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    [{"orgOrder":0,"company":"Lysogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lysogene Receives FDA Fast Track Designation for LYS-SAF302 Gene Therapy in MPS IIIA","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Lysogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lysogene Announces Important Updates on AAVance Phase 2\/3 Clinical Trial with LYS-SAF302 in MPS IIIA","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Sarepta Therapeutics","sponsor":"Lysogene","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lysogene Announces Termination of License Agreement With Sarepta for LYS-SAF302 Program, Regaining Global Commercial Rights","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Lysogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lysogene Provides Update on Efficacy, Safety and Timelines of the AAVance phase 2\/3 Clinical Trial With Gene Therapy LYS-SAF302 For the Treatment of MPSIIIA","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Lysogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lysogene Provides Clinical Update on AAVance Phase 2\/3 Clinical Trial with Gene Therapy LYS-SAF302 for the Treatment of MPS IIIA at the 25th Annual ASGCT Meeting","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Lysogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lysogene Provides Updates and Topline Results from Phase 2\/3 AAVance Gene Therapy Clinical Study","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Lysogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lysogene to Provide Updates and Topline Results from Phase 2\/3 AAVance Gene Therapy Clinical Study and Host Webcast on Wednesday, November 23, 2022","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II\/ Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase II\/ Phase III"}]

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    Olenasufligene Relduparvovec

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              Lysogene

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              Lysogene Provides Updates and Topline Results from Phase 2/3 AAVance Gene Therapy Clinical Study

              Details:

              LYS-SAF302 (olenasufligene relduparvovec) is a novel gene therapy in Phase 2/3 development for the treatment of MPS IIIA, or Sanfilippo syndrome type A. LYS-SAF302 delivers a functional copy of the human SGSH gene directly to brain cells using the AAV carrier.

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: LYS-SAF302

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 18, 2022

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              Lysogene

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              Lysogene to Provide Updates and Topline Results from Phase 2/3 AAVance Gene Therapy Clinical Study and Host Webcast on Wednesday, November 23, 2022

              Details:

              LYS-SAF302 (olenasufligene relduparvovec) delivers a working copy of the human SGSH gene directly to the brain through intra-cerebral injection. Mutations to the SGSH gene are responsible for the developmental, physical and behavioral symptoms of the disease.

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: LYS-SAF302

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 18, 2022

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              Lysogene

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              Lysogene Provides Clinical Update on AAVance Phase 2/3 Clinical Trial with Gene Therapy LYS-SAF302 for the Treatment of MPS IIIA at the 25th Annual ASGCT Meeting

              Details:

              Preliminary results evaluating LYS-SAF302 (olenasufligene relduparvovec) in patients with Sanfilippo syndrome type A who have been followed for at least two years demonstrated improvement, stabilization, or slowing down of decline in cognitive-developmental age.

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: LYS-SAF302

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 18, 2022

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              Lysogene

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              Lysogene Provides Update on Efficacy, Safety and Timelines of the AAVance phase 2/3 Clinical Trial With Gene Therapy LYS-SAF302 For the Treatment of MPSIIIA

              Details:

              AAVance trial evaluates, effectiveness of a one-time intracerebral delivery of a recombinant adeno-associated virus vector rh.10 carrying the N-sulfoglucosamine sulfohydrolase gene LYS-SAF302 (olenasufligene relduparvovec) in children with MPS IIIA.

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: LYS-SAF302

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 24, 2022

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              Sarepta Therapeutics

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              Lysogene Announces Termination of License Agreement With Sarepta for LYS-SAF302 Program, Regaining Global Commercial Rights

              Details:

              The termination of the agreement will enable Lysogene to regain development and commercialization rights for LYS-SAF302 in the US and other non-EU territories as well as the responsibility for global commercial supply of LYS-SAF302.

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: LYS-SAF302

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Lysogene

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Termination January 13, 2022

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              Lysogene

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              Lysogene Announces Important Updates on AAVance Phase 2/3 Clinical Trial with LYS-SAF302 in MPS IIIA

              Details:

              Following discussions with the U.S. FDA, a clinical hold was issued for the clinical trial AAVance, a global Phase 2/3 clinical trial of LYS-SAF302, a gene therapy for the treatment of Mucopolysaccharidosis Type IIIA (MPS IIIA, also known as Sanfilippo syndrome type A).

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 05, 2020

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              Lysogene

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              • Development Update
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              Flag France
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              Lysogene Receives FDA Fast Track Designation for LYS-SAF302 Gene Therapy in MPS IIIA

              Details:

              The AAVance Phase 2/3 clinical study is designed as an open-label, single-arm, multicenter study of LYS-SAF302 for the treatment of MPS IIIA.

              Lead Product(s): Olenasufligene Relduparvovec

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: Phase II/ Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable February 25, 2020

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