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 (Nasdaq: MGTX) will participate in a fireside chat at the Chardan Virtual Genetic Medicines Manufacturing Summit on April 26, 2021, at 1:45 p.m. ET. The discussion will feature CEO Alexandria Forbes and CDO Stuart Naylor.
A live webcast will be available on the company’s Investors page, and a replay will be accessible for 90 days post-event. MeiraGTx is focused on gene therapy solutions for inherited retinal diseases, neurodegenerative conditions, and xerostomia.
MeiraGTx Holdings announced significant progress in its clinical programs and operational results for 2020. Highlights include positive preliminary data from its Phase 1 AQUAx trial for xerostomia and the upcoming Phase 3 Lumeos trial for AAV-RPGR. The company strengthened its balance sheet with $209 million in cash and extended its cash runway into mid-2023. MeiraGTx also reported a net loss of $58 million for 2020, despite an increase in license revenue from collaborations. The new cGMP plasmid and DNA manufacturing facility adds to their capabilities for clinical development.
MeiraGTx Holdings (Nasdaq: MGTX) announced that CEO Alexandria Forbes will present at the Barclays Global Healthcare Conference on March 11, 2021, at 11:30 a.m. ET. A live webcast will be available on the Company’s investor website, with a replay accessible for 30 days post-presentation.
MeiraGTx is a clinical stage gene therapy company with six clinical programs addressing unmet medical needs in inherited retinal diseases, neurodegenerative diseases, and xerostomia. The company focuses on viral vector design and gene therapy manufacturing.
MeiraGTx Holdings Plc (NASDAQ:MGTX) has announced that the FDA granted Fast Track designation to its AAV-CNGA3 gene therapy for achromatopsia (ACHM) caused by mutations in the CNGA3 gene. This designation facilitates expedited development and review of drugs addressing serious conditions. Currently, MeiraGTx is conducting a Phase 1/2 clinical trial for AAV-CNGA3. This is the third Fast Track designation for the company’s retinal disease products, emphasizing the high unmet medical need for effective therapies in this area.
MeiraGTx Holdings (Nasdaq: MGTX) will hold a webcast and conference call on December 17, 2020, at 8:00 a.m. ET to discuss the AAV-hAQP1 clinical program targeting radiation-induced xerostomia. They will share results from the first cohort of three patients in the Phase 1 AQUAx clinical trial, where one patient exhibited complete symptom resolution at the 12-month mark. The treatment showed good tolerance with no serious adverse effects. This update will feature insights from key presenters, including CEO Alexandria Forbes and trial investigator Dr. Michael Brennan.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced that CEO Alexandria Forbes, Ph.D., will present at the Evercore ISI 3rd Annual HealthCONx Conference on December 3, 2020, at 10:05 a.m. ET. The presentation will be available via a live webcast on the company's Investors page. MeiraGTx is a clinical-stage gene therapy company with six programs in development, focusing on inherited retinal diseases, neurodegenerative diseases, and severe forms of xerostomia. The company aims to address significant medical needs through innovative gene therapy solutions.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced that Dr. Alexandria Forbes, CEO, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. The chat is pre-recorded and accessible on the Company's investor website, with a replay available for 90 days. MeiraGTx is a clinical stage gene therapy company focusing on inherited retinal diseases, neurodegenerative diseases, and xerostomia, with a strong pipeline and innovative gene regulation technology.
MeiraGTx Holdings plc (Nasdaq:MGTX) announced a public offering of 5,000,000 ordinary shares priced at $12.85 each, with expected gross proceeds of approximately $64.3 million. The underwriters also have a 30-day option to purchase an additional 750,000 shares. The offering is anticipated to close around November 23, 2020. The shares are offered under an effective registration statement previously filed with the SEC. The press release highlights potential risks and uncertainties related to the company's financial performance and market conditions.
MeiraGTx Holdings plc (NASDAQ:MGTX) announced a public offering of 5,000,000 ordinary shares, with a potential additional sale of 750,000 shares by underwriters. The offering is being managed by BofA Securities, Piper Sandler, Evercore ISI, Barclays, and Chardan. Proceeds will fund general corporate purposes, including working capital. This follows an effective shelf registration with the SEC from 2019. The final offering terms will be disclosed later. The company highlighted that the offering is subject to market conditions, and there are no guarantees of completion.
MeiraGTx Holdings (Nasdaq: MGTX) recently presented encouraging data at the AAO 2020 Virtual Annual Meeting, revealing sustained improvements in retinal sensitivity for patients with X-linked retinitis pigmentosa (XLRP) after 12 months of treatment with AAV-RPGR, an investigational gene therapy. In the Phase 1/2 trial, six of seven patients showed stable or improved vision. The trial's primary focus is safety, with plans for a pivotal Phase 3 trial in collaboration with Janssen Pharmaceuticals.