PARIS--(BUSINESS WIRE)--Regulatory News:
GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announces that on April 28, 2023, the Board of Directors re-approved its full year 2022 consolidated financial statements, as updated to reflect the Company's recent decision to withdraw its European Medicines Agency (EMA) application for LUMEVOQ®. Audit procedures on the Company’s full year 2022 consolidated financial statements were additionally completed by the Company’s statutory auditors.
Final certification will take place after the completion of procedures required before the Universal Registration Document is filed with the French market authority (Autorité des Marchés Financiers), currently expected by no later than May 10, 2023.
The full year 2022 financial information as reported by the Company in its press release dated March 24, 2023, have not changed as a result of the full year 2022 consolidated financial statements being re-approved on April 28, 2023. These consolidated financial statements now include information in the notes to the financial statements to reflect the recent withdrawal of the Company's application with the EMA and its change in cash position as disclosed in its press releases dated April 20, 2023, and April 21, 2023, respectively.
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics’ pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, LUMEVOQ® (GS010; lenadogene nolparvovec), is an investigational compound and has not been registered in any country at this stage; a marketing authorization application is currently under review by the EMA for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease affecting primarily teens and young adults that leads to irreversible blindness. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.