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,...
Neurizon's NUZ-001 Reduces Aggregation of Key ALS Disease Target TDP-43 in Preclinical Study
Highlights: * Positive preclinical results in human in vitro iPSC Motor Neuron models of Amyotrophic Lateral Sclerosis (ALS) * Neurizon's lead drug NUZ-001 and its major active metabolite significantly and dose-dependently prevented the aggregation of TAR DNA-binding protein 43 (TDP-43) by ~...
Neurizon Therapeutics Receives Positive Opinion on Orphan Medicinal Product Designation for NUZ-001 in Europe
Highlights: * Notice of positive opinion received from the European Medicines Agency for Orphan Medicinal Product Designation for NUZ-001 in Amyotrophic Lateral Sclerosis * Orphan Designation offers 10 years of market exclusivity in Europe upon product approval, along with additional regulat...
PharmAust affirms corporate strategy with name change to Neurizon Therapeutics
MELBOURNE, Australia, Oct. 15, 2024 /PRNewswire/ -- Neurizon Therapeutics Limited (ASX: NUZ) ("Neurizon" or "the Company"), a clinical-stage biotech company dedicated to advancing treatments for neurodegenerative diseases, is pleased to announce it has officially changed its name from PharmAust L...