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Regulatory

03 November 2020

GenSight Biologics reports validation of LUMEVOQ® Marketing Authorisation Application (MAA) by European Medicines Agency

15 September 2020

GenSight Biologics Submits EU Marketing Authorisation Application for LUMEVOQ® Gene Therapy to Treat Vision Loss due to Leber Hereditary Optic Neuropathy (LHON)

15 April 2020

GenSight Biologics on Track to Submit LUMEVOQ® for European Approval in September 2020 Following Pre-Submission Meeting with EMA

06 April 2020

GenSight Biologics Provides Update on Operations in the Context of COVID-19

09 December 2019

The Quinze-Vingts Hospital and GenSight Biologics announce a first Temporary Authorization for Use (ATU) for LUMEVOQ™ (GS010) in France

10 January 2018

GenSight Biologics receives MHRA approval to initiate Phase I/II PIONEER clinical trial of GS030 gene therapy in Retinitis Pigmentosa

31 January 2017

GenSight Biologics receives FDA Orphan Drug Designation for GS030 in Retinitis Pigmentosa

08 September 2016

GenSight Biologics receives approval to include teenage patients in RESCUE and REVERSE Phase III trials with GS010 in Leber’s Hereditary Optic Neuropathy

01 September 2016

GenSight Biologics receives Orphan Drug Designation and Advanced Therapy Medicinal Product classification in Europe for GS030 in Retinitis Pigmentosa

10 September 2015

GenSight Biologics Receives IND Acceptance from FDA to Enter Phase III with GS010

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