Welcome to our dedicated page for Meiragtx Holdings Plc news (Ticker: MGTX), a resource for investors and traders seeking the latest updates and insights on Meiragtx Holdings Plc stock.
MeiraGTx Holdings plc (Nasdaq: MGTX) is a vertically integrated, clinical-stage genetic medicines company. Its news flow centers on clinical trial readouts, regulatory designations, strategic collaborations and manufacturing milestones across a broad pipeline in ophthalmology, Parkinson’s disease, radiation-induced xerostomia and other genetic medicine programs.
News updates from MeiraGTx frequently cover progress in late-stage clinical programs such as AAV-AIPL1 for Leber congenital amaurosis 4, AAV2-hAQP1 for radiation-induced xerostomia and AAV-GAD for Parkinson’s disease. The company issues releases on data presented at scientific meetings, including results from randomized, double-blind, sham-controlled studies and first-in-human trials in rare pediatric retinal dystrophies.
Investors and observers can also follow announcements about regulatory interactions, including Regenerative Medicine Advanced Therapy (RMAT) designations, orphan and Rare Pediatric Disease designations, and plans for marketing authorization applications and biologics license applications in the United States, United Kingdom and European Union. These items provide context on potential development pathways for MeiraGTx’s investigational therapies.
Another recurring theme in MeiraGTx news is strategic partnering. The company has reported a collaboration and license agreement with Eli Lilly and Company in ophthalmology, as well as a broad collaboration with Hologen AI that includes the formation of Hologen Neuro AI Ltd to advance AAV-GAD and other central nervous system programs. Updates on its relationship with Johnson & Johnson Innovative Medicine around botaretigene sparoparvovec for X-linked retinitis pigmentosa also appear in its news feed.
In addition, MeiraGTx news items highlight developments in its riboswitch gene regulation platform, promoter and capsid engineering research, and expansions of its GMP manufacturing capabilities in the United Kingdom and Ireland. Visitors to this page can review these releases to understand how MeiraGTx’s clinical, regulatory, technological and manufacturing activities evolve over time.
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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