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[{"orgOrder":0,"company":"Nippon Shinyaku","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"EC Grants Orphan Drug Designation to Nippon Shinyaku's viltolarsen (NS-065\/NCNP-01)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Option Care Health","sponsor":"NS Pharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Option Care Health Selected as a Limited Distribution Provider of VILTEPSO\u2122 Injection for Patients with Duchenne Muscular Dystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NS Pharma's VILTEPSO injection Now FDA-Approved in the U.S. for the Treatment of Duchenne Muscular Dystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VILTEPSO (viltolarsen) Injection Long-Term Clinical Trial Data to be Presented at the PPMD 2021 Virtual Annual Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VILTEPSO\u00ae (Viltolarsen) Injection: Long-Term Efficacy and Safety Data Presented at the PPMD 2021 Virtual Annual Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VILTEPSO\u00ae (viltolarsen) injection Interim Long-Term Clinical Trial Data Scheduled for Presentation at the World Muscle Society 2021 Virtual Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VILTEPSO\u00ae (viltolarsen) Injection: Long-Term Efficacy and Safety Data Published in the Journal of Neuromuscular Diseases","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VILTEPSO\u00ae (viltolarsen) Injection Four-Year Clinical Trial Data to be Presented at the World Muscle Society 2022 Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NS Pharma Reports on Results of VILTEPSO\u00ae (viltolarsen) Injection After Four Years of Treatment in Open-Label Extension Trial in Duchenne Muscular Dystrophy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Large molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"NS Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NS Pharma Shares Preliminary Results Of Viltolarsen Phase 3 Trial","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"}]

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            Details:

            Viltepso (viltolarsen), an antisense oligonucleotide, is being investigated in ambulatory boys with Duchenne muscular dystrophy.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 27, 2024

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            Details:

            VILTEPSO® (viltolarsen) injection,is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 24, 2022

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            Details:

            VILTEPSO (viltolarsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 04, 2022

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            Details:

            VILTEPSO (Viltolarsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 31, 2022

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            Details:

            Viltepso (viltolarsen) is an antisense oligonucleotide used to treat Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 17, 2021

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            Details:

            In addition to this Phase 2 open-label extension study, NS Pharma continues to investigate the efficacy and safety of VILTEPSO in the confirmatory Phase 3 RACER53 trial.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 01, 2021

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            Details:

            Phase 2 open-label extension study, NS Pharma continues to investigate the efficacy and safety of VILTEPSO in the confirmatory Phase 3 RACER53 trial. This study was initiated in October 2019 and is currently enrolling patients.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 12, 2021

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            Details:

            Option Care Health has been selected to participate in the limited distribution network of VILTEPSO™ (viltolarsen) for patients with Duchenne Muscular Dystrophy (“DMD”) who are amenable to exon 53 skipping therapy.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: NS Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement September 02, 2020

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            Details:

            U.S. Food & Drug Administration (FDA) has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Viltepso

            Highest Development Status: Approved Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 12, 2020

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            Details:

            The NDA for viltolarsen is also being reviewed under an accelerated approval pathway in the U.S. The clinical study in the US is being conducted by NS Pharma, Inc.

            Lead Product(s): Viltolarsen

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 08, 2020

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