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    [{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Grants Orphan Drug Designation to Neurogene\u2019s Gene Therapy for the Treatment of CLN5 Batten Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neurogene Appoints Kenneth Huttner, M.D., Ph.D., as Senior Vice President of Clinical Development","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neurogene Announces FDA Orphan Drug Designation for CLN7 Batten Disease Gene Therapy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neurogene\u2019s CLN7 Gene Therapy Granted FDA Orphan Drug Designation","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"},{"orgOrder":0,"company":"Neurogene","sponsor":"EcoR1 Capital","pharmaFlowCategory":"D","amount":"$115.0 million","upfrontCash":"Undisclosed","newsHeadline":"Neurogene Closes $115 Million Series B Financing","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"Undisclosed","date":"December 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neurogene Announces FDA Clearance of IND for NGN-401 Gene Therapy for Children with Rett Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"Neurogene","sponsor":"Neoleukin Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Neurogene and Neoleukin Announce Definitive Merger Agreement","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Neurogene","sponsor":"Great Point Partners","pharmaFlowCategory":"D","amount":"$95.0 million","upfrontCash":"Undisclosed","newsHeadline":"Neurogene and Neoleukin Announce Definitive Merger Agreement","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neurogene Announces Expansion and Plans for More Rapid Patient Enrollment of Rett Syndrome Gene Therapy Clinical Trial","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Neurogene","sponsor":"Neoleukin Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Neurogene Announces Closing of Merger with Neoleukin Therapeutics and Concurrent Private Placement of $95 Million","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Neurogene","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Neurogene Doses First Patients in Phase 1\/2 Trial of NGN-401 for the Treatment of Female Pediatric Patients with Rett Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"}]

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              Neurogene

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              Neurogene Announces Expansion and Plans for More Rapid Patient Enrollment of Rett Syndrome Gene Therapy Clinical Trial

              Details:

              NGN-401 is an investigational AAV9 gene therapy that delivers the full-length human MECP2 gene. It is being evaluated for the treatment of Rett syndrome.

              Lead Product(s): NGN-401

              Therapeutic Area: Genetic Disease Product Name: NGN-401

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

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 04, 2024

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              Neurogene

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              Neurogene Announces Closing of Merger with Neoleukin Therapeutics and Concurrent Private Placement of $95 Million

              Details:

              The combined company will focus on advancing Neurogene’s pipeline of differentiated genetic medicines, including NGN-401, a clinical-stage product for Rett syndrome, which uses novel gene regulation technology for a potential best-in-class profile.

              Lead Product(s): NGN-401

              Therapeutic Area: Genetic Disease Product Name: NGN-401

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

              Recipient: Neoleukin Therapeutics

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Merger December 19, 2023

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              Neurogene

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              Neurogene Doses First Patients in Phase 1/2 Trial of NGN-401 for the Treatment of Female Pediatric Patients with Rett Syndrome

              Details:

              NGN-401 is a Cell and Gene therapy drug, administered via intracerebroventricular injection, regulating the MECP2 gene for female pediatric patients with Rett Syndrome.

              Lead Product(s): NGN-401

              Therapeutic Area: Genetic Disease Product Name: NGN-401

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

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 30, 2023

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              Neurogene

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              Neurogene and Neoleukin Announce Definitive Merger Agreement

              Details:

              The combined company will focus on advancing Neurogene’s pipeline of differentiated genetic medicines, including NGN-401, a clinical-stage product for Rett syndrome, which uses novel gene regulation technology for a potential best-in-class profile.

              Lead Product(s): NGN-401

              Therapeutic Area: Genetic Disease Product Name: NGN-401

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

              Recipient: Neoleukin Therapeutics

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Merger July 18, 2023

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              Neurogene

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              Neurogene and Neoleukin Announce Definitive Merger Agreement

              Details:

              The net proceeds will be used to advance the devlopment of Neurogene's pipeline, including NGN-401, a clinical-stage product for Rett syndrome, which uses novel gene regulation technology for a potential best-in-class profile.

              Lead Product(s): NGN-401

              Therapeutic Area: Genetic Disease Product Name: NGN-401

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

              Partner/Sponsor/Collaborator: Great Point Partners

              Deal Size: $95.0 million Upfront Cash: Undisclosed

              Deal Type: Private Placement July 18, 2023

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              Neurogene

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              Neurogene Announces FDA Clearance of IND for NGN-401 Gene Therapy for Children with Rett Syndrome

              Details:

              NGN-401 is an adeno-associated virus (AAV) gene therapy investigational product that is the first to deliver the full-length human MECP2 gene, under the control of Neurogene’s EXACT self-contained gene regulation technology.

              Lead Product(s): NGN-401

              Therapeutic Area: Genetic Disease Product Name: NGN-401

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 23, 2023

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              Neurogene Closes $115 Million Series B Financing

              Details:

              Proceeds will accelerate clinical development of multiple gene therapy programs, novel gene therapy product designs, next generation technology platform and state-of-the-art AAV Vector GMP manufacturing capabilities.

              Lead Product(s): AAV-based gene therapy

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: EcoR1 Capital

              Deal Size: $115.0 million Upfront Cash: Undisclosed

              Deal Type: Series B Financing December 16, 2020

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              Neurogene

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              Neurogene Announces FDA Orphan Drug Designation for CLN7 Batten Disease Gene Therapy

              Details:

              The U.S FDA has granted Neurogene the Orphan Drug Designation for its adeno-associated virus vector with engineered transgene encoding the human CLN7 gene for patients with CLN7, a form of Batten disease.

              Lead Product(s): AAV-based engineered transgene

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 11, 2020

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              Neurogene

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              Neurogene’s CLN7 Gene Therapy Granted FDA Orphan Drug Designation

              Details:

              U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to adeno-associated virus vector with engineered transgene encoding the human CLN7 gene for patients with CLN7, a form of Batten disease.

              Lead Product(s): Gene Therapy

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 11, 2020

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              Neurogene

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              Neurogene Appoints Kenneth Huttner, M.D., Ph.D., as Senior Vice President of Clinical Development

              Details:

              Dr. Huttner to lead clinical development as Neurogene advances towards first Investigational New Drug (IND) filing.

              Lead Product(s): AAV-based gene therapy

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: IND Enabling Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 15, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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