FDA Lifts Clinical Hold on NUZ-001
Highlights: * U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®'s lead investigational therapy for ALS * Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025 * IND supported by robust preclinical safety data and comprehensive manufacturing and ...
2025-10-06 14:06
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Neurizon Files IND Application to Support HEALEY ALS Platform Trial
Highlights: * IND application submission to the U.S. Food and Drug Administration (FDA) is a pivotal step in initiating a Phase 2/3 clinical study for NUZ-001 * The IND is a comprehensive dossier of information, including animal and human studies, pharmacokinetic analyses, toxicology studies,...
2024-12-18 10:59
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