View ValuationGenSight Biologics 将来の成長Future 基準チェック /56GenSight Biologicsは、88.6%と76.3%でそれぞれ年率88.6%で利益と収益が成長すると予測される一方、EPSはdeclineで67.7%年率。主要情報88.6%収益成長率-67.67%EPS成長率Biotechs 収益成長24.6%収益成長率76.3%将来の株主資本利益率n/aアナリストカバレッジLow最終更新日16 Jul 2026今後の成長に関する最新情報お知らせ • Mar 27Gensight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2025GenSight 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 01GenSight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2024GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2024. For the year, the company expected revenues of EUR 1,500,000; total operating income of EUR 2,625,000; Operating loss of EUR 15,813,000; Net loss of EUR 14,001,000; Basic and diluted loss per share of EUR 0.15; and Total comprehensive loss of EUR 14,172,000.すべての更新を表示Recent updatesお知らせ • Apr 14GenSight Biologics S.A., Annual General Meeting, May 19, 2026GenSight Biologics S.A., Annual General Meeting, May 19, 2026. Location: 74 rue du faubourg saint antoine, paris Franceお知らせ • Mar 27Gensight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2025GenSight 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 10GenSight Biologics S.A. Provides Updates About GS010/LUMEVOQ Early Access Programs And The Ongoing REVISE StudyGenSight 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 18Gensight Biologics Announces Executive ChangesGenSight 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 10The 15-20 National Hospital and Gensight Biologics Announce the Treatment of the First Patient in the GS010/LUMEVOQ Revise StudyThe 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 08GenSight Biologics S.A. announced that it has received fundingGenSight 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.お知らせ • Dec 23+ 1 more updateGenSight Biologics S.A. to Report First Half, 2026 Results on Sep 29, 2026GenSight Biologics S.A. announced that they will report first half, 2026 results on Sep 29, 2026お知らせ • Dec 03GenSight Biologics Announces Regulatory Approval for GS010/LUMEVOQ REVISE Dose-Ranging Study in FranceGenSight Biologics announced that the French medicines safety agency ANSM (Agence nationale de securite du medicament et des produits de sante) has authorized the dose-ranging study REVISE, which will investigate the efficacy and safety of two dose levels of the Company's candidate gene therapy GS010/LUMEVOQ. Two (2) clinical doses will be investigated in the trial, with patients distributed equally over the two doses. Efficacy, as measured by the change in Best Corrected Visual Acuity (BCVA), 1.5 years post-treatment versus baseline, is the primary endpoint in REVISE. The study is expected to begin in January 2026. While the AAC application is under review, GenSight Biologics is moving forward according to target timelines with the final stages of the technology transfer to its new manufacturing partner and with the preparations to finalize the protocol for the Phase III study. In parallel, the Company is pursuing opportunities to out-license GS010 in markets outside the USA and Europe, while exploring paid Early Access Programs worldwide. 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.お知らせ • Oct 30GenSight Biologics Announces Regulatory Authorizations for Individual Patient Expanded Access Treatment with GS010/LUMEVOQ in the USGenSight Biologics announced that the Company's gene therapy GS010/LUMEVOQ has been granted regulatory authorizations for an Individual Patient Expanded Access in the United States. The authorizations mark the first set of regulatory green lights for the candidate product since the Company's withdrawal of its European marketing authorization application in 2023. FDA authorization was granted for expanded access treatment of one eligible patient, based on an application by a physician at the University of Pittsburgh School of Medicine (UPMC) to the agency. The required approval of the school's Institutional Review Board (IRB) was also granted. The patient is scheduled to be treated in November 2025. GS010/LUMEVoQ is in Phase III of its clinical development as a treatment for the rare blinding disease Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene and has not received marketing authorization in any country. The Company is currently completing the technology transfer to its new manufacturing partner, Catalent, which is expected to be finalized by year-end 2025. The transition will enable the production of new batches in 2026 to address the full scope of projected clinical and early access needs. GenSight Biologics is preparing for the launch in H2 2026 of the pivotal Phase III study RECOVER for GS010/LUMEV OQ, while engaging with the French medicines agency ANSM regarding a dose-ranging study the agency requested in connection with an Early Access Program (AAC) in France.お知らせ • Jul 24GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €0.5 million.GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €0.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,941,176 Price\Range: €0.17 Transaction Features: Reserved Share Offeringお知らせ • Jul 04GenSight Biologics S.A. announced that it has received fundingGenSight Biologics S.A. announced a private placement of 1,850,000 pre-funded warrants giving the right to subscribe to 1,850,000 additional ordinary shares on July 3, 2025.お知らせ • Jun 26GenSight Biologics Announces Significant Milestone in New Manufacturing Partnership with CatalentGenSight Biologics announced the successful transfer of the upstream phase of the manufacturing process for LUMEVOQ®?, the Company's gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to its new manufacturing partner, Catalent Inc.お知らせ • Apr 08GenSight Biologics S.A., Annual General Meeting, May 13, 2025GenSight Biologics S.A., Annual General Meeting, May 13, 2025. Location: 74 rue du faubourg saint antoine, paris Franceお知らせ • Mar 07GenSight Biologics S.A. has filed a Follow-on Equity Offering in the amount of €0.860839 million.GenSight Biologics S.A. has filed a Follow-on Equity Offering in the amount of €0.860839 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 3,829,355 Price\Range: €0.2248 Security Features: Attached Warrants Transaction Features: Subsequent Direct Listingお知らせ • Mar 01GenSight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2024GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2024. For the year, the company expected revenues of EUR 1,500,000; total operating income of EUR 2,625,000; Operating loss of EUR 15,813,000; Net loss of EUR 14,001,000; Basic and diluted loss per share of EUR 0.15; and Total comprehensive loss of EUR 14,172,000.お知らせ • Jan 24+ 1 more updateGenSight Biologics S.A. to Report Fiscal Year 2024 Final Results on Mar 19, 2025GenSight Biologics S.A. announced that they will report fiscal year 2024 final results on Mar 19, 2025お知らせ • Jan 15GenSight Biologics Announces Publication of 5-Year Outcomes for Patients Treated Unilaterally with LUMEVOQ Gene TherapyGenSight Biologics announced the publication of outcomes data from five years’ follow-up of patients treated unilaterally with LUMEVOQ, the company’s investigational gene therapy for Leber Hereditary Optic Neuropathy due to a mutated ND4 mitochondrial gene. The patients had all participated in the Phase III trials RESCUE and REVERSE and accepted enrolling into the long-term study RESTORE at the end of the RESCUE and REVERSE studies. The paper, published online by the leading journal JAMA Ophthalmology in December 2024, found that patients “demonstrated a sustained bilateral improvement in BCVA [Best-Corrected Visual Acuity] and a good safety profile over 5 years after treatment”. The “persistent benefit” continues the durable effect observed at earlier time points and represents a significant addition to the body of evidence on the benefit-risk ratio of LUMEVOQ gene therapy in ND4 LHON patients. When RESTORE participants enrolled in the study, 2 years after the one-time injection, they had already experienced clinically meaningful improvement relative to the lowest point of their Best-Corrected Visual Acuity: +20 ETDRS letters equivalent in their LUMEVOQ®-treated eyes and +17 ETDRS letters equivalent in their sham-treated eyes. Five years after treatment, the bilateral improvement from nadir was sustained, with LUMEVOQ®-treated eyes achieving a mean improvement against nadir of +22 letters equivalent and sham-treated eyes demonstrating a mean improvement of +20 letters equivalent. Responder analyses at Year 5 indicate that improved BCVA was a benefit for a substantial proportion of the study participants. 66.1% of RESTORE participants achieved clinically meaningful (at least +3 lines’ improvement) from nadir in at least one eye, and the proportion rises to 71.0% if the criterion used is Clinically Relevant Recovery against nadir. At the end of the five-year follow-up period, 80.6% of participants had on-chart vision (BCVA = 1.6 LogMAR) in at least one eye. The impact of such results on patients is demonstrated by increases in the self-reported quality of life scores at Year 5 vs. baseline. Clinically significant improvement from baseline was observed in 7 of 10 subscale scores of the NEI VFQ-25 questionnaire used to assess quality of life. The composite score showed a clinically meaningful gain of 7 points from baseline. Safety findings at 5 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ is well-tolerated. The systemic safety was excellent and most ocular events were mild, none were severe or serious, and none led to study discontinuation. RESTORE is one of the larger long-term follow-up studies for a rare disease treatment, with 62 participants accepting the invitation to enroll. All participants were treated with a single intravitreal injection of LUMEVOQ in one eye and with sham injection in the other.お知らせ • Nov 13GenSight Biologics Announces Submission of LUMEVOQ Dossier to ANSM to Prepare for Restart of Early Access Program in FranceGenSight Biologics S.A. announced the submission of the updated regulatory file for LUMEVOQ gene therapy to the French medicines safety agency Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) to prepare for the restart of the early access (AAC) program in France. The submission documents the successful manufacture of LUMEVOQ, including the blending of two GMP drug substance batches to optimize the number of vials available for clinical use and the passing of all required quality control tests. LUMEVOQ is being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene, a rare mitochondrial genetic disease that causes acute and usually irreversible loss of vision. The updated regulatory file will support the ANSM’s assessment of individual applications for compassionate use, which can now be submitted by healthcare professionals under the rules of the AAC program. GenSight Biologics anticipates a review period for these applications and will work closely with the ANSM to optimize the assessment timeline. GenSight Biologics is preparing to initiate the supply of the drug to the designated treatment center, the Quinze-Vingts hospital in Paris, in mid-December. In parallel, the Company is working with the hospital’s administrative and medical teams to enable the first injections to be administered by the end of December.お知らせ • Jul 23GenSight Biologics S.A. Provides Business UpdateGenSight Biologics S.A. announced that the manufacture of LUMEVOQ drug product, which required an additional blending step to optimize the number of vials available for the early access program, was successfully performed in July as scheduled. Vials from the batch are now being tested for conformity to the required quality control standards. After accounting for testing requirements, over 100 vials could be available for patients. The full set of quality control results are expected in early September. If the quality control criteria are met, the Company expects to be ready to resumption the AAC program in late September 2024. In parallel, the Company has been engaging with the French medicines safety agency ANSM (Agence Nationale de Securite du Medicament et des produits de sante) and working with the Quinze-Vingts Hospital in Paris, France, to prepare for the resumption of the AAC program, as long anticipated by patients.お知らせ • Jun 05+ 1 more updateGensight Biologics S.A. Appoints William Monteith to Its Board of DirectorsGenSight Biologics announced the appointment of William Monteith to its Board of Directors. Mr. Monteith joined as an independent Director after existing Board members approved his nomination at the meeting on May 29, 2024. William Monteith has over 43 years of experience in both small molecule and large molecule pharmaceutical manufacturing, during which he held increasing positions of responsibility for Operations, Quality and Technical Support. He has been directly involved in the site search, design and build out of 6 pharmaceutical and biotech facilities. While at Wyeth and Sandoz he oversaw the successful implementation of remediation activities for regulatory actions. He was the General Manager for Dendreon when the company became the first to gain approval for and launch an immunotherapy made from a patient’s own cells. He later became the Executive Vice President of Dendreon responsible for the manufacturing, supply chain and the launch of Provenge® in Europe. After the sale of Dendreon to Valeant, he was appointed Chief Operating Officer at Progenitor Cell Therapy, a CDMO that was eventually acquired by Hitachi Chemical. During his role with Hitachi, he oversaw the expansion of their Allendale, NJ, USA, facility as well as the buildout of a cell and gene therapy facility in Yokohama Japan. Upon leaving Hitachi Chemical Advanced Therapies, Bill joined Cellectis as the Vice President Manufacturing, North America where he was responsible for locating a CarT manufacturing facility in North America, eventually overseeing the purchase and build out of a facility in Raleigh, North Carolina. Shortly after the buildout, Bill was appointed the Executive Vice President of Global Operations for Cellectis responsible for operational departments in both Raleigh and Paris. Upon leaving Cellectis, Bill was named Chief Operating Officer for Stridebio, a research development company focused on AAV products for rare diseases. There he was responsible for the buildout of the operations departments and a clinical manufacturing facility. Since his retirement, Bill has taken the role of Program Director for the North Carolina Life Sciences Biomanufacturing Forum, a trade organization that advocates for the life sciences companies that operate in the state.お知らせ • Apr 05GenSight Biologics S.A. to Report First Half, 2024 Final Results on Sep 23, 2024GenSight Biologics S.A. announced that they will report first half, 2024 final results on Sep 23, 2024お知らせ • Mar 12GenSight Biologics Announces Initial Results from New Meta-Analyses on Visual Outcomes with LUMEVOQ® Gene Therapy at NANOS 2024GenSight Biologics announced initial results of new meta-analyses in Leber Hereditary Optic Neuropathy (LHON), which show those treated with LUMEVOQ® (GS010; lenadogene nolparvovec) gene therapy experienced a rate of visual recovery greater than that of idebenone-treated patients and untreated (natural history) patients. The meta-analyses are the first to focus solely on patients with the m.11778G>A ND4 mutation, which is the most common mutation and one with a poor visual prognosis. The meta-analyses depict a gradient of efficacy of visual recovery with LUMEVOQ® intravitreal gene therapy resulting in greater recovery rates than that of idebenone treatment, and both greater than that in the natural history of the disease. This gradient of recovery, based on the CRR measure of visual improvement, is observed at both eye level and patient level(response in one or both eyes). There is no overlap in confidence intervals when LUMEVOQ® is compared to idebenone and to natural history, indicating a positive difference in visual outcomes.お知らせ • Mar 06GenSight Biologics Announces Update on Real-World Data from Early Access Programs of LUMEVOQ® Gene Therapy at NANOS 2024GenSight Biologics has unveiled promising findings from recent real-world data gathered through early access programs (EAP). These data reinforce the efficacy and safety of LUMEVOQ® in patients with Leber Hereditary Optic Neuropathy (LHON) stemming from the ND4 mutation (ND4-LHON), corroborating outcomes observed in clinical trials. Notably, patients who received bilateral injections exhibited a remarkable average gain of +23 ETDRS letters in best-corrected visual acuity (BCVA) from nadir, surpassing the gains seen in patients with unilateral injections. These results, presented at the 2024 annual meeting of the North American Neuro-Ophthalmology Society (NANOS), indicate significant visual improvement among a majority of treated patients. Dr. Chiara La Morgia, MD, PhD, emphasized the consistency and robustness of these findings, underlining their relevance for patients grappling with severe vision impairment. With a more comprehensive dataset compared to earlier releases, these analyses offer a definitive perspective on the sustained upward trajectory of mean visual acuity post-treatment, further supporting the viability of lenadogene nolparvovec as a therapeutic option. Additionally, safety assessments aligned with previous clinical studies, affirming the favorable safety profile of LUMEVOQ® with comparable rates of intraocular inflammation events. These promising outcomes herald a new chapter in the treatment landscape for LHON patients, promising hope and tangible benefits for those afflicted with this debilitating condition.お知らせ • Feb 08GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €5 million.GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €5 million. Security Name: Shares Security Type: Common Stock Securities Offered: 13,061,651 Price\Range: €0.3828 Transaction Features: Subsequent Direct Listingお知らせ • Jan 26Gensight Biologics S.A. Announces CFO ChangesGenSight Biologics S.A. announced that Thomas Gidoin, Chief Financial Officer since 2015, has resigned, effective January 26, 2024. An interim CFO was appointed until a permanent replacement is recruited.お知らせ • Jan 17GenSight Biologics Announces Board ChangesThe Board of Directors of GenSight Biologics acknowledged the resignation of Mr. Bernard Gilly from his position as director. The Board of Directors of the Company also announced its decision, after consultation of the Nomination Committee, to co-opt Mrs. Laurence Rodriguez as director for the remainder of Bernard Gilly’s term of office (expiring at the end of the annual shareholders meeting to be held in 2024 to approve the financial statements for the financial year ending December 31, 2023). The co-optation of Laurence Rodriguez will be subject to ratification by the next shareholders’ meeting of the Company. Laurence Rodriguez appointment as Chief Executive Officer became effective on December 21, 2023. She has over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of executive roles. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of various rare disease products developed or acquired by the Company. She joined GenSight Biologics in May 2021 as Head of Operations for France. She handled the early access program in preparation for LUMEVOQ®'s commercialization and created strong relationships with the stakeholders.お知らせ • Dec 22GenSight Biologics S.A. Announces CEO ChangesGenSight Biologics announced the appointment of Mrs. Laurence Rodriguez, as new Chief Executive Officer. Laurence Rodriguez has over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of executive roles. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of various rare disease products developed or acquired by the Company. She joined GenSight Biologics in May 2021 as Head of Operations for France. She handled the early access program in preparation for LUMEVOQ's commercialization and created strong and trustworthy relationships with the various stakeholders. Laurence Rodriguez holds a Bachelor’s degree in Nutrition and Biochemistry and a Master’s degree from Sciences Po, Paris, France, and completed an Organization Leadership Program at the Harvard Business School. The board of directors thanked Bernard Gilly, co-founder of the Company in 2012 together with Pr. José-Alain Sahel, for his many years of dedication to the Company and his essential contribution to make LUMEVOQ a life changing therapy. He will remain a director of the Company while he no longer assumes operational responsibilities.お知らせ • Nov 17Gensight Biologics S.A. Confirms Second Successful GMP Batch of LumevoqGenSight Biologics S.A. announced that an independent laboratory confirmed the vg titer from the second drug substance (DS) batch of LUMEVOQ manufactured under conditions compliant with Good Manufacturing Practice (GMP) standards. As a result from the confirmation, the Company became eligible to draw down the second tranche of the bridge financing signed in August 2023 with Sofinnova Partners, Invus and UPMC Enterprises (the "Bridge Financing"). The drawdown of the second tranche will also trigger the automatic conversion of the convertible bonds from the €6 million first tranche at a conversion price of EUR 0.7122. This second tranche, amounting to €4 million, will extend the Company’s cash runway to mid-December 2023. GenSight Biologics needs to seek other sources of debt, other non-dilutive or equity financing in order to supplement its working capital requirements and fund its operating expenses beyond that date and until the resumption of the early access program in France (Autorisation d’Accès Compassionnel or AAC) expected in the beginning of the second quarter of 2024. GenSight Biologics estimates that, in addition to the second tranche of the Bridge Financing, it will need approximately €10 million to finance its activities until that date.お知らせ • Nov 14GenSight Biologics S.A. Announces Preliminary Assay Indicating Successful Manufacture of Second LUMEVOQ® GMP BatchGenSight Biologics S.A. announced that a preliminary assay of the viral genome (vg) titer indicates the successful manufacture of a second batch of drug substance (DS) for LUMEVOQ®, the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. The assay, while preliminary, is known to be predictive of the final result at the independent laboratory used for the official release assay. Because the batch was manufactured according to GMP manufacturing protocols, which are the required standards for commercial batches, the gene therapy from the drug substance of this batch may be eligible for use with patients after passing all quality control tests and pending discussions with regulatory bodies. Preparations are underway for the third GMP batch of the campaign planned by the Company. As with the two batches successfully manufactured so far, all of which are outside the context of a validation campaign1, the third batch will generate more process data for a future Marketing Authorisation Application (MAA) submission, provide more experience of the manufacturing process to the operating teams, and help fulfill the immediate requirement of supplying product for the new RECOVER clinical trial and for the potential resumption of an early access program for patients in the beginning of the second quarter of 2024. GenSight Biologics will communicate further in the next few days when the vg titer results are confirmed by the independent laboratory. Upon this confirmation, the Company would be eligible to drawdown the second tranche of €4 million from the bridge financing signed in August 2023 with Sofinnova Partners, Invus and UPMC Enterprises. The cash runway would be extended to mid-December 2023 with the drawdown of the second tranche of the Bridge Financing for an amount of €4 million. Following the drawdown of the second tranche, GenSight Biologics needs to seek other sources of debt, other non-dilutive or equity financing beyond that date in order to supplement its working capital requirements and fund its operating expenses until the resumption of the early access program in France (Autorisation d’Accès Compassionnel or AAC) expected in the beginning of the second quarter of 2024. GenSight Biologics estimates that, in addition to the second tranche of the Bridge Financing, it will need approximately €10 million to finance its activities until that date.お知らせ • Sep 27GenSight Biologics Provides Update on European Medicines Agency Scientific Advice for LUMEVOQGenSight Biologics provided an update on the scientific advice it received from the European Medicines Agency (EMA) regarding the design of a new Phase III trial for LUMEVOQ, the Company's gene therapy for LHON caused by a mutated ND4 mitochondrial gene. The new study, which will be called RECOVER, will be a randomized controlled trial with a two-arm design: a sham control arm, in which a sham procedure mimics an injection into each eye but no substance is injected into the eye, and a treatment arm, in which subjects will be given bilateral intravitreal injections of LUMEVOQ (also known as GS010) The Agency found that the "proposed study design with bilateral administration appears acceptable to assess the benefits of GS010 in patients who require both eyes to be treated". The proposed study design also contains an open-label provision, in which subjects in the sham arm will be eligible to receive LUMEVOQ bilateral injection if the primary endpoint is met. The Agency provided further guidance on planned statistical analyses and advised on topics that the Company will consider as it refines and finalizes the study design. The RECOVER study is designed to address the questions raised by the EMA's Committee for Advanced Therapies (CAT) when it reviewed the MAA filed in 2020. The Company decided to withdraw the dossier in April 2023 to be able to discuss the Agency's concerns more fully. RECOVER will be able to begin recruiting once the design is finalized; the product is manufactured and released for human use; and approval is obtained from local competent authorities and ethics committees. GenSight expects to initiate the study in second quarter 2024 and to have it completed by second quarter 2026. GenSight also plans to share key aspects of RECOVER's design with other regulatory authorities such as the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA). An initial discussion with the MHRA is scheduled to take place in November 2023. The Company plans to engage with the FDA in the coming months, so that RECOVER results will be accepted by all major regulatory authorities.お知らせ • Sep 18GenSight Biologics Announces Successful Manufacture of LUMEVOQ GMP BatchGenSight Biologics announced that the Company's manufacturing partner in the US has successfully manufactured the drug substance (DS) for LUMEVOQ®?, the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. Because the batch was manufactured according to GMP manufacturing protocols, which are the required standards for commercial batches, the gene therapy may be eligible for use with patients after passing all quality control tests and pending discussions with regulatory bodies. The manufacturing of a second GMP DS batch, which will increase the amount that can be made available to patients, is already underway, with vg titer results expected in October 2023. GenSight is planning to manufacture at least 3 GMP batches at commercial scale outside the context of a validation campaign1, to generate more process data for a future Marketing Authorisation Application (MAA) submission, to provide more experience of the manufacturing process to the operating teams, and to fulfil the immediate requirement of supplying product for a possible new clinical trial and for the potential resumption of an early access program for patients in first quarter of 2024.お知らせ • Feb 13GenSight Biologics Announces 1 Year Safety Data and Efficacy SignalsGenSight Biologics announced favorable safety data and encouraging efficacy signals at 1 year post-gene therapy administration for the PIONEER Phase I/II clinical trial evaluating GS030 for the treatment of retinitis pigmentosa (RP) in 9 patients, with a follow-up up to 4 years (n=1). RP is a genetic blinding disease that affects between 15,000 and 20,000 new patients each year in the US and the EU for which there is currently no treatment. PIONEER is a first-in-human, multi-center, open-label dose escalation clinical trial evaluating the safety and tolerability of GS030, an optogenetic treatment candidate combining an AAV2- based gene therapy (GS030-DP) with the use of light-stimulating goggles (GS030-MD) in patients with end-stage RP. This therapeutic approach is independent of the causal mutation and therefore applicable to potentially all patients suffering from end-stage RP. Three cohorts of three patients each were administered one of three doses of GS030-DP (5e10 vg; 1.5e11 vg; 5e11 vg) via a single intravitreal injection in their worst affected eye (i.e., the least-seeing eye). A Data Safety Monitoring Board (DSMB) reviewed the safety data of all treated subjects in each cohort and made recommendations before the extension cohort was enrolled. Based on the good safety profile of GS030, the DSMB recommended selecting the highest dose (5e11 vg) for the extension cohort where patients are currently being recruited. The safety and tolerability results in the first three completed cohorts recorded only mild and moderate (grade 1 and 2) ocular adverse events (AEs) but no severe (grade 3) AEs, with a follow-up up to 4 years (n=1). The most common ocular AEs were mild intraocular inflammation responsive to corticosteroid treatment. Intraocular inflammation occurred in 70% of patients and resolved without sequalae in all patients. The first use of GS030-MD was performed 8 weeks after injection under medical supervision and the light-stimulating goggles were well tolerated. Subjects performed multiple training sessions in parallel to scheduled study visits. The patients from the highest dose cohort have reached 1-year post-gene therapy administration, enabling the assessment of efficacy signals at one year for the 3 cohorts. Encouraging signs of efficacy at 1 year were demonstrated in some patients after GS030 optogenetic treatment with a vision that improved from being barely able to perceive light before treatment to being able to locate and count objects, with the best results at the highest dose.業績と収益の成長予測OTCPK:GSGT.F - アナリストの将来予測と過去の財務データ ( )EUR Millions日付収益収益フリー・キャッシュフロー営業活動によるキャッシュ平均アナリスト数12/31/20287691010112/31/202742-100112/31/202611-9-7-7212/31/20251-12-9-9N/A9/30/20251-14-9-9N/A6/30/20251-15-8-8N/A3/31/20252-15-10-10N/A12/31/20243-14-13-13N/A9/30/20242-17-14-14N/A6/30/20242-20-16-16N/A3/31/20242-23-20-20N/A12/31/20233-26-25-25N/A9/30/20233-28-29-29N/A6/30/20233-29-33-33N/A3/31/20234-28-34-34N/A12/31/20225-28-34-34N/A9/30/20225-29-29-29N/A6/30/20225-31-24-24N/A3/31/20226-30-20-20N/A12/31/20218-29-17-17N/A9/30/20219-28-18-18N/A6/30/202111-28-19-19N/A3/31/20219-31-17-17N/A12/31/20207-34-15-15N/A9/30/20207-31-15-15N/A6/30/20206-28-15-15N/A3/31/20205-30-22-22N/A12/31/20195-31-28-28N/A9/30/20195-35N/A-31N/A6/30/20195-39N/A-35N/A3/31/20195-36N/A-32N/A12/31/20184-33N/A-28N/A9/30/20184-30N/A-25N/A6/30/20184-26N/A-21N/A3/31/20184-25N/A-20N/A12/31/20174-24N/A-19N/A9/30/20173-23N/A-19N/A6/30/20173-23N/A-20N/A3/31/20173-22N/A-20N/A12/31/20163-22N/A-20N/A9/30/20163-20N/A-18N/A6/30/20164-18N/A-17N/A3/31/20164-16N/A-15N/A12/31/20154-14N/A-12N/A9/30/20153-11N/A-10N/Aもっと見るアナリストによる今後の成長予測収入対貯蓄率: GSGT.Fは今後 3 年間で収益性が向上すると予測されており、これは 貯蓄率 ( 3.5% ) よりも高い成長率であると考えられます。収益対市場: GSGT.F今後 3 年間で収益性が向上すると予想されており、これは市場平均を上回る成長と考えられます。高成長収益: GSGT.F今後 3 年以内に収益を上げることが予想されます。収益対市場: GSGT.Fの収益 ( 76.3% ) US市場 ( 12.5% ) よりも速いペースで成長すると予測されています。高い収益成長: GSGT.Fの収益 ( 76.3% ) 20%よりも速いペースで成長すると予測されています。一株当たり利益成長率予想将来の株主資本利益率将来のROE: GSGT.Fの 自己資本利益率 が 3 年後に高くなると予測されるかどうかを判断するにはデータが不十分です成長企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 業界の高成長企業。View Past Performance企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/31 04:25終値2026/06/17 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社のGitHubページでご覧いただけます。また、レポートの活用方法に関するガイドやYouTubeのチュートリアルも用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋GenSight Biologics S.A. 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。8 アナリスト機関Keay NakaeChardan Capital Markets, LLCDaniil GataulinChardan Capital Markets, LLCGbolahan Amusa BenzChardan Capital Markets, LLC5 その他のアナリストを表示
お知らせ • Mar 27Gensight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2025GenSight 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 01GenSight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2024GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2024. For the year, the company expected revenues of EUR 1,500,000; total operating income of EUR 2,625,000; Operating loss of EUR 15,813,000; Net loss of EUR 14,001,000; Basic and diluted loss per share of EUR 0.15; and Total comprehensive loss of EUR 14,172,000.
お知らせ • Apr 14GenSight Biologics S.A., Annual General Meeting, May 19, 2026GenSight Biologics S.A., Annual General Meeting, May 19, 2026. Location: 74 rue du faubourg saint antoine, paris France
お知らせ • Mar 27Gensight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2025GenSight 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 10GenSight Biologics S.A. Provides Updates About GS010/LUMEVOQ Early Access Programs And The Ongoing REVISE StudyGenSight 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 18Gensight Biologics Announces Executive ChangesGenSight 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 10The 15-20 National Hospital and Gensight Biologics Announce the Treatment of the First Patient in the GS010/LUMEVOQ Revise StudyThe 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 08GenSight Biologics S.A. announced that it has received fundingGenSight 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.
お知らせ • Dec 23+ 1 more updateGenSight Biologics S.A. to Report First Half, 2026 Results on Sep 29, 2026GenSight Biologics S.A. announced that they will report first half, 2026 results on Sep 29, 2026
お知らせ • Dec 03GenSight Biologics Announces Regulatory Approval for GS010/LUMEVOQ REVISE Dose-Ranging Study in FranceGenSight Biologics announced that the French medicines safety agency ANSM (Agence nationale de securite du medicament et des produits de sante) has authorized the dose-ranging study REVISE, which will investigate the efficacy and safety of two dose levels of the Company's candidate gene therapy GS010/LUMEVOQ. Two (2) clinical doses will be investigated in the trial, with patients distributed equally over the two doses. Efficacy, as measured by the change in Best Corrected Visual Acuity (BCVA), 1.5 years post-treatment versus baseline, is the primary endpoint in REVISE. The study is expected to begin in January 2026. While the AAC application is under review, GenSight Biologics is moving forward according to target timelines with the final stages of the technology transfer to its new manufacturing partner and with the preparations to finalize the protocol for the Phase III study. In parallel, the Company is pursuing opportunities to out-license GS010 in markets outside the USA and Europe, while exploring paid Early Access Programs worldwide. 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.
お知らせ • Oct 30GenSight Biologics Announces Regulatory Authorizations for Individual Patient Expanded Access Treatment with GS010/LUMEVOQ in the USGenSight Biologics announced that the Company's gene therapy GS010/LUMEVOQ has been granted regulatory authorizations for an Individual Patient Expanded Access in the United States. The authorizations mark the first set of regulatory green lights for the candidate product since the Company's withdrawal of its European marketing authorization application in 2023. FDA authorization was granted for expanded access treatment of one eligible patient, based on an application by a physician at the University of Pittsburgh School of Medicine (UPMC) to the agency. The required approval of the school's Institutional Review Board (IRB) was also granted. The patient is scheduled to be treated in November 2025. GS010/LUMEVoQ is in Phase III of its clinical development as a treatment for the rare blinding disease Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene and has not received marketing authorization in any country. The Company is currently completing the technology transfer to its new manufacturing partner, Catalent, which is expected to be finalized by year-end 2025. The transition will enable the production of new batches in 2026 to address the full scope of projected clinical and early access needs. GenSight Biologics is preparing for the launch in H2 2026 of the pivotal Phase III study RECOVER for GS010/LUMEV OQ, while engaging with the French medicines agency ANSM regarding a dose-ranging study the agency requested in connection with an Early Access Program (AAC) in France.
お知らせ • Jul 24GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €0.5 million.GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €0.5 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 2,941,176 Price\Range: €0.17 Transaction Features: Reserved Share Offering
お知らせ • Jul 04GenSight Biologics S.A. announced that it has received fundingGenSight Biologics S.A. announced a private placement of 1,850,000 pre-funded warrants giving the right to subscribe to 1,850,000 additional ordinary shares on July 3, 2025.
お知らせ • Jun 26GenSight Biologics Announces Significant Milestone in New Manufacturing Partnership with CatalentGenSight Biologics announced the successful transfer of the upstream phase of the manufacturing process for LUMEVOQ®?, the Company's gene therapy candidate product for the rare mitochondrial disease Leber Hereditary Optic Neuropathy (LHON), to its new manufacturing partner, Catalent Inc.
お知らせ • Apr 08GenSight Biologics S.A., Annual General Meeting, May 13, 2025GenSight Biologics S.A., Annual General Meeting, May 13, 2025. Location: 74 rue du faubourg saint antoine, paris France
お知らせ • Mar 07GenSight Biologics S.A. has filed a Follow-on Equity Offering in the amount of €0.860839 million.GenSight Biologics S.A. has filed a Follow-on Equity Offering in the amount of €0.860839 million. Security Name: Ordinary Shares Security Type: Common Stock Securities Offered: 3,829,355 Price\Range: €0.2248 Security Features: Attached Warrants Transaction Features: Subsequent Direct Listing
お知らせ • Mar 01GenSight Biologics S.A. Provides Consolidated Earnings Guidance for the Full Year Ended December 31, 2024GenSight Biologics S.A. provided consolidated earnings guidance for the full year ended December 31, 2024. For the year, the company expected revenues of EUR 1,500,000; total operating income of EUR 2,625,000; Operating loss of EUR 15,813,000; Net loss of EUR 14,001,000; Basic and diluted loss per share of EUR 0.15; and Total comprehensive loss of EUR 14,172,000.
お知らせ • Jan 24+ 1 more updateGenSight Biologics S.A. to Report Fiscal Year 2024 Final Results on Mar 19, 2025GenSight Biologics S.A. announced that they will report fiscal year 2024 final results on Mar 19, 2025
お知らせ • Jan 15GenSight Biologics Announces Publication of 5-Year Outcomes for Patients Treated Unilaterally with LUMEVOQ Gene TherapyGenSight Biologics announced the publication of outcomes data from five years’ follow-up of patients treated unilaterally with LUMEVOQ, the company’s investigational gene therapy for Leber Hereditary Optic Neuropathy due to a mutated ND4 mitochondrial gene. The patients had all participated in the Phase III trials RESCUE and REVERSE and accepted enrolling into the long-term study RESTORE at the end of the RESCUE and REVERSE studies. The paper, published online by the leading journal JAMA Ophthalmology in December 2024, found that patients “demonstrated a sustained bilateral improvement in BCVA [Best-Corrected Visual Acuity] and a good safety profile over 5 years after treatment”. The “persistent benefit” continues the durable effect observed at earlier time points and represents a significant addition to the body of evidence on the benefit-risk ratio of LUMEVOQ gene therapy in ND4 LHON patients. When RESTORE participants enrolled in the study, 2 years after the one-time injection, they had already experienced clinically meaningful improvement relative to the lowest point of their Best-Corrected Visual Acuity: +20 ETDRS letters equivalent in their LUMEVOQ®-treated eyes and +17 ETDRS letters equivalent in their sham-treated eyes. Five years after treatment, the bilateral improvement from nadir was sustained, with LUMEVOQ®-treated eyes achieving a mean improvement against nadir of +22 letters equivalent and sham-treated eyes demonstrating a mean improvement of +20 letters equivalent. Responder analyses at Year 5 indicate that improved BCVA was a benefit for a substantial proportion of the study participants. 66.1% of RESTORE participants achieved clinically meaningful (at least +3 lines’ improvement) from nadir in at least one eye, and the proportion rises to 71.0% if the criterion used is Clinically Relevant Recovery against nadir. At the end of the five-year follow-up period, 80.6% of participants had on-chart vision (BCVA = 1.6 LogMAR) in at least one eye. The impact of such results on patients is demonstrated by increases in the self-reported quality of life scores at Year 5 vs. baseline. Clinically significant improvement from baseline was observed in 7 of 10 subscale scores of the NEI VFQ-25 questionnaire used to assess quality of life. The composite score showed a clinically meaningful gain of 7 points from baseline. Safety findings at 5 years post-injection were consistent with previous readouts, which concluded that LUMEVOQ is well-tolerated. The systemic safety was excellent and most ocular events were mild, none were severe or serious, and none led to study discontinuation. RESTORE is one of the larger long-term follow-up studies for a rare disease treatment, with 62 participants accepting the invitation to enroll. All participants were treated with a single intravitreal injection of LUMEVOQ in one eye and with sham injection in the other.
お知らせ • Nov 13GenSight Biologics Announces Submission of LUMEVOQ Dossier to ANSM to Prepare for Restart of Early Access Program in FranceGenSight Biologics S.A. announced the submission of the updated regulatory file for LUMEVOQ gene therapy to the French medicines safety agency Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) to prepare for the restart of the early access (AAC) program in France. The submission documents the successful manufacture of LUMEVOQ, including the blending of two GMP drug substance batches to optimize the number of vials available for clinical use and the passing of all required quality control tests. LUMEVOQ is being developed as a treatment for Leber Hereditary Optic Neuropathy (LHON) caused by a mutated ND4 mitochondrial gene, a rare mitochondrial genetic disease that causes acute and usually irreversible loss of vision. The updated regulatory file will support the ANSM’s assessment of individual applications for compassionate use, which can now be submitted by healthcare professionals under the rules of the AAC program. GenSight Biologics anticipates a review period for these applications and will work closely with the ANSM to optimize the assessment timeline. GenSight Biologics is preparing to initiate the supply of the drug to the designated treatment center, the Quinze-Vingts hospital in Paris, in mid-December. In parallel, the Company is working with the hospital’s administrative and medical teams to enable the first injections to be administered by the end of December.
お知らせ • Jul 23GenSight Biologics S.A. Provides Business UpdateGenSight Biologics S.A. announced that the manufacture of LUMEVOQ drug product, which required an additional blending step to optimize the number of vials available for the early access program, was successfully performed in July as scheduled. Vials from the batch are now being tested for conformity to the required quality control standards. After accounting for testing requirements, over 100 vials could be available for patients. The full set of quality control results are expected in early September. If the quality control criteria are met, the Company expects to be ready to resumption the AAC program in late September 2024. In parallel, the Company has been engaging with the French medicines safety agency ANSM (Agence Nationale de Securite du Medicament et des produits de sante) and working with the Quinze-Vingts Hospital in Paris, France, to prepare for the resumption of the AAC program, as long anticipated by patients.
お知らせ • Jun 05+ 1 more updateGensight Biologics S.A. Appoints William Monteith to Its Board of DirectorsGenSight Biologics announced the appointment of William Monteith to its Board of Directors. Mr. Monteith joined as an independent Director after existing Board members approved his nomination at the meeting on May 29, 2024. William Monteith has over 43 years of experience in both small molecule and large molecule pharmaceutical manufacturing, during which he held increasing positions of responsibility for Operations, Quality and Technical Support. He has been directly involved in the site search, design and build out of 6 pharmaceutical and biotech facilities. While at Wyeth and Sandoz he oversaw the successful implementation of remediation activities for regulatory actions. He was the General Manager for Dendreon when the company became the first to gain approval for and launch an immunotherapy made from a patient’s own cells. He later became the Executive Vice President of Dendreon responsible for the manufacturing, supply chain and the launch of Provenge® in Europe. After the sale of Dendreon to Valeant, he was appointed Chief Operating Officer at Progenitor Cell Therapy, a CDMO that was eventually acquired by Hitachi Chemical. During his role with Hitachi, he oversaw the expansion of their Allendale, NJ, USA, facility as well as the buildout of a cell and gene therapy facility in Yokohama Japan. Upon leaving Hitachi Chemical Advanced Therapies, Bill joined Cellectis as the Vice President Manufacturing, North America where he was responsible for locating a CarT manufacturing facility in North America, eventually overseeing the purchase and build out of a facility in Raleigh, North Carolina. Shortly after the buildout, Bill was appointed the Executive Vice President of Global Operations for Cellectis responsible for operational departments in both Raleigh and Paris. Upon leaving Cellectis, Bill was named Chief Operating Officer for Stridebio, a research development company focused on AAV products for rare diseases. There he was responsible for the buildout of the operations departments and a clinical manufacturing facility. Since his retirement, Bill has taken the role of Program Director for the North Carolina Life Sciences Biomanufacturing Forum, a trade organization that advocates for the life sciences companies that operate in the state.
お知らせ • Apr 05GenSight Biologics S.A. to Report First Half, 2024 Final Results on Sep 23, 2024GenSight Biologics S.A. announced that they will report first half, 2024 final results on Sep 23, 2024
お知らせ • Mar 12GenSight Biologics Announces Initial Results from New Meta-Analyses on Visual Outcomes with LUMEVOQ® Gene Therapy at NANOS 2024GenSight Biologics announced initial results of new meta-analyses in Leber Hereditary Optic Neuropathy (LHON), which show those treated with LUMEVOQ® (GS010; lenadogene nolparvovec) gene therapy experienced a rate of visual recovery greater than that of idebenone-treated patients and untreated (natural history) patients. The meta-analyses are the first to focus solely on patients with the m.11778G>A ND4 mutation, which is the most common mutation and one with a poor visual prognosis. The meta-analyses depict a gradient of efficacy of visual recovery with LUMEVOQ® intravitreal gene therapy resulting in greater recovery rates than that of idebenone treatment, and both greater than that in the natural history of the disease. This gradient of recovery, based on the CRR measure of visual improvement, is observed at both eye level and patient level(response in one or both eyes). There is no overlap in confidence intervals when LUMEVOQ® is compared to idebenone and to natural history, indicating a positive difference in visual outcomes.
お知らせ • Mar 06GenSight Biologics Announces Update on Real-World Data from Early Access Programs of LUMEVOQ® Gene Therapy at NANOS 2024GenSight Biologics has unveiled promising findings from recent real-world data gathered through early access programs (EAP). These data reinforce the efficacy and safety of LUMEVOQ® in patients with Leber Hereditary Optic Neuropathy (LHON) stemming from the ND4 mutation (ND4-LHON), corroborating outcomes observed in clinical trials. Notably, patients who received bilateral injections exhibited a remarkable average gain of +23 ETDRS letters in best-corrected visual acuity (BCVA) from nadir, surpassing the gains seen in patients with unilateral injections. These results, presented at the 2024 annual meeting of the North American Neuro-Ophthalmology Society (NANOS), indicate significant visual improvement among a majority of treated patients. Dr. Chiara La Morgia, MD, PhD, emphasized the consistency and robustness of these findings, underlining their relevance for patients grappling with severe vision impairment. With a more comprehensive dataset compared to earlier releases, these analyses offer a definitive perspective on the sustained upward trajectory of mean visual acuity post-treatment, further supporting the viability of lenadogene nolparvovec as a therapeutic option. Additionally, safety assessments aligned with previous clinical studies, affirming the favorable safety profile of LUMEVOQ® with comparable rates of intraocular inflammation events. These promising outcomes herald a new chapter in the treatment landscape for LHON patients, promising hope and tangible benefits for those afflicted with this debilitating condition.
お知らせ • Feb 08GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €5 million.GenSight Biologics S.A. has completed a Follow-on Equity Offering in the amount of €5 million. Security Name: Shares Security Type: Common Stock Securities Offered: 13,061,651 Price\Range: €0.3828 Transaction Features: Subsequent Direct Listing
お知らせ • Jan 26Gensight Biologics S.A. Announces CFO ChangesGenSight Biologics S.A. announced that Thomas Gidoin, Chief Financial Officer since 2015, has resigned, effective January 26, 2024. An interim CFO was appointed until a permanent replacement is recruited.
お知らせ • Jan 17GenSight Biologics Announces Board ChangesThe Board of Directors of GenSight Biologics acknowledged the resignation of Mr. Bernard Gilly from his position as director. The Board of Directors of the Company also announced its decision, after consultation of the Nomination Committee, to co-opt Mrs. Laurence Rodriguez as director for the remainder of Bernard Gilly’s term of office (expiring at the end of the annual shareholders meeting to be held in 2024 to approve the financial statements for the financial year ending December 31, 2023). The co-optation of Laurence Rodriguez will be subject to ratification by the next shareholders’ meeting of the Company. Laurence Rodriguez appointment as Chief Executive Officer became effective on December 21, 2023. She has over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of executive roles. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of various rare disease products developed or acquired by the Company. She joined GenSight Biologics in May 2021 as Head of Operations for France. She handled the early access program in preparation for LUMEVOQ®'s commercialization and created strong relationships with the stakeholders.
お知らせ • Dec 22GenSight Biologics S.A. Announces CEO ChangesGenSight Biologics announced the appointment of Mrs. Laurence Rodriguez, as new Chief Executive Officer. Laurence Rodriguez has over 30 years’ experience in the life sciences industry, including 13 years in the rare diseases business at Sanofi Genzyme, where she held a range of executive roles. As Head of the Rare Diseases & Rare Blood Disorders unit at Sanofi Genzyme, she oversaw the successful launch of various rare disease products developed or acquired by the Company. She joined GenSight Biologics in May 2021 as Head of Operations for France. She handled the early access program in preparation for LUMEVOQ's commercialization and created strong and trustworthy relationships with the various stakeholders. Laurence Rodriguez holds a Bachelor’s degree in Nutrition and Biochemistry and a Master’s degree from Sciences Po, Paris, France, and completed an Organization Leadership Program at the Harvard Business School. The board of directors thanked Bernard Gilly, co-founder of the Company in 2012 together with Pr. José-Alain Sahel, for his many years of dedication to the Company and his essential contribution to make LUMEVOQ a life changing therapy. He will remain a director of the Company while he no longer assumes operational responsibilities.
お知らせ • Nov 17Gensight Biologics S.A. Confirms Second Successful GMP Batch of LumevoqGenSight Biologics S.A. announced that an independent laboratory confirmed the vg titer from the second drug substance (DS) batch of LUMEVOQ manufactured under conditions compliant with Good Manufacturing Practice (GMP) standards. As a result from the confirmation, the Company became eligible to draw down the second tranche of the bridge financing signed in August 2023 with Sofinnova Partners, Invus and UPMC Enterprises (the "Bridge Financing"). The drawdown of the second tranche will also trigger the automatic conversion of the convertible bonds from the €6 million first tranche at a conversion price of EUR 0.7122. This second tranche, amounting to €4 million, will extend the Company’s cash runway to mid-December 2023. GenSight Biologics needs to seek other sources of debt, other non-dilutive or equity financing in order to supplement its working capital requirements and fund its operating expenses beyond that date and until the resumption of the early access program in France (Autorisation d’Accès Compassionnel or AAC) expected in the beginning of the second quarter of 2024. GenSight Biologics estimates that, in addition to the second tranche of the Bridge Financing, it will need approximately €10 million to finance its activities until that date.
お知らせ • Nov 14GenSight Biologics S.A. Announces Preliminary Assay Indicating Successful Manufacture of Second LUMEVOQ® GMP BatchGenSight Biologics S.A. announced that a preliminary assay of the viral genome (vg) titer indicates the successful manufacture of a second batch of drug substance (DS) for LUMEVOQ®, the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. The assay, while preliminary, is known to be predictive of the final result at the independent laboratory used for the official release assay. Because the batch was manufactured according to GMP manufacturing protocols, which are the required standards for commercial batches, the gene therapy from the drug substance of this batch may be eligible for use with patients after passing all quality control tests and pending discussions with regulatory bodies. Preparations are underway for the third GMP batch of the campaign planned by the Company. As with the two batches successfully manufactured so far, all of which are outside the context of a validation campaign1, the third batch will generate more process data for a future Marketing Authorisation Application (MAA) submission, provide more experience of the manufacturing process to the operating teams, and help fulfill the immediate requirement of supplying product for the new RECOVER clinical trial and for the potential resumption of an early access program for patients in the beginning of the second quarter of 2024. GenSight Biologics will communicate further in the next few days when the vg titer results are confirmed by the independent laboratory. Upon this confirmation, the Company would be eligible to drawdown the second tranche of €4 million from the bridge financing signed in August 2023 with Sofinnova Partners, Invus and UPMC Enterprises. The cash runway would be extended to mid-December 2023 with the drawdown of the second tranche of the Bridge Financing for an amount of €4 million. Following the drawdown of the second tranche, GenSight Biologics needs to seek other sources of debt, other non-dilutive or equity financing beyond that date in order to supplement its working capital requirements and fund its operating expenses until the resumption of the early access program in France (Autorisation d’Accès Compassionnel or AAC) expected in the beginning of the second quarter of 2024. GenSight Biologics estimates that, in addition to the second tranche of the Bridge Financing, it will need approximately €10 million to finance its activities until that date.
お知らせ • Sep 27GenSight Biologics Provides Update on European Medicines Agency Scientific Advice for LUMEVOQGenSight Biologics provided an update on the scientific advice it received from the European Medicines Agency (EMA) regarding the design of a new Phase III trial for LUMEVOQ, the Company's gene therapy for LHON caused by a mutated ND4 mitochondrial gene. The new study, which will be called RECOVER, will be a randomized controlled trial with a two-arm design: a sham control arm, in which a sham procedure mimics an injection into each eye but no substance is injected into the eye, and a treatment arm, in which subjects will be given bilateral intravitreal injections of LUMEVOQ (also known as GS010) The Agency found that the "proposed study design with bilateral administration appears acceptable to assess the benefits of GS010 in patients who require both eyes to be treated". The proposed study design also contains an open-label provision, in which subjects in the sham arm will be eligible to receive LUMEVOQ bilateral injection if the primary endpoint is met. The Agency provided further guidance on planned statistical analyses and advised on topics that the Company will consider as it refines and finalizes the study design. The RECOVER study is designed to address the questions raised by the EMA's Committee for Advanced Therapies (CAT) when it reviewed the MAA filed in 2020. The Company decided to withdraw the dossier in April 2023 to be able to discuss the Agency's concerns more fully. RECOVER will be able to begin recruiting once the design is finalized; the product is manufactured and released for human use; and approval is obtained from local competent authorities and ethics committees. GenSight expects to initiate the study in second quarter 2024 and to have it completed by second quarter 2026. GenSight also plans to share key aspects of RECOVER's design with other regulatory authorities such as the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA). An initial discussion with the MHRA is scheduled to take place in November 2023. The Company plans to engage with the FDA in the coming months, so that RECOVER results will be accepted by all major regulatory authorities.
お知らせ • Sep 18GenSight Biologics Announces Successful Manufacture of LUMEVOQ GMP BatchGenSight Biologics announced that the Company's manufacturing partner in the US has successfully manufactured the drug substance (DS) for LUMEVOQ®?, the Company's gene therapy for Leber Hereditary Optic Neuropathy (LHON), compliant with Good Manufacturing Practice (GMP) standards. Because the batch was manufactured according to GMP manufacturing protocols, which are the required standards for commercial batches, the gene therapy may be eligible for use with patients after passing all quality control tests and pending discussions with regulatory bodies. The manufacturing of a second GMP DS batch, which will increase the amount that can be made available to patients, is already underway, with vg titer results expected in October 2023. GenSight is planning to manufacture at least 3 GMP batches at commercial scale outside the context of a validation campaign1, to generate more process data for a future Marketing Authorisation Application (MAA) submission, to provide more experience of the manufacturing process to the operating teams, and to fulfil the immediate requirement of supplying product for a possible new clinical trial and for the potential resumption of an early access program for patients in first quarter of 2024.
お知らせ • Feb 13GenSight Biologics Announces 1 Year Safety Data and Efficacy SignalsGenSight Biologics announced favorable safety data and encouraging efficacy signals at 1 year post-gene therapy administration for the PIONEER Phase I/II clinical trial evaluating GS030 for the treatment of retinitis pigmentosa (RP) in 9 patients, with a follow-up up to 4 years (n=1). RP is a genetic blinding disease that affects between 15,000 and 20,000 new patients each year in the US and the EU for which there is currently no treatment. PIONEER is a first-in-human, multi-center, open-label dose escalation clinical trial evaluating the safety and tolerability of GS030, an optogenetic treatment candidate combining an AAV2- based gene therapy (GS030-DP) with the use of light-stimulating goggles (GS030-MD) in patients with end-stage RP. This therapeutic approach is independent of the causal mutation and therefore applicable to potentially all patients suffering from end-stage RP. Three cohorts of three patients each were administered one of three doses of GS030-DP (5e10 vg; 1.5e11 vg; 5e11 vg) via a single intravitreal injection in their worst affected eye (i.e., the least-seeing eye). A Data Safety Monitoring Board (DSMB) reviewed the safety data of all treated subjects in each cohort and made recommendations before the extension cohort was enrolled. Based on the good safety profile of GS030, the DSMB recommended selecting the highest dose (5e11 vg) for the extension cohort where patients are currently being recruited. The safety and tolerability results in the first three completed cohorts recorded only mild and moderate (grade 1 and 2) ocular adverse events (AEs) but no severe (grade 3) AEs, with a follow-up up to 4 years (n=1). The most common ocular AEs were mild intraocular inflammation responsive to corticosteroid treatment. Intraocular inflammation occurred in 70% of patients and resolved without sequalae in all patients. The first use of GS030-MD was performed 8 weeks after injection under medical supervision and the light-stimulating goggles were well tolerated. Subjects performed multiple training sessions in parallel to scheduled study visits. The patients from the highest dose cohort have reached 1-year post-gene therapy administration, enabling the assessment of efficacy signals at one year for the 3 cohorts. Encouraging signs of efficacy at 1 year were demonstrated in some patients after GS030 optogenetic treatment with a vision that improved from being barely able to perceive light before treatment to being able to locate and count objects, with the best results at the highest dose.