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 clinical-stage leader in gene therapy innovation, developing transformative treatments for ocular, neurological, and salivary gland disorders. This dedicated news hub provides investors and industry professionals with timely updates on the company’s progress, regulatory milestones, and strategic initiatives.
Access authoritative information directly from corporate announcements and verified sources. Track developments across MeiraGTx’s pipeline including clinical trial results for inherited retinal diseases, Parkinson’s disease research updates, and advancements in radiation-induced xerostomia therapies. The repository also features financial disclosures, manufacturing expansions, and partnership announcements.
Key updates include progress on the company’s proprietary riboswitch platform, AAV vector manufacturing innovations, and regulatory interactions. All content is curated to support informed analysis of MeiraGTx’s position in the gene therapy landscape while maintaining strict compliance with financial reporting standards.
Bookmark this page for streamlined access to essential MGTX updates. Combine our news tracking with Stock Titan’s analysis tools to monitor the company’s progress in advancing genetic medicines from clinical development to potential commercialization.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced two abstract presentations at the ARVO 2023 Annual Meeting. The first presentation covers the humoral immune response data from the Phase 1/2 MGT009 trial of botaretigene sparoparvovec (bota-vec), aimed at treating X-linked retinitis pigmentosa (XLRP) caused by RPGR gene mutations. This therapy is being developed in partnership with Janssen Pharmaceuticals.
The second focus is on AI-assisted engineered promoters to enhance gene expression in rod photoreceptors. Alexandria Forbes, Ph.D., highlighted the importance of these findings for advancing treatment options for XLRP, which currently has no approved therapies. The presentations will take place on April 23 and 27, 2023, at specific sessions.
MeiraGTx Holdings plc (NASDAQ:MGTX) announced that its CEO, Alexandria Forbes, Ph.D., will participate in several upcoming investor conferences. Key events include:
- Chardan's 7th Annual Genetic Medicines and Cell Therapy Manufacturing Summit - April 24, 2023, at 2:30 p.m. ET
- Panel Discussion: Gene Therapy: Positioning for CMC Success - April 25, 2023, at 12:00 p.m. ET
- BofA Securities 2023 Healthcare Conference - May 10, 2023, at 2:35 p.m. PT
- RBC Capital Markets 2023 Global Healthcare Conference - May 17, 2023, at 10:00 a.m. ET
Live webcasts will be accessible on MeiraGTx's Investors page, with replays available for 30 days post-event. MeiraGTx is focused on gene therapy for ocular and neurodegenerative diseases.
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.
