Neurizon Therapeutics Limited
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Highlights:
Neurizon® Therapeutics and Elanco Animal Health enter into an exclusive global licensing agreement Provides worldwide rights for Neurizon to utilise Elanco's intellectual property, providing exclusive access to an extensive package of non-clinical studies and manufacturing data and outlines key terms for a future supply agreement for GMP-compliant MonepantelProvides a clear pathway for accelerated global commercialisation of NUZ-001[1] and significantly de-risks future global regulatory approval processesThe license agreement represents the first step in formalising Neurizon's relationship with Elanco, with the next step focused on finalising a supply agreement expected H2 CY 2025Highlights:
Neurizon® Therapeutics and Elanco Animal Health enter into an exclusive global licensing agreement Provides worldwide rights for Neurizon to utilise Elanco's intellectual property, providing exclusive access to an extensive package of non-clinical studies and manufacturing data and outlines key terms for a future supply agreement for GMP-compliant MonepantelProvides a clear pathway for accelerated global commercialisation of NUZ-001[1] and significantly de-risks future global regulatory approval processesThe license agreement represents the first step in formalising Neurizon's relationship with Elanco, with the next step focused on finalising a supply agreement expected H2 CY 2025Highlights:
NUZ-001 and its active metabolite NUZ-001 Sulfone demonstrated significant neuroprotective effects in a zebrafish model of Huntington's diseaseTreatment prevented hallmark developmental and morphological abnormalities, protected against neuronal cell death, restored delayed haemoglobin production, and rescued BDNF expression following Htt protein knockdownNeurizon plans to initiate additional validation studies in mammalian models of Huntington's diseaseThese findings reinforce NUZ-001's potential as a platform therapy targeting core neurodegenerative mechanismsHighlights:
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-001The IND is a comprehensive dossier of information, including animal and human studies, pharmacokinetic analyses, toxicology studies, and manufacturing information for NUZ-001The FDA has a period of 30 days to review the IND applicationNUZ-001 targets TDP-43 protein aggregation, a hallmark of ALS pathology, supported by its demonstrated safety and preliminary efficacy profile in earlier clinical studiesHighlights:
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-001The IND is a comprehensive dossier of information, including animal and human studies, pharmacokinetic analyses, toxicology studies, and manufacturing information for NUZ-001The FDA has a period of 30 days to review the IND applicationNUZ-001 targets TDP-43 protein aggregation, a hallmark of ALS pathology, supported by its demonstrated safety and preliminary efficacy profile in earlier clinical studiesHighlights:
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-001The IND is a comprehensive dossier of information, including animal and human studies, pharmacokinetic analyses, toxicology studies, and manufacturing information for NUZ-001The FDA has a period of 30 days to review the IND applicationNUZ-001 targets TDP-43 protein aggregation, a hallmark of ALS pathology, supported by its demonstrated safety and preliminary efficacy profile in earlier clinical studiesHighlights:
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 ~50% and ~55% respectively, in M337V Motor Neurons in response to a stressorTDP-43 aggregation is a key hallmark pathological feature of ALSTreatment with NUZ-001 and its major metabolite significantly improved electrophysiological dysfunction of TDP-43 mutated M337V Motor Neurons Provides valuable insights into the mechanism of action of NUZ-001 in ALS and strengthens promising efficacy results from the Phase 1 MEND study completed earlier this year in patients with ALSHighlights:
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 ~50% and ~55% respectively, in M337V Motor Neurons in response to a stressorTDP-43 aggregation is a key hallmark pathological feature of ALSTreatment with NUZ-001 and its major metabolite significantly improved electrophysiological dysfunction of TDP-43 mutated M337V Motor Neurons Provides valuable insights into the mechanism of action of NUZ-001 in ALS and strengthens promising efficacy results from the Phase 1 MEND study completed earlier this year in patients with ALSHighlights:
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 regulatory and commercial benefitsPositions Neurizon to advance the development of NUZ-001 for patients facing ALS, a debilitating neurodegenerative disease with limited treatment optionsMELBOURNE, Australia, Nov. 11, 2024 /PRNewswire/ -- Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, is pleased to announce it has received notice of a positive opinion from the European Medicines Agency (EMA) for Orphan Medicinal Product Designation (OMPD) following its application for its lead drug candidate, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The European Commission is scheduled to issue the official decision on the Orphan Designation in December.
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 regulatory and commercial benefitsPositions Neurizon to advance the development of NUZ-001 for patients facing ALS, a debilitating neurodegenerative disease with limited treatment optionsMELBOURNE, Australia, Nov. 11, 2024 /PRNewswire/ -- Neurizon Therapeutics Limited (ASX: NUZ & NUZOA) ("Neurizon" or "the Company"), a clinical-stage biotech company advancing treatments for neurodegenerative diseases, is pleased to announce it has received notice of a positive opinion from the European Medicines Agency (EMA) for Orphan Medicinal Product Designation (OMPD) following its application for its lead drug candidate, NUZ-001, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The European Commission is scheduled to issue the official decision on the Orphan Designation in December.
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