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    [{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Announces Presentation of Bilateral Visual Recovery From GS010 Phase III Trials","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Announces Positive Data Safety Monitoring Board Review of PIONEER Phase I\/II Trial of GS030","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Kreos Capital","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"GenSight Biologics Obtains a \u20ac7m Non-Dilutive Loan and Renegotiates the Bond Agreement With Kreos Capital Extending Runway to Mid-2021","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Reports Sustained Efficacy and Safety Among LHON Patients Three Years After LUMEVOQ\u00ae Treatment","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Reports Final REALITY Natural History Study Results Confirming Poor Spontaneous Recovery for LHON Patients With ND4 Mutation","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Submits EU Marketing Authorisation Application for LUMEVOQ\u00ae Gene Therapy for Leber Hereditary Optic Neuropathy","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Diamond Supports GenSight Biologics in LUMEVOQ MAA Submission","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Reports Topline Results from REFLECT Phase III Clinical Trial, Confirming LUMEVOQ\u00ae Efficacy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ\u00ae Injections at 2-Year Follow-Up of REFLECT Phase III Trial","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Reports Clinically Meaningful Vision Improvement is Maintained 4 Years After One-time Treatment with LUMEVOQ\u00ae Gene Therapy","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Reports 5 Years\u2019 Data Showing Sustained Efficacy and Safety Following One-time Treatment With LUMEVOQ","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Announces 1 Year Safety Data and Efficacy Signals from Pioneer Phase I\/II Clinical Trial of GS030, an Optogenetic Treatment Candidate for Retinitis Pigmentosa","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I\/ Phase II","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ\u00ae Injections at 3-Year Follow-Up of REFLECT Phase III Trial","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"GenSight Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ\u00ae Injections Four Years After One-Time Administration","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"}]

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              GenSight Biologics

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              GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ® Injections Four Years After One-Time Administration

              Details:

              Lumevoq (lenadogene nolparvovec) is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2), investigational gene therapy containing the wild-type ND4 gene (rAAV2/2-ND4). It is being evaluated for the treatment of leber hereditary optic neuropathy.

              Lead Product(s): Lenadogene Nolparvovec

              Therapeutic Area: Genetic Disease Product Name: Lumevoq

              Highest Development Status: 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 March 20, 2024

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              GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ® Injections at 3-Year Follow-Up of REFLECT Phase III Trial

              Details:

              Lumevoq® (lenadogene nolparvovec) targets LHON by leveraging a mitochondrial targeting sequence proprietary technology platform, allows it to specifically address defects inside the mitochondria using an AAV vector.

              Lead Product(s): Lenadogene Nolparvovec

              Therapeutic Area: Genetic Disease Product Name: Lumevoq

              Highest Development Status: 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 March 13, 2023

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              GenSight Biologics Announces 1 Year Safety Data and Efficacy Signals from Pioneer Phase I/II Clinical Trial of GS030, an Optogenetic Treatment Candidate for Retinitis Pigme...

              Details:

              GS030 delivered via a single intravitreal injection, introduces a gene encoding for a light-sensitive protein (ChrimsonR-tdT) into retinal ganglion cells, making them responsive to light and bypassing photoreceptors killed off by diseases such as retinitis pigmentosa (RP).

              Lead Product(s): GS030

              Therapeutic Area: Genetic Disease Product Name: GS030

              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 February 13, 2023

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              GenSight Biologics Reports 5 Years’ Data Showing Sustained Efficacy and Safety Following One-time Treatment With LUMEVOQ

              Details:

              Safety findings at 5 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ (GS010/lenadogene nolparvovec) is well-tolerated, no SAE were recorded among LUMEVOQ®-treated eyes, and no discontinuations occurred due to ocular events.

              Lead Product(s): Lenadogene Nolparvovec

              Therapeutic Area: Genetic Disease Product Name: Lumevoq

              Highest Development Status: 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 July 20, 2022

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              GenSight Biologics Reports Clinically Meaningful Vision Improvement is Maintained 4 Years After One-time Treatment with LUMEVOQ® Gene Therapy

              Details:

              Safety findings at 4 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ (lenadogene Nolparvovec) is well-tolerated with no serious adverse events were recorded among LUMEVOQ treated eyes, and no discontinuations occurred due to ocular events.

              Lead Product(s): Lenadogene Nolparvovec

              Therapeutic Area: Genetic Disease Product Name: Lumevoq

              Highest Development Status: 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 January 24, 2022

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              GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ® Injections at 2-Year Follow-Up of REFLECT Phase III Trial

              Details:

              The REFLECT trial’s demonstration of a sustained, significant and safe improvement in visual acuity for LHON patients treated bilaterally with LUMEVOQ provides additional impetus for our push to gain regulatory approval.

              Lead Product(s): Lenadogene Nolparvovec

              Therapeutic Area: Genetic Disease Product Name: Lumevoq

              Highest Development Status: 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 December 14, 2021

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              GenSight Biologics Reports Topline Results from REFLECT Phase III Clinical Trial, Confirming LUMEVOQ® Efficacy

              Details:

              LUMEVOQ® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform.

              Lead Product(s): Lenadogene Nolparvovec

              Therapeutic Area: Genetic Disease Product Name: Lumevoq

              Highest Development Status: 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 30, 2021

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              Diamond Supports GenSight Biologics in LUMEVOQ MAA Submission

              Details:

              Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ.

              Lead Product(s): Lenadogene nolparvovec

              Therapeutic Area: Ophthalmology Product Name: Lumevoq

              Highest Development Status: 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 October 05, 2020

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              GenSight Biologics Submits EU Marketing Authorisation Application for LUMEVOQ® Gene Therapy for Leber Hereditary Optic Neuropathy

              Details:

              GenSight submitted the MAA based on the benefit-risk balance established by results from a Phase-I/IIa study, two pivotal Phase-III efficacy studies and the long-term follow up study of RESCUE and REVERSET to demonstrate the efficacy of LUMEVOQ®.

              Lead Product(s): Lenadogene nolparvovec

              Therapeutic Area: Ophthalmology Product Name: Lumevoq

              Highest Development Status: 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 September 15, 2020

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              GenSight Reports Final REALITY Natural History Study Results Confirming Poor Spontaneous Recovery for LHON Patients With ND4 Mutation

              Details:

              Statistical analysis of the visual acuity in 23 REALITY subjects aged 15 or older with a mutated ND4 gene shows that on average, vision failed to recover from an initial sudden decline, even several years after vision loss.

              Lead Product(s): Lenadogene nolparvovec

              Therapeutic Area: Ophthalmology Product Name: Lumevoq

              Highest Development Status: 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 July 21, 2020

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