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Neurizon Advances ALS Drug with FDA Clinical Hold Response Submitted
9:32am on Friday 25th of July, 2025 AEST
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Biotechnology
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Neurizon Advances ALS Drug with FDA Clinical Hold Response Submitted
9:32am on Friday 25th of July, 2025 AEST
Key Points
Formal FDA response submitted addressing clinical hold on NUZ-001
New bridging pharmacokinetic data from 28-day rat and dog studies included
Demonstrated over 10-fold safety margins for NUZ-001 and metabolite
FDA review underway with feedback expected within 30 days
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