- Combined General Meeting on May 19, 2026
- Key operational developments in 2025 and 2026
PARIS--(BUSINESS WIRE)--Regulatory News:
GenSight Biologics (the “Company”) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharmaceutical company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that its Combined General Meeting will be held tomorrow, Tuesday, May 19, 2026, at 2:00 p.m. CEST and will be broadcast live via the following link: GENSIGHT BIOLOGICS - Assemblée générale 2026.
On this occasion, Laurence Rodriguez, Chief Executive Officer, will present an overview of the achievements in fiscal year 2025 as well as the key priorities for the current fiscal year.
2025 Key Highlights
Fiscal year 2025 was marked by a series of financing rounds that supported operations around the granting of a Named Patient Early Access Program (AAC) in France, as well as early access authorizations in the United States in November and in Israel in December 2025. These financing rounds, together with the arrival of new investors and the support of long-standing shareholders, also enabled the continuation of the manufacturing and testing technology transfer to its industrial partners, a key milestone in securing the LUMEVOQ®/GS0101 supply chain.
2026 Priorities
For fiscal year 2026, GenSight’s management has identified several strategic priorities, which will be detailed during the General Meeting:
- Optimization of the production yield of LUMEVOQ®/GS010, in order to strengthen industrial capacity and reduce the manufacturing cost per batch;
- Finalization of the technology transfer, with a view to completing method qualification;
- Funding and launch of the RECOVER study, the Phase III clinical trial designed to demonstrate the efficacy of LUMEVOQ® in a large number of patients suffering from ND4-LHON. The Company highlights the fact that since the end of March 2026, it has covered its operating expenses through its revenues;
- Review of the regulatory submission strategy with the MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom), the Company having decided to reassess the timeline and the contents of its application to the British agency in light of developments in the regulatory and manufacturing processes.
Participation in the General Meeting
The General Meeting will be accessible via live webcast starting at 2:00 p.m. CEST via the following link: GENSIGHT BIOLOGICS - Assemblée générale 2026.
About GenSight Biologics
GenSight Biologics S.A. is a clinical-stage biopharmaceutical 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, designed to preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics’ lead product candidate, GS010, is in Phase III trials for the treatment of Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. GS030, currently in Phase I/II clinical trials, is an optogenetic-based treatment being investigated as a mutation-independent therapy for late-stage retinitis pigmentosa, the leading cause of blindness worldwide. Using its gene therapy-based approach, GenSight Biologics’ product candidates are designed to be administered in a single intravitreal injection per eye to offer patients a sustainable functional visual recovery.
1 GS010/LUMEVOQ has not, to date, received marketing authorization in any country and is therefore not available commercially.
Contacts
GenSight Biologics
Chief Financial Officer
Jan Eryk Umiastowski
jeumiastowski@gensight-biologics.com
