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Find Clinical Drug Pipeline Developments & Deals by GenSight Biologics

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            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

            Details:

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

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            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

            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®.

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            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

            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.

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            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: Kreos Capital

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement July 09, 2020

            Details:

            Together with anticipated revenues from the Temporary Authorization for Use of LUMEVOQ® in France, The company expect to be financed until at least mid-2021.

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            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 06, 2020

            Details:

            The new data will reinforce GenSight Biologics’ submission of LUMEVOQ® for marketing authorization in the European Union, which it intends to file in September 2020.

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            Lead Product(s): GS030

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            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 April 14, 2020

            Details:

            The DSMB confirmed the absence of any safety issues for the second cohort of three subjects in PIONEER Phase I/II clinical trial of GS030.

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            Lead Product(s): Lenadogene nolparvovec

            Therapeutic Area: Ophthalmology Product Name: Undisclosed

            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 03, 2020

            Details:

            Bilateral visual recovery observed with GS010 in the REVERSE and RESCUE Phase III trials will be presented and discussed at the 46th Annual Meeting of the North American Neuro-Ophthalmology Society.