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EMA Says Application For Marketing Authorisation For The Advanced Therapy Medicinal Product Lumevoq Withdrawn

Gensight Biologics SA:
EMA SAYS APPLICATION FOR MARKETING AUTHORISATION FOR THE
ADVANCED THERAPY MEDICINAL PRODUCT LUMEVOQ WAS WITHDRAWN
EMA: CHMP RECOMMENDED GRANTING. | April 26, 2023 ....

Gensight Biologics Sa Stock Exchange , Press Release , Ecommended Sight Fr0013183985 ,

GenSight Biologics Withdraws its EMA Application for LUMEVOQ

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 ....

United States , United Kingdom , France General , Gensight Biologics Euronext , Guillaume Van Renterghem , Bernard Gilly , Gensight Biologics , Clothilde Caillet , Patrick Yu , Jeanene Timberlake , Corporate Communications , Phd Cambridge University , European Medicines Agency , Committee For Advanced Therapies , Md University Of Pittsburgh School Medicine , Committee Medicinal Products For Human Use , Regulatory News , Sight Biologics , Advanced Therapies , Committee Medicinal Products , Human Use , Patrick Yu Wai Man , Cambridge University , Alain Sahel , Pittsburgh School , Institut De La Vision ,

GenSight Biologics to Host a Webcast on April 5, 2023, to Provide an Update on LUMEVOQ Manufacturing Following Investigations Findings

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 ....

France General , Guillaume Van Renterghem , Jeanene Timberlake , Gensight Biologics , Clothilde Caillet , James Palmer , Gensight Biologics Euronext , Corporate Communications , Regulatory News , Sight Biologics , Gensight Biologics Manufacturing Update Webcast , Sight Biologic , Mitochondrial Targeting Sequence , Leber Hereditary Optic Neuropathy , Gensight Biologic , Communications Director ,

GenSight Biologics S.A.: GenSight Biologics Confirms Sustained Efficacy and Safety of Bilateral LUMEVOQ Injections at 3-Year Follow-Up of REFLECT Phase III Trial

Sustained efficacy three years after injection: statistically significant visual acuity improvement from nadir Continuous benefits in bilaterally treated patients with +17 to +20 ETDRS letters ....

United States , France General , United Kingdom , Dennis Riedl , James Palmer , Gensight Biologics Euronext , Guillaume Van Renterghem , Nancyj Newman , Jeanene Timberlake , Gensight Biologics , Bernard Gilly , Thomas Gidoin , International Principal Investigator , European Union , European Medicines Agency , Emory University School Of Medicine Atlanta , Best Corrected Visual Acuity , Business Wire , Sight Biologics , Emory University School , Special Protocol Assessment , Leber Hereditary Optic Neuropathy , Sight Biologic , Mitochondrial Targeting Sequence , Gensight Biologic , Hereditary Optic Neuropathy ,

GenSight Biologics S.A.: GenSight Biologics Provides Update on LUMEVOQ Manufacturing and Commercialization Timelines

PPQ campaign to start early May 2023 (previously end of March) with results expected in Q3 2023 EMA CHMP opinion now expected in Q1 2024 (previously September 2023) Regulatory News: GenSight ....

United States , France General , Dennis Riedl , Clothilde Caillet , James Palmer , Gensight Biologics Euronext , Guillaume Van Renterghem , Jeanene Timberlake , Gensight Biologics , Brammer Bio , Bernard Gilly , Corporate Communications , European Medicines Agency , Drug Administration , Manufacturing Sciences , Sight Biologics , Leber Hereditary Optic Neuropathy , Thermo Fisher Scientific , Good Manufacturing Practices , Process Performance Qualification , Manufacturing Operations , Chief Executive Officer , Early Access Authorisation , European Committee , Medicinal Products , Human Use ,