Latest news with #LUMEVOQ®
Business Wire
13-05-2025
- Business
- Business Wire
GenSight Biologics Announces Approval of All Resolutions Supported by the Board of Directors at the Combined General Meeting of May 13, 2025
PARIS--(BUSINESS WIRE)--Regulatory News: The Combined General Meeting of shareholders of 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, took place on May 13, 2025, at 2:00 pm CEST at the Company's headquarters, 74 rue du Faubourg Saint-Antoine, 75012 Paris, France. The General Meeting was chaired by Laurence Rodriguez, Chief Executive Officer of the Company. All resolutions recommended by the Board of Directors and submitted to the Combined General Meeting were adopted, with the exception of Resolution A, which was rejected, in accordance with the recommendations of the Board. The quorum on first convening amounted to 56.51%. During the General Meeting, the Chief Executive Officer reviewed the key achievements of 2024, a year marked by careful cash management, strengthened financial structure with the participation of new investors and renewed support from historical shareholders, as well as the renegotiation of the Company's financial obligations. She also highlighted progress in manufacturing, including the optimization of GenSight's technology, preparation for technology transfer to a new manufacturing partner, and the successful mixing and pharmaceutical release of two active substance batches. On the regulatory and clinical fronts, the year saw the preparation of the Phase III RECOVER protocol, the planned submission of the Early Access Program (AAC) application in November 2024, and the continuation of strong scientific communication through international congresses and high-impact journal publications. Looking ahead to 2025, the Company will maintain strict spending discipline while actively pursuing refinancing opportunities. Strategic priorities include the finalization of the Phase III RECOVER protocol in alignment with health authorities, the submission of the LUMEVOQ ® registration dossier to the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and the resumption of the Early Access Program in France through continued engagement with the French agency ANSM. On the manufacturing side, efforts will focus on successfully completing the technology transfer initiated at the end of 2024, optimizing LUMEVOQ ® production yields, and finalizing the quality control plan. In parallel, the Company will continue to explore strategic options through discussions already underway. The results of the vote by resolution and the videocast of the Annual General Meeting will be available on the Company's website in the Investors section ( About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma 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, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery.
Associated Press
17-03-2025
- Business
- Associated Press
GenSight Biologics Announces LUMEVOQ® Scientific Updates at NANOS 2025
Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that new scientific data and analyses on the gene therapy LUMEVOQ ® will be presented at the 51 st Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS) in Tucson, Arizona, USA (March 15-20, 2025). Leading Leber Hereditary Optic Neuropathy (LHON) Key Opinion Leaders will share new data on predictive factors of response to LUMEVOQ ® treatment; on a comparison of the treatment outcomes from idebenone and LUMEVOQ ®; on real-world experience with LUMEVOQ ®; and on long-term outcomes from bilateral treatment with the gene therapy. Poster presentation: ' Predictive Factors of Improved Final Visual Outcome in Patients with Leber Hereditary Optic Neuropathy Treated with Lenadogene Nolparvovec Gene Therapy' Presenter: Robert C. Sergott, MD, Wills Eye Hospital, Philadelphia, USA Poster Number 209 Time: Monday, March 17th, 2025, 5:00 pm – 6:00 pm (MDT) Location: Arizona Ballroom 1-6 Poster presentation: 'Efficacy of Lenadogene Nolparvovec Gene Therapy Versus Idebenone: Two Matched Adjusted Indirect Comparisons' Presenter: Patrick Yu-Wai-Man, MD, PhD, University of Cambridge, Moorfields Eye Hospital, and the UCL Institute of Ophthalmology, UK Poster Number 186 Time: Monday, March 17th, 2025, 6:00 pm – 7:00 pm (MDT) Location: Arizona Ballroom 1-6 Poster presentation: ' Efficacy and Safety of Lenadogene Nolparvovec Gene Therapy for Leber Hereditary Optic Neuropathy in the Real-Life Setting ' Presenter: Mark L. Moster, MD, Wills Eye Hospital, Philadelphia, USA Poster Number 12 Time: Sunday, March 16th, 2025, 2:00 pm – 3:00 pm (MDT) Location: Arizona Ballroom 1-6 Platform presentation: 'Long-Term Outcomes of Bilateral Injection of Lenadogene Nolparvovec Gene Therapy for Leber Hereditary Optic Neuropathy' Presenter: Nancy J. Newman, MD, Emory University School of Medicine, Atlanta, USA Scientific Platform Session I Time: Monday, March 17th, 2025, 11:45 am – 12:00 pm (MDT) Location: Tucson Ballroom About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing 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, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010, is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. About Leber Hereditary Optic Neuropathy (LHON) Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1 st eye, with the 2 nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of subjects have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. About LUMEVOQ ® (GS010; lenadogene nolparvovec) LUMEVOQ ® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. 'LUMEVOQ' was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018. LUMEVOQ ® (GS010; lenadogene nolparvovec) has not been registered in any country at this stage. Chief Financial Officer Jan Eryk Umiastowski [email protected] Advisors Investor Relations Guillaume van Renterghem +41 (0)76 735 01 31 SOURCE: GenSight Biologics Copyright Business Wire 2025. PUB: 03/17/2025 02:30 AM/DISC: 03/17/2025 02:29 AM
Yahoo
17-03-2025
- Business
- Yahoo
GenSight Biologics Announces LUMEVOQ® Scientific Updates at NANOS 2025
PARIS, March 17, 2025--(BUSINESS WIRE)--Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that new scientific data and analyses on the gene therapy LUMEVOQ® will be presented at the 51st Annual Meeting of the North American Neuro-Ophthalmology Society (NANOS) in Tucson, Arizona, USA (March 15-20, 2025). Leading Leber Hereditary Optic Neuropathy (LHON) Key Opinion Leaders will share new data on predictive factors of response to LUMEVOQ® treatment; on a comparison of the treatment outcomes from idebenone and LUMEVOQ®; on real-world experience with LUMEVOQ®; and on long-term outcomes from bilateral treatment with the gene therapy. Poster presentation: "Predictive Factors of Improved Final Visual Outcome in Patients with Leber Hereditary Optic Neuropathy Treated with Lenadogene Nolparvovec Gene Therapy" Presenter: Robert C. Sergott, MD, Wills Eye Hospital, Philadelphia, USA Poster Number 209 Time: Monday, March 17th, 2025, 5:00 pm – 6:00 pm (MDT) Location: Arizona Ballroom 1-6 Poster presentation: "Efficacy of Lenadogene Nolparvovec Gene Therapy Versus Idebenone: Two Matched Adjusted Indirect Comparisons" Presenter: Patrick Yu-Wai-Man, MD, PhD, University of Cambridge, Moorfields Eye Hospital, and the UCL Institute of Ophthalmology, UK Poster Number 186 Time: Monday, March 17th, 2025, 6:00 pm – 7:00 pm (MDT) Location: Arizona Ballroom 1-6 Poster presentation: "Efficacy and Safety of Lenadogene Nolparvovec Gene Therapy for Leber Hereditary Optic Neuropathy in the Real-Life Setting" Presenter: Mark L. Moster, MD, Wills Eye Hospital, Philadelphia, USA Poster Number 12 Time: Sunday, March 16th, 2025, 2:00 pm – 3:00 pm (MDT) Location: Arizona Ballroom 1-6 Platform presentation: "Long-Term Outcomes of Bilateral Injection of Lenadogene Nolparvovec Gene Therapy for Leber Hereditary Optic Neuropathy" Presenter: Nancy J. Newman, MD, Emory University School of Medicine, Atlanta, USA Scientific Platform Session I Time: Monday, March 17th, 2025, 11:45 am – 12:00 pm (MDT) Location: Tucson Ballroom About GenSight Biologics GenSight Biologics S.A. is a clinical-stage biopharma company focused on discovering and developing 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, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010, is in Phase III trials in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. About Leber Hereditary Optic Neuropathy (LHON) Leber Hereditary Optic Neuropathy (LHON) is a rare maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells that results in brutal and irreversible vision loss that can lead to legal blindness, and mainly affects adolescents and young adults. LHON is associated with painless, sudden loss of central vision in the 1st eye, with the 2nd eye sequentially impaired. It is a symmetric disease with poor functional visual recovery. 97% of subjects have bilateral involvement at less than one year of onset of vision loss, and in 25% of cases, vision loss occurs in both eyes simultaneously. About LUMEVOQ® (GS010; lenadogene nolparvovec) LUMEVOQ® (GS010; lenadogene nolparvovec) targets Leber Hereditary Optic Neuropathy (LHON) by leveraging a mitochondrial targeting sequence (MTS) proprietary technology platform, arising from research conducted at the Institut de la Vision in Paris, which, when associated with the gene of interest, allows the platform to specifically address defects inside the mitochondria using an AAV vector (Adeno-Associated Virus). The gene of interest is transferred into the cell to be expressed and produces the functional protein, which will then be shuttled to the mitochondria through specific nucleotidic sequences in order to restore the missing or deficient mitochondrial function. "LUMEVOQ" was accepted as the invented name for GS010 (lenadogene nolparvovec) by the European Medicines Agency (EMA) in October 2018. LUMEVOQ® (GS010; lenadogene nolparvovec) has not been registered in any country at this stage. View source version on Contacts GenSight Biologics Chief Financial OfficerJan Eryk Umiastowskijeumiastowski@ LifeSci Advisors Investor RelationsGuillaume van Renterghemgvanrenterghem@ +41 (0)76 735 01 31 Sign in to access your portfolio
