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GenSight Biologics announces a financing for an amount of c. €1.5 million from existing investors • • Business Wire • Stocks

Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (the " Company "), a biopharma Company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced today a financing through a capital increase reserved to specialized investors by the issuance of new shares with warrants attached, for a total gross amount of c. €1.5 million (excluding the future net proceeds...

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GenSight Biologics Provides Update on Regulatory Discussions and Financial Situation • • Business Wire • Stocks

Regulatory News: GenSight Biologics (" GenSight Biologics " or the " Company ") (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 provided an update on its regulatory discussions with the French medicines safety agency ( Agence Nationale de Sécurité du Médicament et des Produits de Santé or the ANSM) and on its...

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GenSight Biologics Announces Submission of LUMEVOQ® Dossier to ANSM to Prepare for Restart of Early Access Program in France • • Business Wire • Stocks

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 announced the submission of the updated regulatory file for LUMEVOQ ® gene therapy to the French medicines safety agency Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) to prepare for the restart of the...

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GenSight Biologics Obtains Funding of €10 Million From Sofinnova Partners, Invus and UPMC Enterprises • • Business Wire • Stocks

Regulatory News: THIS PRESS RELEASE IS NOT BEING MADE IN AND COPIES OF IT MAY NOT BE DISTRIBUTED OR SENT, DIRECTLY OR INDIRECTLY, INTO THE UNITED STATES, CANADA, SOUTH AFRICA, JAPAN OR AUSTRALIA GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (the " Company "), a biopharma Company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced today the resumption of the trading...

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GenSight Biologics Provides Financial and Operational Update • • Business Wire • Stocks

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 provides an update on its financial and operational situation. Financial Update In the past two months, GenSight has instituted cash preservation measures, including a 40% headcount reduction mainly in Commercial teams, leading to a...

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GenSight Biologics: Annual General Meeting on June 21, 2023 • • Business Wire • Stocks

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, announced that it will hold its Annual General Meeting on June 21, 2023, at 9:00 am CEST at the Company’s headquarters, 74 rue du Faubourg Saint-Antoine, 75012 Paris, France. The General Meeting will also be webcast live for shareholders on...

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GenSight Biologics Announces the Filing of its 2022 Universal Registration Document and Reschedules its Annual General Meeting on June 21, 2023 • • Business Wire • Stocks

Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced the filing of its 2022 Universal Registration Document (URD) in English with the French market authority ( Autorités des Marchés Financiers , or AMF) under the reference D.23-0406. “We are actively preparing...

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GenSight Biologics Announces the Re-approval of its Full Year 2022 Consolidated Financial Statements • • Business Wire • Stocks

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...

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GenSight Biologics Reports Cash Position as of March 31, 2023, and Provides Business Update • • Business Wire • Stocks

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 reported its cash position as of March 31, 2023, and provided a business update. Regulatory Pathway of LUMEVOQ ® In March 2023, as planned, GenSight submitted responses to the D180 questions from the European Medicines Agency (EMA)....

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GenSight Biologics Withdraws its EMA Application for LUMEVOQ® • • Business Wire • Stocks

Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announces that the Committee for Advanced Therapies (CAT) 1 of the Committee Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) assessed the data presented during the oral explanation 2 on...

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GenSight Biologics to Host a Webcast on April 5, 2023, to Provide an Update on LUMEVOQ® Manufacturing Following Investigations Findings • • Business Wire • Stocks

Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announces that its management team will host a live webcast on Wednesday, April 5, 2023, to provide update on LUMEVOQ ® manufacturing issues encountered in March , following investigations findings at the Company’s...

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GenSight Biologics Reports Full Year 2022 Consolidated Financial Results • • Business Wire • Stocks

Regulatory News: GenSight Biologics (Paris:SIGHT) (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 reported its full year 2022 consolidated financial results, as approved by the Board of Directors on March 23, 2023. Audit procedures on the Company’s 2022 consolidated financial statements were completed by the...

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GenSight Biologics Announces Presentation of LUMEVOQ® Efficacy and Safety Data from Early Access Programs for ND4-LHON Patients at NANOS 2023 • • Business Wire • Stocks

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230314006021/en/ Figure 1: Global evolution of mean BCVA over two years in patients who received LUMEVOQ® in early access programs. (Graphic: Business Wire) 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...

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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 • • Business Wire • Stocks

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230312005028/en/ Graph 1: Evolution of Best-Corrected Visual Acuity (BCVA) over time (Graphic: Business Wire) 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 reported topline...

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GenSight Biologics to Present at Upcoming Medical Conferences • • Business Wire • Stocks

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 announced that the Company will participate and present LUMEVOQ ® data at the following upcoming medical conferences taking place in the first half of 2023: North American Neuro Ophthalmology Society (NANOS) 49 th Annual Meeting March...

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GenSight Biologics Announces Publication of LUMEVOQ® Safety Data over 5-Year Period in renowned Peer-Reviewed American Journal of Ophthalmology • • Business Wire • Stocks

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 announced the publication of a peer-reviewed article in the renowned American Journal of Ophthalmology focusing on pooled safety data from the 5 clinical studies with lenadogene nolparvovec (LUMEVOQ ® ). This analysis constitutes the...

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GenSight Biologics Provides Update on LUMEVOQ® Manufacturing and Commercialization Timelines • • Business Wire • Stocks

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 provides an update on the manufacturing and commercialization timelines of LUMEVOQ ® , the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON). Two engineering batches were successfully manufactured 1 as a result of...

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GenSight Biologics Announces its 2023 Financial Calendar • • Business Wire • Stocks

Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced its financial calendar for 2023. Information Date* 2022 Full-Year Financial Update and Statements March 24, 2023 2023 1Q Cash Position April 20, 2023 Annual General Meeting May 16, 2023 2023 First-Half Financial...

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Rare Disease Day 2023: GenSight Biologics Raises Awareness of Leber Hereditary Optic Neuropathy (LHON) • • Business Wire • Stocks

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, highlights its commitment to fight rare neurodegenerative diseases by raising awareness of Leber Hereditary Optic Neuropathy (LHON) at Rare Disease Day through the launch of a European awareness campaign in Q1 2023, in close collaboration...

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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 Pigmentosa • • Business Wire • Stocks

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 announced favorable safety data and encouraging efficacy signals at 1 year post-gene therapy administration for the PIONEER Phase I/II clinical trial evaluating GS030 for the treatment of retinitis pigmentosa (RP) in 9 patients, with a...

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