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 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.
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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.