rating: Buy

Current Market Cap: €31.38M

For detailed information about NUZ stock, go to TipRanks’ Stock Analysis page.

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