お知らせ • Apr 14
GenSight Biologics S.A., Annual General Meeting, May 19, 2026 GenSight Biologics S.A., Annual General Meeting, May 19, 2026. Location: 74 rue du faubourg saint antoine, paris France お知らせ • Mar 27
Gensight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2025 GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2025. For the year, the company expected revenues of EUR 1,000; total operating income of EUR 652,000; Operating loss of EUR 11,054,000; Net loss of EUR 12,036,000; Basic and diluted loss per share of EUR 0.08; and Total comprehensive loss of EUR 11,631,000. お知らせ • Mar 10
GenSight Biologics S.A. Provides Updates About GS010/LUMEVOQ Early Access Programs And The Ongoing REVISE Study GenSight Biologics S.A. provided updates on the GS010/LUMEVOQ early access programs currently underway and the ongoing dose-ranging study REVISE. GS010/LUMEVOQ is the Company’s candidate gene therapy in clinical development as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene. Following the authorization of the AAC program by the national medicines safety agency ANSM in December 2025, individual applications that were submitted in February were approved. The Company is completing the administrative steps to finalize delivery of the product to the 15-20 National Hospital, where the treatments have been scheduled for mid- and late March. The dose-ranging study REVISE is progressing on schedule, with the first patient treated in February and the second patient expected to be enrolled over the next few weeks. A second patient in Israel was approved for treatment under the Paid Named Patient Program by the Israeli Ministry of Health. The Company is supporting the logistical activities to ship and administer the treatment by next quarter. A second US patient will be treated as part of the GS010/LUMEVOQ expanded access program after the FDA cleared the single patient IND for the patient in January 2026. The agency’s decision follows the treatment last year of the patient whose individual patient IND was cleared in October 2025. First payments for the treatments in France are expected to be received before the end of March. Although the Company is unable to predict the precise timing of the treatments and payments in the various early access programs in the coming year, the expected revenues in the aggregate, are expected to be sufficient to, at a minimum, ensure the Company’s operational continuity beyond the February 2026 cash horizon indicated in the January 8th press release and, in the ordinary course of business, through 2026. Beyond this baseline, the Company will continue its funding operations, on a dilutive and non-dilutive basis, to further extend the cash runway and in particular to finance the RECOVER Phase III trial. お知らせ • Feb 18
Gensight Biologics Announces Executive Changes GenSight Biologics announced the strategic expansion of its Regulatory Affairs & Quality department with two senior appointments following recent regulatory milestones. The company named Fang Li, Ph.D., RAC, as Chief Regulatory Affairs & Quality Officer, and Sabrina Chekroun, Pharm.D., as Senior Vice President, Regulatory Affairs and Quality. Sabrina Chekroun will report to Fang Li. Fang Li is based in the U.S., and Sabrina Chekroun is based in France
Fang Li brings more than 30 years of experience in drug development, including over 25 years in Regulatory Affairs, with extensive expertise in global product development and approvals across the United States and other regions. She held senior regulatory leadership roles across various pharmaceutical and biotechnology companies, including Opthea Ltd, Oculis SA, Graybug Vision, and Iveric Bio, as well as regulatory positions at organizations such as Novartis, Alcon, Bausch + Lomb, and Warner Chilcott. Her experience in regulatory strategy spans the areas of small molecules, biologics, gene therapies, and medical devices. Dr. Li holds a Ph.D. in Medicinal Chemistry from China Pharmaceutical University, a Master’s degree in Organic Chemistry from Wuhan University, and a Bachelor’s degree in Organic Chemistry from Xiamen University. She is RAC (US) certified. Sabrina Chekroun brings more than 23 years of experience in international Regulatory Affairs, with positions in leading pharmaceutical companies such as Sanofi-Genzyme and AstraZeneca, as well as biotechnology companies such as Abivax and Advicenne, where she held senior leadership positions in Global Regulatory Affairs. She has extensive experience in defining and leading global regulatory strategies across Europe, the United States, and other regions, from early development through post-marketing authorization, with a strong focus on orphan drugs and rare diseases. Ms. Chekroun holds a Doctor of Pharmacy degree from the University of Algiers, a Master’s degree in Industrial Pharmaceutics from the University of Tours, and a Master’s degree in Health Law and Management from the University of Paris XI. お知らせ • Feb 10
The 15-20 National Hospital and Gensight Biologics Announce the Treatment of the First Patient in the GS010/LUMEVOQ Revise Study The 15-20 National Hospital (l'Hopital national des 15-20) in Paris and GenSight Biologics announced the treatment of the first patient enrolled in the REVISE dose-ranging study. The open-label, single center study aims to enroll 14 patients in France. With REVISE now underway, the hospital is currently the only institution in Europe with a clinical study involving GS010/LUMEVOQ, GenSight Biologics' candidate gene therapy being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene1. The named patient requests, each of which resulted from a multidisciplinary consultation, will be individually evaluated by the agency. Enrollment into REVISE is prioritized for patients eligible for both programs. LHON is a rare, maternally inherited mitochondrial genetic disease, characterized by the degeneration of retinal ganglion cells, which results in precipitous and usually irreversible vision loss and typically leads to legal blindness. The ND4 mitochondrial mutation is the most common of the mutations that cause LHON and is associated with the worst prognosis among the leading mutations. A hospital with national standing and university teaching, the 15-20 National Hospital brings together the best medical and care teams and provides dedicated care for visual diseases. In 2018, the hospital founded, with the Institut de la vision, the University Hospital Institute (IHU) FOReSIGHT, whose mission is to promote fundamental research to develop tomorrow's ophthalmology care and provide access to therapeutic innovations through international partnerships and the development of companies involved in preventing and treating eye diseases. お知らせ • Jan 08
GenSight Biologics S.A. announced that it has received funding GenSight Biologics S.A. announced a private placement of Pre-Funded Warrants giving the right to subscribe to 6,571,428 additional ordinary shares of the company, on January 7, 2026. 
