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Neurizon Receives FDA Guidance on NUZ-001 IND Application

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Neurizon Receives FDA Guidance on NUZ-001 IND Application

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Pharmaust Limited ( (AU:NUZ) ) has provided an announcement.

Neurizon Therapeutics Limited has received guidance from the FDA regarding its IND application for NUZ-001, which is under clinical hold. The FDA has requested additional animal exposure data to assess systemic exposure adequacy without raising safety concerns from previous studies. Neurizon is working to provide the requested data and assess the impact on its ALS clinical trial timeline, leveraging its regulatory expertise and industry partnerships.

More about Pharmaust Limited

Neurizon Therapeutics Limited is a clinical-stage biotechnology company focused on developing treatments for neurodegenerative diseases. The company is developing NUZ-001, a lead drug candidate for treating ALS, the most common form of motor neuron disease. Neurizon aims to accelerate access to effective ALS treatments and explore broader applications for NUZ-001 in neurodegenerative disorders through international collaborations and rigorous clinical programs.

YTD Price Performance: -22.22%

Average Trading Volume: 5,882

Technical Sentiment Consensus Rating: Buy

Current Market Cap: €38.74M

Find detailed analytics on NUZ stock on TipRanks’ Stock Analysis page.

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