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 (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.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced a term loan agreement with Perceptive Advisors for up to $100 million, including $75 million immediately available. This minimally dilutive capital, collateralized by manufacturing facilities in London and Shannon, extends the company’s cash runway to Q4 2024. The loan has a 10% interest rate and a maturity date of August 2, 2026. The funds will be used for the development of clinical products and other corporate purposes. The company retains value through its pipeline and manufacturing capabilities, supporting growth in gene therapy.
MeiraGTx Holdings (MGTX) announced positive results from its Phase 1/2 MGT009 clinical study of botaretigene sparoparvovec, an investigational gene therapy for X-linked retinitis pigmentosa (XLRP). The therapy demonstrated a favorable safety profile and significant improvements in retinal function, visual function, and functional vision compared to an untreated control group at six months. The results indicate potential for life-changing impact on patients with XLRP, a condition currently lacking approved treatments. The company is preparing for its Phase 3 Lumeos study while actively enrolling patients.
MeiraGTx Holdings plc (MGTX) reported its Q1 2022 financial results, revealing a license revenue increase to $5.6 million, up from $4.6 million in Q1 2021, mainly due to Janssen collaborations. R&D expenses rose to $23.1 million, reflecting growth in clinical trial costs. The net loss attributable to shareholders was $31 million, compared to $23.6 million a year prior. The company continues to progress its Phase 3 Lumeos trial for X-linked Retinitis Pigmentosa and recently completed the AQUAx study for radiation-induced xerostomia. MeiraGTx maintains a cash reserve of approximately $114 million.
MeiraGTx Holdings announced new clinical data from its Phase 1/2 trial of botaretigene sparoparvovec aimed at treating X-linked Retinitis Pigmentosa (XLRP) at the ARVO 2022 Annual Meeting. Results suggest localized improvements in retinal sensitivity up to 12 months post-treatment. The data indicates that the gene therapy could restore photoreceptor function, with results extending beyond the delivery site. MeiraGTx collaborates with Janssen Pharmaceuticals on this gene therapy, further demonstrating progress in developing treatments for inherited retinal diseases.
MeiraGTx Holdings (NASDAQ:MGTX) has appointed Dr. Debra Yu to its Board of Directors. Dr. Yu brings over 30 years of healthcare experience, previously serving as President and Chief Strategy Officer of LianBio. Her background includes senior positions in business development at Pfizer and venture capital firms. CEO Alexandria Forbes highlighted that Dr. Yu's expertise will provide valuable insights as MeiraGTx, a gene therapy company, continues to expand its operations and product pipeline focusing on ocular, neurodegenerative diseases, and xerostomia.
MeiraGTx Holdings plc (NASDAQ:MGTX) announced participation in several key conferences. Alexandria Forbes, Ph.D. will present at:
- Chardan's 6th Annual Genetic Medicines and Cell Therapy Manufacturing Summit on April 25, 2022
- Mass General Brigham World Medical Innovation Forum on May 4, 2022
- BofA Securities 2022 Healthcare Conference on May 10, 2022
- 2022 RBC Capital Markets Global Healthcare Conference on May 18, 2022
Webcasts will be available on the company's Investor page.
MeiraGTx Holdings plc (MGTX) reported key advancements in its clinical pipeline, including the initiation of Phase 3 trials for botaretigene sparoparvovec in collaboration with Janssen Pharmaceuticals, resulting in a $30 million milestone payment. The company also shared positive preliminary results from the Phase 1 AQUAx trial for AAV-hAQP1, aimed at treating radiation-induced xerostomia, where 6 of 7 patients showed symptom improvement. As of December 31, 2021, MeiraGTx had cash reserves of $137.7 million, ensuring operational funding through mid-2023. However, net losses increased to $79.6 million.
MeiraGTx has announced the receipt of a $30 million milestone payment from Janssen Pharmaceuticals for achieving a clinical milestone in the Phase 3 Lumeos trial of botaretigene sparoparvovec (AAV-RPGR), an investigational gene therapy targeting X-linked retinitis pigmentosa (XLRP). The trial is now actively dosing patients, and the company is also eligible for additional milestone payments related to other gene therapy programs in collaboration with Janssen. XLRP is a severe retinal disease, and this therapy aims to improve vision outcomes for patients.
On December 15, 2021, MeiraGTx Holdings plc (NASDAQ: MGTX) will conduct a virtual R&D Day showcasing its innovative gene regulation platforms. The event, led by CEO Alexandria Forbes, will cover topics such as promoter engineering and synthetic riboswitch technology. Participants can register for the event online and access a live webcast, with a replay available on the company's investor page. MeiraGTx aims to transform gene therapy with its proprietary platforms that promise precise gene expression control, targeting ocular, neurodegenerative diseases, and xerostomia.