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[{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Announces Initiation of New Clinical Trial With Evenamide in Patients With Schizophrenia, Following Approval of Plan By FDA","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Updates On STARS Study FDA Interaction","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 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Evenamide","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Newron Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Newron Reports Exceptional One-year Results of Study 014\/15 With Evenamide in Treatment-resistant Schizophrenia (TRS)","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"}]

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            Details:

            NW3509 (evenamide) is an orally available new chemical entity, specifically blocks voltage-gated sodium channels and is devoid of biological activity at >130 other CNS targets. It is under phase 2 clinical development for the treatment of Treatment-resistant Schizophrenia.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 04, 2024

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            Details:

            NW3509 (evenamide) is an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It is under phase 2 clinical development for the treatment of Schizophrenia.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 29, 2023

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            NW-3509 (evenamide) is an orally available new chemical entity, specifically blocks voltage-gated sodium channels. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 20, 2023

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            NW-3509 (evenamide), an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs). It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 16, 2023

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            NW-3509 (Evenamide), an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs). It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 03, 2023

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            The data presented confirm NW-3509 (evenamide) potential to improve symptoms of psychosis in patients who, despite treatment with various antipsychotics, continue to experience severe symptoms of psychosis and functional disabilities.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 07, 2022

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            Details:

            Under the agreement, Newron will sponsor the study and be responsible for Xadago (safinamide), development and execution, as well as leading on all related regulatory interactions. Newron and Zambon will evenly share the cost of the study.

            Lead Product(s): Safinamide Mesylate

            Therapeutic Area: Neurology Product Name: Xadago

            Highest Development Status: Approved Product Type: Small molecule

            Recipient: Zambon Switzerland

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 12, 2021

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            Details:

            Explanatory study 008 is designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed doses of evenamide (7.5 mg and 15 mg BID) in patients with chronic schizophrenia under treatment with a leading second-generation atypical antipsychotics.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 21, 2021

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            Details:

            All evenamide pre-clinical studies requested by FDA completed and first clinical safety study initiated; on track to initiate evenamide Phase III program in 2021.

            Lead Product(s): Evenamide

            Therapeutic Area: Psychiatry/Psychology Product Name: NW-3509

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 11, 2020

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            Details:

            Results from STRIDE 3 short-term treatment of dry eye disease, along with the positive data from the previous clinical trials of EYSUVIS served as the basis for Kala’s NDA resubmission package.

            Lead Product(s): Sarizotan

            Therapeutic Area: Neurology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 04, 2020

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