GS010/LUMEVOQ®
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GenSight Biologics Announces Regulatory Authorization for Early Access Treatment with GS010/LUMEVOQ® in Israel
Businesswire· 2025-12-22 17:00
Core Viewpoint - GenSight Biologics has received authorization from Israel's Ministry of Health for the early access treatment of its gene therapy candidate GS010/LUMEVOQ® for individual patients [1] Company Summary - GenSight Biologics is a biopharma company focused on developing and commercializing innovative gene therapies specifically for retinal neurodegenerative diseases and central nervous system disorders [1]
GenSight Biologics Announces the Granting of Compassionate Use Authorization (CUA/AAC) for GS010/LUMEVOQ® in France
Businesswire· 2025-12-22 06:00
Core Viewpoint - GenSight Biologics has received compassionate use authorization from the French medicines safety agency ANSM for its innovative gene therapies targeting retinal neurodegenerative diseases and central nervous system disorders [1] Company Summary - GenSight Biologics is a biopharma company focused on developing and commercializing gene therapies [1] - The company is listed on Euronext under the ticker SIGHT and is eligible for PEA-PME [1] Regulatory Update - The French medicines safety agency ANSM has granted compassionate use authorization (Autorisation d'Accès Compassionnel, or AA) for GenSight's therapies [1]
GenSight Biologics Announces Regulatory Approval for GS010/LUMEVOQ® REVISE Dose-Ranging Study in France
Businesswire· 2025-12-02 16:43
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 announced that the French medicines safety agency ANSM (Agence nationale de sécurité du médicament et des produits de santé) has authorized the dose-ranging study REVISE, which will investigate the efficacy and. ...
GenSight Biologics Announces Regulatory Authorizations for Individual Patient Expanded Access Treatment with GS010/LUMEVOQ® in the US
Businesswire· 2025-10-30 06:30
Core Insights - GenSight Biologics has received regulatory authorizations for its gene therapy GS010/LUMEVOQ® for Individual Patient Expanded Access in the United States [1] Company Summary - GenSight Biologics is a biopharma company focused on developing and commercializing innovative gene therapies specifically for retinal neurodegenerative diseases and central nervous system disorders [1]