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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) 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.
MeiraGTx Holdings, a clinical stage gene therapy company, announced that Alexandria Forbes, Ph.D., CEO, will present at the Barclays Gene Editing & Gene Therapy Summit on November 16, 2020, at 1:30 p.m. ET. The event can be accessed via a live webcast on the company's investors page. MeiraGTx has a robust pipeline with six clinical programs focusing on unmet medical needs in inherited retinal diseases, neurodegenerative diseases, and severe xerostomia. The company aims to advance innovative gene therapy treatments for these serious health conditions.
MeiraGTx (MGTX) announced robust financial results for Q3 2020, reporting a license revenue increase to $5.1 million from $3.6 million in Q3 2019. The firm is preparing to initiate a Phase 3 trial for AAV-RPGR, showing promising vision improvement from Phase 1/2 data. Despite a net loss of $6.4 million, down from $10.5 million a year prior, cash reserves stand at $179.3 million, sufficient to cover expenses into 2022. Construction of a new plasmid production facility in Ireland is on track for completion by year-end 2020, enhancing manufacturing capabilities.
MeiraGTx Holdings plc (Nasdaq: MGTX) announced the presentation of twelve-month results from its ongoing Phase 1/2 clinical trial of AAV-RPGR, an investigational gene therapy for X-linked retinitis pigmentosa (XLRP), at the American Academy of Ophthalmology 2020 Virtual Meeting from November 13-15, 2020. The data, which will be shared by presenter Michel Michaelides, has shown significant improvements in vision and retinal sensitivity. AAV-RPGR has received FDA Fast Track and Orphan Drug designations, enhancing its development prospects.
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