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MeiraGTx Holdings plc (Nasdaq: MGTX) is a vertically integrated, clinical-stage gene therapy company with a focus on transforming the lives of patients through innovative genetic medicines. Based in London and New York, MeiraGTx pioneers gene therapies for a range of acquired and inherited disorders. The company's research spans serious neurodegenerative diseases such as Alzheimer's, Parkinson's, and ALS, as well as ocular diseases like inherited blindness and age-related macular degeneration. Additionally, MeiraGTx is developing treatments for xerostomia, a debilitating side effect of head and neck cancer radiation therapies.
MeiraGTx's product pipeline includes several advanced-stage clinical trials and preclinical research programs aimed at addressing significant unmet medical needs. Key pipeline products include AAV-CNGB3, AAV-CNGA3, and AAV-RPGR. These therapies target eye disorders, central nervous system conditions, and salivary gland dysfunctions.
The company has gained notable recognition and strategic investments from major pharmaceutical entities. Recently, Sanofi made a $30 million strategic investment in MeiraGTx, validating its Riboswitch gene regulation technology and xerostomia program. This investment underscores the broad potential of MeiraGTx's platform, which supports the development of breakthrough medicines for neurodegenerative and immune-mediated diseases.
MeiraGTx is also advancing its gene therapy manufacturing capabilities, with facilities in the United States, the United Kingdom, and the European Union. The company boasts state-of-the-art viral vector design and optimization, as well as a transformative gene regulation platform technology that allows precise, dose-responsive control of gene expression through oral small molecules.
Financially, MeiraGTx is well-positioned with a robust cash balance, strategic partnerships, and a strong pipeline of potential milestone payments. The company recently reported a $50 million milestone payment from Janssen Pharmaceuticals following the initiation of an extension study for the Phase 3 LUMEOS clinical trial for botaretigene sparoparvovec (bota-vec) for X-linked retinitis pigmentosa.
With a dedicated management team and a comprehensive end-to-end manufacturing infrastructure, MeiraGTx is poised to bring innovative genetic therapies to market, addressing both rare and prevalent diseases. For more information, visit www.meiragtx.com.
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.
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.
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.
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