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 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 Holdings plc (Nasdaq: MGTX) announced its fourth quarter and full-year financial results for 2022. They reported cash and equivalents of approximately $115 million and a decrease in license revenue from $37.7 million in 2021 to $15.9 million in 2022.
Significant clinical advancements were noted, including positive Phase 1 trial data for AAV-hAQP1 targeting radiation-induced xerostomia and encouraging top-line results from the MGT009 study in X-linked retinitis pigmentosa (XLRP). The company aims for a BLA submission for XLRP in 2024 and plans new trials for both xerostomia and Parkinson's disease.
MeiraGTx Holdings (NASDAQ: MGTX) announced positive clinical results from its Phase 1 AQUAx study of AAV2-hAQP1 for treating radiation-induced xerostomia. Key findings show significant improvements in xerostomia symptoms and saliva flow rates in both unilateral and bilateral cohorts. The therapy demonstrated safety and durability of effects, with improvements lasting up to 3 years. Plans are underway to advance to a Phase 2 study in 2023. Current treatment options for this condition are limited, highlighting a significant unmet need.
MeiraGTx Holdings (MGTX) will hold a conference call on December 13, 2022, at 8:00 a.m. ET to present clinical data from its Phase 1 AQUAx trial for treating radiation-induced xerostomia. The call will include a safety update, patient-reported outcomes, and saliva flow measurements for 24 treated patients. Results will feature 12-month data for unilateral cohorts and 6-month data for bilateral cohorts, along with long-term data for some subjects. This trial aims to establish the safety and efficacy of AAV-hAQP1 gene therapy, targeting patients post-head and neck cancer treatment.
MeiraGTx Holdings (NASDAQ:MGTX) announced participation in three investor conferences. CEO Alexandria Forbes will engage in fireside chats: on November 29, 2022, at the Piper Sandler 34th Annual Healthcare Conference in New York, December 1, 2022, at Evercore ISI's HealthCONx Conference, and December 7, 2022, at the BofA 2022 Smid Cap Biotech Conference. Live webcasts of these discussions will be accessible via the company’s Investors page. MeiraGTx focuses on gene therapy with programs addressing ocular, neurodegenerative diseases, and xerostomia.
MeiraGTx Holdings announced its Q3 2022 financial results, reporting a net loss of $37.3 million. The company received a $25 million investment from Johnson & Johnson's innovation arm. Progress in clinical trials includes ongoing dosing for botaretigene sparoparvovec for X-linked Retinitis Pigmentosa and the initiation of a Phase 1 trial for AAV-GAD gene therapy for Parkinson's disease. License revenue decreased to $4.8 million, while research and development expenses decreased to $16.9 million, despite a significant foreign currency loss of $12.8 million.
MeiraGTx Holdings announced positive results from the Phase 1/2 MGT009 study of botaretigene sparoparvovec for treating X-linked retinitis pigmentosa (XLRP) at the 2022 AAO Annual Meeting. The therapy demonstrated an acceptable safety profile and effective improvements in retinal sensitivity, visual function, and overall vision at six months post-treatment. Currently, the program is progressing to the Phase 3 LUMEOS trial, actively enrolling patients. This therapeutic approach aims to replace a defective gene to restore vision, targeting an unmet need in the XLRP patient population.
MeiraGTx Holdings plc (NASDAQ: MGTX) unveiled its GMP manufacturing facility in Shannon, Ireland, making it the first commercial-scale gene therapy site in the country. Covering 150,000 square feet, the facility integrates viral vector production, plasmid DNA manufacturing, and Quality Control (QC). This development enables accelerated gene therapy treatments for various serious diseases. It aims to reduce clinical development bottlenecks and regulatory risks while cutting costs. The site, employing 100 staff initially, can expand to over 300, supporting collaboration with leading local bioscience institutions.
MeiraGTx Holdings (NASDAQ:MGTX) announced participation in two upcoming investor conferences. CEO Alexandria Forbes will engage in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 14, 2022, at 3:30 p.m. ET. She will also participate in a panel on Gene Regulation and a subsequent fireside chat at Chardan's 6th Annual Genetic Medicines Conference on October 4, 2022. Live webcasts and replays of the discussions will be available on the company's investor website.
MeiraGTx Holdings plc (MGTX) reported positive topline data from its Phase 1/2 trial of botaretigene sparoparvovec for X-linked retinitis pigmentosa, showing improvements in vision across multiple endpoints. The company secured a financing deal of up to $100 million, extending its cash runway to Q4 2024. Financial results for Q2 2022 revealed license revenue of $10.8 million, up from $5.1 million in Q2 2021. However, the net loss for Q2 2022 was $34 million, significantly higher than the $20.1 million loss in the same period last year.
FAQ
What is the current stock price of Meiragtx Holdings Plc (MGTX)?
What is the market cap of Meiragtx Holdings Plc (MGTX)?
What does MeiraGTx Holdings plc specialize in?
Where is MeiraGTx Holdings plc based?
What recent strategic investment did MeiraGTx receive?
What are some key products in MeiraGTx's pipeline?
What was the recent milestone payment MeiraGTx received?
What is MeiraGTx’s Riboswitch gene regulation technology?
What diseases is MeiraGTx targeting with its gene therapies?
What is the significance of the Sanofi investment in MeiraGTx?
Does MeiraGTx have its own manufacturing facilities?
Where can I find more information about MeiraGTx's clinical trials?
