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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 improvement vs nadir at 3 years 62% of bilaterally treated patients off-chart at baseline move b...
Pooled analysis of safety data from 5 clinical studies in 189 patients constituting the largest ever ND4- LHON cohort treated with gene therapy Confirmation of the long-term safety profile of intravitreal injections of LUMEVOQ ® with data covering a 5-year period following admini...
GS030 is safe and well tolerated for at least 1 year after injection at all tested doses Encouraging efficacy signals observed in some patients Ongoing recruitment of GS030 extension cohort at the highest dose of 5e11 vg per eye Regulatory News: GenSight Biologics (Euronext:...
GenSight Biologics S.A. press release ( OTC:GSGTF ): 1H GAAP EPS of -€0.23. Revenue of €3.1M (-44.6% Y/Y). For further details see: GenSight Biologics S.A. GAAP EPS of -€0.23, revenue of €3.1M
GenSight Biologics S.A. press release (OTCPK:GSGTF): FY GAAP EPS of -€0.63. Cash and cash equivalents totaled €44.3 million as of December 31, 2021, compared to €37.9 million as of December 31, 2020. “With a current cash runway to early Q1 2023, we are assessing se...
GenSight Biologics (OTCPK:GSGTF) has reached an agreement with the Committee for Advanced Therapies (CAT) of the EMA to extend by 3 months the Day 120 clock stop during the review of the LUMEVOQ Marketing Authorization Application (MAA). The procedure will resume in April 2022 when the C...
The journal of the American Academy of Ophthalmology has published results from GenSight Biologics's ([[GSGTF]] +8.4%) RESCUE pivotal Phase III clinical trial of LUMEVOQ gene therapy in ND4 Leber Hereditary Optic Neuropathy subjects."The study confirms the clinical benfit of rescuing ret...
The European Medicines Agency ((EMA)) accepts for review GenSight Biologics' (GSGTF) marketing application seeking approval of its Lumevoq (lenadongene nolparvovec) gene therapy for the treatment of vision loss in patients with Leber hereditary optic neuropathy, a rare inherited disorder char...
GenSight Biologics S.A. ( OTC:GSGTF ): 1H GAAP EPS of -€0.63. More news on: GenSight Biologics S.A., Earnings news and commentary, , Read more ...
GenSight Biologics S.A. ( OTC:GSGTF ) has achieved the target enrollment of 90 subjects in its Phase 3 clinical trial, REFLECT , evaluating lead gene therapy candidate GS010 in patients with a rare inherited eye disorder called Leber hereditary optic neuropathy (LHON) characterized by v...
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Procedures for obtaining preparatory documents for the General Meeting 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 d...
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 filing of its 2...
Advanced discussions ongoing to secure financing until resumption of early access program (AAC/AAP) expected in Q3 2024 Full alignment sought with regulatory agencies prior to launch of a global Phase III trial supporting both US and EU regulatory submissions for registration of LUMEVOQ ...