| MeiraGTx Announces the Presentation of Four Posters at the American Society of Gene and Cell Therapy (ASGCT) 2025 Annual Meeting |
Multiple Poster Presentations Highlight the Depth and Novelty of MeiraGTx's Technology Platforms for Gene and Cell Therapy Multiple Poster Presentations Highlight the Depth and Novelty of MeiraGTx's Technology Platforms for Gene and Cell Therapy |
globenewswire.com |
2025-05-13 20:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Holdings PLC (MGTX) Reports Q1 Loss, Misses Revenue Estimates |
MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.51 per share versus the Zacks Consensus Estimate of a loss of $0.38. This compares to loss of $0.77 per share a year ago. |
zacks.com |
2025-05-13 14:15:55 |
Czytaj oryginał (ang.) |
| MeiraGTx Reports First Quarter 2025 Financial and Operational Results |
- Announced strategic collaboration with Hologen AI, including a $200 million cash upfront payment to MeiraGTx and the formation of a joint venture, Hologen Neuro AI Ltd, with a further $230 million in capital committed to initially focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson's disease - U.S. Food and Drug Administration (FDA) Granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson's disease - Gained alignment with FDA on the ongoing Phase 2 AQUAx2 randomized double-blind, placebo-controlled pivotal study in Grade 2/3 radiation-induced xerostomia (RIX) to support a potential BLA filing - Efficacy data of rAAV8.hRKp.AIPL1 for the treatment of AIPL1-related retinal dystrophy, or LCA4, published in The Lancet, demonstrating meaningful responses in 11 out of 11 LCA4 children treated. Filing for Marketing Authorization Approval (MAA) under exceptional circumstances with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and in discussions with the FDA around a potentially similar pathway to approval in the US LONDON and NEW YORK, May 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced financial and operational results for the first quarter ended March 31, 2025, and provided a corporate update. |
globenewswire.com |
2025-05-13 12:00:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV-GAD for the Treatment of Parkinson's Disease |
- This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson's disease - RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, May 09, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV-GAD for the treatment of Parkinson's disease not adequately controlled with anti-Parkinsonian medications. This RMAT was awarded following the presentation to the FDA of positive data from 3 clinical studies demonstrating the benefit of AAV-GAD when administered in a one-time stereotactic infusion to the subthalamic nucleus in the brain. |
globenewswire.com |
2025-05-09 12:00:00 |
Czytaj oryginał (ang.) |
| Cone Rod Dystrophy Market Report 2025-2030, with Profiles of SparingVision, Beacon Therapeutics, Nanoscope Therapeutics, MeiraGTx, Ascidian Therapeutics, jCyte, BlueRock Therapeutics and more |
The global cone rod dystrophy market, valued at US$131.29 million in 2024, is projected to reach US$177.59 million by 2030, growing at a CAGR of 5.33%. Key drivers include advancements in gene therapies, personalized medicine, and government programs. North America remains the largest market, while Asia Pacific leads growth. Major players like SparingVision and Beacon Therapeutics propel innovation through ongoing clinical trials. The global cone rod dystrophy market, valued at US$131.29 million in 2024, is projected to reach US$177.59 million by 2030, growing at a CAGR of 5.33%. Key drivers include advancements in gene therapies, personalized medicine, and government programs. North America remains the largest market, while Asia Pacific leads growth. Major players like SparingVision and Beacon Therapeutics propel innovation through ongoing clinical trials. |
globenewswire.com |
2025-04-29 11:11:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Holdings: Gaining Regulatory Focus |
MeiraGTx (MGTX) develops gene therapies for ocular diseases, Parkinson's Disease, and xerostomia, with multiple assets in advanced clinical stages showing promising efficacy and safety data. MGTX uses AAV5 capsid vectors and riboswitch technology to deliver gene therapies, aiming for safer and more controlled treatments compared to earlier approaches. Financially, MGTX has a strong cash position bolstered by a $200mn deal with Hologen, providing a substantial runway for continued development. |
seekingalpha.com |
2025-03-25 12:50:36 |
Czytaj oryginał (ang.) |
| MeiraGTx Collaborates With Hologen AI To Expedite Development Of Parkinson's Candidate, Stock Soars |
On Thursday, MeiraGTx Holdings plc MGTX announced a broad strategic collaboration with Hologen Limited, a developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development. |
benzinga.com |
2025-03-13 11:51:11 |
Czytaj oryginał (ang.) |
| MeiraGTx Reports Fourth Quarter and Full Year 2024 Financial and Operational Results and Recent Business Updates |
- Today announced strategic collaboration with Hologen AI, including a $200 million upfront payment to MeiraGTx and the formation of a joint venture, Hologen Neuro AI Ltd, with a further $230 million in capital committed to initially focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson's disease - MeiraGTx and Hologen have created the first neuro-AI clinical drug development company to transform the discovery and development of therapies targeting CNS circuitry in neurodegenerative and neuropsychiatric disorders - Announced positive data from randomized, double blind, sham-controlled clinical bridging study of AAV-GAD for the treatment of Parkinson's disease demonstrating significant benefits in Unified Parkinson's Disease Rating Scale (UPDRS) Part 3 and Parkinson's Disease Questionnaire (PDQ-39) - Granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for AAV2-hAQP1 for the treatment of Grade 2/3 radiation-induced xerostomia (RIX) - Efficacy data of rAAV8.hRKp.AIPL1 for the treatment of LCA4 published in The Lancet ; unprecedented responses observed in 100% of LCA4 children and MeiraGTx intends to submit a Marketing Authorization Application (MAA) under exceptional circumstances with MHRA, and follow a parallel pathway to BLA with the FDA this year - Received FDA Rare Pediatric Disease Designations (RPDD) for four potential therapies for rare inherited retinal diseases (IRDs) including rAAV8.hRKp.AIPL1 for LCA4 - Received from HPRA and MHRA additional clinical and commercial licensures in Ireland and UK for Shannon and London GMP viral vector manufacturing facilities as well as QC facilities LONDON and NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced financial and operational results for the fourth quarter and full-year ended December 31, 2024, and provided a corporate update. “MeiraGTx demonstrated excellent execution in 2024, marked by significant advancements across each of our late stage clinical programs as well as our end-to-end manufacturing capabilities, achieving multiple positive clinical and regulatory milestones,” said Alexandria Forbes, Ph.D. |
globenewswire.com |
2025-03-13 10:00:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Enters into a Strategic Collaboration with Hologen AI to Expedite Phase 3 Development of AAV-GAD for Parkinson's Disease and Industrialize MeiraGTx's Proprietary Manufacturing Process |
- MeiraGTx to receive $200 million in upfront cash consideration - MeiraGTx and Hologen will form a joint venture, Hologen Neuro AI Ltd, with an additional $230 million committed capital from Hologen to fund 100% of the development of AAV-GAD for Parkinson's disease through to commercialization, as well as other potential pipeline products - MeiraGTx will enter into clinical and commercial supply agreements with Hologen Neuro AI Ltd to manufacture AAV-GAD and other locally delivered CNS genetic medicines - Hologen will also fund a portion of MeiraGTx's manufacturing operations and will own a minority stake in MeiraGTx's manufacturing subsidiary LONDON and NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced a broad strategic collaboration with Hologen Limited, a world-leading developer of multi-modal generative AI foundation models of real-world clinical data for clinical medicine and pharmaceutical drug development. MeiraGTx will receive $200 million in upfront cash at closing and MeiraGTx and Hologen are forming a joint venture, called Hologen Neuro AI Ltd. |
globenewswire.com |
2025-03-13 09:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Announces The Lancet Publication of Data Demonstrating the Efficacy of rAAV8.hRKp.AIPL1 for the Treatment of Leber Congenital Amaurosis 4 (LCA4) Retinal Dystrophy |
LONDON and NEW YORK, Feb. 21, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced the publication of results from the first-in-human interventional study to treat children with AIPL1-associated severe retinal dystrophy. The data were published in The Lancet in a paper titled, "Gene therapy in children with AIPL1-associated severe retinal dystrophy: an open-label, first-in-human interventional study". This paper presents data from the first 4 children treated unilaterally with rAAV8.hRKp.AIPL1. A further 7 children with LCA4 were treated bilaterally with rAAV8.hRKp.AIPL1 demonstrating similarly remarkable effects on vision, with all 11 of the 11 children treated who were blind at birth now having visual acuity in the treated eyes. |
globenewswire.com |
2025-02-21 08:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx: 2 Possible Near-Term BLA Filings Could Ignite Shareholder Value |
MeiraGTx Holdings plc is advancing AAV-AIPL1 for AIPL1-associated Leber congenital amaurosis 4, with a near-term BLA filing in the UK under Exceptional Circumstance possible. Bota-vec, developed with Janssen, could see a BLA filing for X-linked Retinitis Pigmentosa in 2025. Initiation of phase 3 study, using AAV-GAD for the treatment of patients with Parkinson's Disease, expected in 2025. |
seekingalpha.com |
2025-01-22 18:09:06 |
Czytaj oryginał (ang.) |
| MeiraGTx Receives Rare Pediatric Disease Designation from FDA for AAV8-RK-RetGC for the Treatment of Patients with Leber Congenital Amaurosis due to GUCY2D Mutations |
MeiraGTx has recently received Rare Pediatric Disease Designation (RPDD) for four inherited retinal diseases (IRDs) reflecting the transformative therapeutic potential of the Company's proprietary technology platforms MeiraGTx has recently received Rare Pediatric Disease Designation (RPDD) for four inherited retinal diseases (IRDs) reflecting the transformative therapeutic potential of the Company's proprietary technology platforms |
globenewswire.com |
2025-01-22 10:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Holdings: Behind The Recent Rally |
MeiraGTx Holdings plc has rallied over 40% following promising Parkinson's disease data, with significant potential in its Riboswitch platform for gene expression control. The company's diverse pipeline includes gene therapies for salivary gland conditions, neurological disorders, and inherited retinal diseases, with multiple BLAs expected from 2024-2027. Recent strategic deals with J&J and Sanofi have bolstered MeiraGTx's financial position, providing a runway into 2Q26 and highlighting strong investor confidence. |
seekingalpha.com |
2024-12-03 16:18:54 |
Czytaj oryginał (ang.) |
| MeiraGTx Holdings PLC (MGTX) Reports Q3 Loss, Tops Revenue Estimates |
MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $0.47. This compares to loss of $0.74 per share a year ago. |
zacks.com |
2024-11-13 12:15:34 |
Czytaj oryginał (ang.) |
| MGTX Stock Up on Upbeat Efficacy Data From Parkinson's Disease Study |
MeiraGTx stock rises 15% as gene therapy candidate betters sham treatment in Parkinson's disease patients. |
zacks.com |
2024-10-16 15:20:28 |
Czytaj oryginał (ang.) |
| MeiraGTx (MGTX) Surges 14.9%: Is This an Indication of Further Gains? |
MeiraGTx (MGTX) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term. |
zacks.com |
2024-10-16 11:46:09 |
Czytaj oryginał (ang.) |
| MeiraGTx: Positive PD Data Moves Needle Forward For Regulatory Meetings |
MeiraGTx Holdings plc's GAD gene therapy for Parkinson's Disease shows promising phase 1/2 results, with significant improvements in UPDRS Part 3 and PDQ-39 scores. The company plans to discuss phase 3 study designs with regulatory agencies in Q4 2024, potentially initiating late-stage studies in 2025. MeiraGTx secured $50 million in funding, including a $30 million equity investment from Sanofi, enhancing its financial stability for future developments. |
seekingalpha.com |
2024-10-15 17:32:06 |
Czytaj oryginał (ang.) |
| MeiraGTx Announces Poster Presentation on a Potential Treatment for MC4R Genetic Deficiency at the 2024 Society for Neuroscience Conference |
Results indicate a potent and effective locally delivered AAV-BDNF gene therapy for the treatment of obesity caused by MC4R deficiency Results indicate a potent and effective locally delivered AAV-BDNF gene therapy for the treatment of obesity caused by MC4R deficiency |
globenewswire.com |
2024-10-09 20:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Holdings PLC (MGTX) Reports Q2 Loss, Lags Revenue Estimates |
MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.76 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.53 per share a year ago. |
zacks.com |
2024-08-12 12:40:49 |
Czytaj oryginał (ang.) |
| MeiraGTx Announces $50 Million Offering of Ordinary Shares led by Sanofi and Reports Second Quarter 2024 Financial and Operational Results |
- Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented at the American Academy of Oral Medicine 2024 annual meeting (AAOM) showed meaningful improvements in patient-reported outcomes and saliva production with AAV2-hAQP1 treatment |
globenewswire.com |
2024-08-12 11:05:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Announces Pricing of Offering of Ordinary Shares Led by Sanofi |
LONDON and NEW YORK, Aug. 12, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicine company, today announced the pricing of an underwritten offering of 12,500,000 of its ordinary shares at an offering price of $4.00 per share. Gross proceeds to MeiraGTx from the offering are expected to be $50 million, before deducting underwriting discounts and commissions and offering expenses. All of the ordinary shares in the offering are being sold by MeiraGTx. |
globenewswire.com |
2024-08-12 11:03:00 |
Czytaj oryginał (ang.) |
| 5 Penny Stocks With 250% Upside in 1 Year According to Wall Street |
Penny stocks represent an interesting investment opportunity. |
247wallst.com |
2024-07-30 12:49:02 |
Czytaj oryginał (ang.) |
| MeiraGTx: A Very Attractive Longer-Term Play, With Potential Near-Term Catalysts |
Bota-vec sale to JNJ/Janssen is complete – cash & future milestones from the deal should carry MeiraGTx through the next catalysts. The partnership with Sanofi strengthens the balance sheet and helps validate technology platforms. MGTX is no longer just an ocular GTx (gene therapy) company - its GTx for radiation-induced xerostomia has a high potential for success. |
seekingalpha.com |
2024-07-15 15:02:26 |
Czytaj oryginał (ang.) |
| MeiraGTx Reports First Quarter 2024 Financial and Operational Results |
- Positive data from the Phase 1 AQUAx study in radiation-induced xerostomia (RIX) presented in an oral session at the American Academy of Oral Medicine 2024 annual meeting (AAOM) April 17-20, 2024 |
globenewswire.com |
2024-05-09 12:00:00 |
Czytaj oryginał (ang.) |
| MeiraGTx to Participate in Upcoming Investor Conferences |
LONDON and NEW YORK, April 24, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (NASDAQ: MGTX), a vertically integrated, clinical stage gene therapy company, today announced that Alexandria Forbes, Ph.D., President and Chief Executive Officer, will participate in the following investor conferences: |
globenewswire.com |
2024-04-24 20:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Announces Oral Presentation at the 2024 American Academy of Oral Medicine (AAOM) Annual Conference |
LONDON and NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage gene therapy company, today announced the Company gave an oral presentation at the American Academy of Oral Medicine Annual Conference, being held from April 16-20, 2024, at the Hyatt Regency Grand Cypress in Orlando, FL. |
globenewswire.com |
2024-04-18 20:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx Holdings PLC (MGTX) Reports Q4 Loss, Misses Revenue Estimates |
MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.47 per share versus the Zacks Consensus Estimate of a loss of $0.46. This compares to loss of $0.58 per share a year ago. |
zacks.com |
2024-03-14 12:46:12 |
Czytaj oryginał (ang.) |
| MeiraGTx Reports Fourth Quarter and Full Year 2023 Financial and Operational Results and Recent Business Updates |
- Company aligned with FDA on requirements for ongoing Phase 2 AQUAx2 clinical trial for Grade 2/3 radiation-induced xerostomia to be considered pivotal supporting potential BLA filing |
globenewswire.com |
2024-03-14 10:30:00 |
Czytaj oryginał (ang.) |
| MeiraGTx: Bota-Vec Program Advancing With Milestones Being Met |
Positive results achieved in phase 1/2 MGT009 study using bota-vec for the treatment of patients with XLRP; Patients given this gene therapy achieved meaningful improvement of vision. Enrollment completed in ongoing phase 3 LUMEOS study, using bota-vec for the treatment of patients with XLRP; Potential results could be released end of 2024 or in early 2025. The global Retinitis Pigmentosa market size is expected to reach $20.47 billion by 2029; It is said that 10% to 15% of RP patients have XLRP. |
seekingalpha.com |
2024-02-15 10:23:45 |
Czytaj oryginał (ang.) |
| Wall Street Analysts Think MeiraGTx Holdings PLC (MGTX) Could Surge 217.92%: Read This Before Placing a Bet |
The average of price targets set by Wall Street analysts indicates a potential upside of 217.9% in MeiraGTx Holdings PLC (MGTX). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock. |
zacks.com |
2024-01-10 13:19:15 |
Czytaj oryginał (ang.) |
| MeiraGTx (MGTX): Strong Industry, Solid Earnings Estimate Revisions |
MeiraGTx (MGTX) has seen solid earnings estimate revision activity over the past month, and belongs to a strong industry as well. |
zacks.com |
2024-01-10 12:32:52 |
Czytaj oryginał (ang.) |
| MeiraGTx (MGTX) Stock Surges 35% in a Month: Here's Why |
MeiraGTx's (MGTX) shares surge on the sale of rights for a rare ocular disease gene therapy for up to $ 415 million. This funding helps MGTX extend its cash runway into mid-2026. |
zacks.com |
2024-01-02 15:32:08 |
Czytaj oryginał (ang.) |