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 (MGTX) reported promising preliminary data from its Phase 1 AQUAx trial of AAV-hAQP1, aimed at treating grade 2/3 radiation-induced xerostomia (RIX). The results indicate that 6 out of 7 participants showed clinically meaningful improvement in xerostomia symptoms at 90 days. One participant maintained improvement at 24 months. AAV-hAQP1 demonstrated good safety and tolerability. The company plans to initiate a Phase 2 study in late 2022. RIX affects about 170,000 patients in the U.S., revealing a significant unmet medical need.
MeiraGTx Holdings plc (NASDAQ: MGTX) announced a conference call on December 7, 2021, to discuss updates on its Phase 1 AQUAx clinical trial targeting radiation-induced xerostomia. Additionally, a virtual R&D Day will occur on December 15, 2021, focusing on their gene regulation platforms. The AQUAx trial evaluates AAV-hAQP1's safety and its efficacy in improving salivary output in patients post-radiation therapy. The company is pioneering riboswitch gene regulation technology, aiming to address unmet medical needs across multiple areas, including ocular and neurodegenerative diseases.
MeiraGTx Holdings plc (Nasdaq: MGTX) reported its Q3 2021 financial results, revealing a license revenue of $6.9 million, up from $5.1 million in Q3 2020. The net loss for the quarter was $25.9 million, or $0.59 per share, compared to a loss of $6.4 million last year. The company is progressing its Phase 3 Lumeos Trial and the AQUAx Phase 1 study, while also presenting advancements in its riboswitch gene regulation platform. Despite increased R&D expenses of $21.6 million, MeiraGTx has $143.6 million in cash, sufficient for operations into Q2 2023.
MeiraGTx Holdings (NASDAQ: MGTX), a clinical stage gene therapy company, announced participation in upcoming virtual investor conferences. Key presentations include:
- Barclays Gene Editing & Gene Therapy Summit on November 15, 2021, at 2:00 p.m. ET.
- 33rd Annual Piper Sandler Healthcare Conference available from November 22 to December 2, 2021.
- Evercore ISI 4th Annual HealthCONx on November 30, 2021, at 10:05 a.m. ET.
Webcasts of these events will be accessible on their Investors page for 30 days post-presentation.
Summary not available.
MeiraGTx Holdings (Nasdaq: MGTX) announced that CEO Alexandria Forbes, Ph.D., will present at the virtual Chardan 5th Annual Genetic Medicines Conference on October 5, 2021, at 10:30 a.m. ET. Additionally, Dr. Forbes will participate in a panel titled “The Next Big Thing in Vector Gene Therapy—Non-traditional Vectors and Gene Regulation” at 9:30 a.m. ET on the same day.
A live webcast of the presentation will be available on the company's investor page for 30 days.
MeiraGTx is focused on gene therapy for inherited retinal diseases, neurodegenerative diseases, and xerostomia.
MeiraGTx Holdings plc (MGTX) announced new data from its Phase 1/2 trial regarding AAV5-RPGR, a gene therapy for X-linked retinitis pigmentosa (XLRP). Results show that 12 months post-treatment, retinal function improvement was observed, reversing disease progression in treated subjects. The therapy, developed in collaboration with Janssen Pharmaceuticals, was presented at the EURETINA 2021 Virtual Meeting. The company is also preparing for the pivotal Phase 3 Lumeos clinical trial. AAV5-RPGR has received Fast Track and Orphan Drug designations from the FDA.
MeiraGTx Holdings plc (Nasdaq: MGTX) reported its Q2 financial results for 2021, highlighting significant advancements in its clinical programs. The company's license revenue increased to $5.1 million, up from $2.5 million YoY, partly due to a collaboration with Janssen Pharmaceuticals. R&D expenses decreased to $15.2 million from $16.2 million, while net loss improved to $20.1 million, compared to $25.4 million the previous year. Cash on hand was $172.6 million, providing sufficient capital to sustain operations through Q2 2023. Upcoming trials for XLRP and other indications are set to begin in late 2021.
MeiraGTx Holdings plc (MGTX) reported its Q1 2021 financial results, highlighting a cash position of $199.4 million. The company is advancing its gene therapy programs, with preparations for two Phase 3 trials in X-linked retinitis pigmentosa and RPE65-associated retinal dystrophy. Research and development expenses rose to $16.7 million, up from $8.1 million the previous year, largely due to trial expansions. The net loss increased to $23.6 million, compared to $15.7 million in Q1 2020. MeiraGTx expects sufficient capital to fund operations through mid-2023.
MeiraGTx Holdings (Nasdaq: MGTX) announced that CEO Alexandria Forbes, Ph.D., will speak at several key conferences in May 2021. The events include the BofA Securities 2021 Virtual Health Care Conference on May 12, the RBC Capital Markets Global Healthcare Conference on May 19, and Oppenheimer's Rare & Orphan Disease Summit on May 21. Live webcasts will be available on the Company’s Investors page. MeiraGTx focuses on gene therapies for inherited retinal diseases, neurodegenerative diseases, and severe xerostomia, with multiple programs in clinical development.