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MeiraGTx Holdings plc (Nasdaq: MGTX) is a vertically integrated, clinical-stage gene therapy company with a focus on transforming the lives of patients through innovative genetic medicines. Based in London and New York, MeiraGTx pioneers gene therapies for a range of acquired and inherited disorders. The company's research spans serious neurodegenerative diseases such as Alzheimer's, Parkinson's, and ALS, as well as ocular diseases like inherited blindness and age-related macular degeneration. Additionally, MeiraGTx is developing treatments for xerostomia, a debilitating side effect of head and neck cancer radiation therapies.
MeiraGTx's product pipeline includes several advanced-stage clinical trials and preclinical research programs aimed at addressing significant unmet medical needs. Key pipeline products include AAV-CNGB3, AAV-CNGA3, and AAV-RPGR. These therapies target eye disorders, central nervous system conditions, and salivary gland dysfunctions.
The company has gained notable recognition and strategic investments from major pharmaceutical entities. Recently, Sanofi made a $30 million strategic investment in MeiraGTx, validating its Riboswitch gene regulation technology and xerostomia program. This investment underscores the broad potential of MeiraGTx's platform, which supports the development of breakthrough medicines for neurodegenerative and immune-mediated diseases.
MeiraGTx is also advancing its gene therapy manufacturing capabilities, with facilities in the United States, the United Kingdom, and the European Union. The company boasts state-of-the-art viral vector design and optimization, as well as a transformative gene regulation platform technology that allows precise, dose-responsive control of gene expression through oral small molecules.
Financially, MeiraGTx is well-positioned with a robust cash balance, strategic partnerships, and a strong pipeline of potential milestone payments. The company recently reported a $50 million milestone payment from Janssen Pharmaceuticals following the initiation of an extension study for the Phase 3 LUMEOS clinical trial for botaretigene sparoparvovec (bota-vec) for X-linked retinitis pigmentosa.
With a dedicated management team and a comprehensive end-to-end manufacturing infrastructure, MeiraGTx is poised to bring innovative genetic therapies to market, addressing both rare and prevalent diseases. For more information, visit www.meiragtx.com.
MeiraGTx (MGTX) announced robust financial results for Q3 2020, reporting a license revenue increase to $5.1 million from $3.6 million in Q3 2019. The firm is preparing to initiate a Phase 3 trial for AAV-RPGR, showing promising vision improvement from Phase 1/2 data. Despite a net loss of $6.4 million, down from $10.5 million a year prior, cash reserves stand at $179.3 million, sufficient to cover expenses into 2022. Construction of a new plasmid production facility in Ireland is on track for completion by year-end 2020, enhancing manufacturing capabilities.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced the presentation of twelve-month results from its ongoing Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for X-linked retinitis pigmentosa (XLRP), at the American Academy of Ophthalmology 2020 Virtual Meeting from November 13-15, 2020. The data, which will be shared by presenter Michel Michaelides, has shown significant improvements in vision and retinal sensitivity. AAV-RPGR has received FDA Fast Track and Orphan Drug designations, enhancing its development prospects.
MeiraGTx Holdings plc (MGTX) presented nine-month data from its Phase 1/2 clinical trial of AAV-RPGR, a gene therapy for X-linked retinitis pigmentosa, at the EURETINA 2020 Virtual Congress. The results showed significant improvements in retinal sensitivity and vision-guided mobility compared to untreated eyes. Specifically, six out of seven patients in low and intermediate dose cohorts maintained or improved retinal sensitivity. The therapy is well-tolerated, with plans to advance into a Phase 3 pivotal study following the ongoing success.
MeiraGTx (Nasdaq: MGTX), a clinical stage gene therapy company, announces that CEO Alexandria Forbes, Ph.D., will present at the Chardan 4th Annual Genetic Medicines Conference on October 5, 2020, at 1:30 p.m. ET. A live webcast of the event will be available on the company's Investors page, with a replay accessible for 30 days post-presentation.
MeiraGTx focuses on developing therapies for unmet medical needs in inherited retinal diseases, neurodegenerative diseases, and severe xerostomia, and boasts a robust pipeline of clinical and preclinical programs.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced that CEO Alexandria Forbes, Ph.D., will present at the Chardan 4th Annual Genetic Medicines Conference on October 5, 2020, at 1:30 p.m. ET. A live webcast will be available on the company's investor webpage, with a replay accessible for 30 days after the event. MeiraGTx is a clinical-stage gene therapy company focusing on unresolved medical needs in inherited retinal diseases, neurodegenerative diseases, and xerostomia, with six clinical development programs and strong capabilities in viral vector design and gene therapy manufacturing.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced significant progress in its Phase 1/2 clinical trial of AAV-RPGR, a gene therapy for X-linked retinitis pigmentosa (XLRP). The latest data, to be presented at the EURETINA 2020 Virtual Meeting on October 3, showcases nine-month results indicating positive outcomes in vision improvement and safety. AAV-RPGR, developed in collaboration with Janssen, targets RPGR gene mutations, which are responsible for over 70% of XLRP cases. The therapy has received several designations, including Fast Track and Orphan Drug by the FDA.
MeiraGTx Holdings plc (MGTX) announced its Q2 2020 results, highlighting positive initial data from the Phase 1/2 trial of AAV-RPGR for X-linked retinitis pigmentosa, leading to its advancement into the Phase 3 Lumeos trial. The company also unveiled plans for new manufacturing facilities in Shannon, Ireland, set to enhance production capabilities. Financially, MeiraGTx reported a net loss of $25.4 million and cash reserves of $194.8 million. License revenue increased to $2.5 million, while R&D expenses rose to $16.2 million, influenced by costs from clinical trials and a recent acquisition.
MeiraGTx Holdings (MGTX) announced positive results from the Phase 1/2 clinical trial of AAV-RPGR, aimed at treating X-linked retinitis pigmentosa (XLRP). Significant improvements in vision were observed in patients after six months, with favorable safety and efficacy profiles noted. As a result, MeiraGTx and Janssen plan to progress AAV-RPGR into the Phase 3 Lumeos trial. The findings were presented at the ASRS 2020 Virtual Annual Meeting, highlighting the potential of AAV-RPGR as a significant advancement in treating a disease currently lacking approved therapies.
MeiraGTx Holdings plc (MGTX) reported Q1 2020 financial results, highlighting a net loss of $15.7 million, or $0.43 per share, an improvement from $18 million, or $0.62 per share, in Q1 2019. The company had cash, cash equivalents, and restricted cash totaling approximately $211 million, sufficient to fund operations into 2022. License revenue rose to $4.2 million, driven by a collaboration agreement with Janssen. R&D expenses decreased to $8.1 million, while G&A expenses increased to $11.8 million. MeiraGTx remains focused on its clinical programs despite COVID-19 challenges.
MeiraGTx Holdings plc (Nasdaq: MGTX), a clinical stage gene therapy company, will have its CEO, Alexandria Forbes, present at the Virtual Bank of America Securities 2020 Health Care Conference on May 12, 2020, at 10:20 a.m. ET. Interested parties can access the live webcast on the Company's Investors page, with a replay available for 30 days. MeiraGTx specializes in gene therapies targeting inherited retinal diseases, neurodegenerative diseases, and xerostomia, supported by a strong pipeline and advanced manufacturing capabilities.
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