MeiraGTx Holdings plc (MGTX)

NEW YORK , Nov. 20, 2025 /PRNewswire/ -- Graviton Bioscience Corporation, a clinical-stage biotechnology company developing selective ROCK2 inhibitors for metabolic, inflammatory, fibrotic, and central nervous system disorders, among other therapeutic indications, today announced that Samuel Waksal, Ph.D., Chief Executive Officer, will participate in a fireside chat at the 8th Annual Evercore HealthCONx Conference.

MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.62 per share versus the Zacks Consensus Estimate of a loss of $0.5. This compares to a loss of $0.54 per share a year ago.

LONDON and NEW YORK, Nov. 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 third quarter ended September 30, 2025, and provided a corporate update.

MeiraGTx Holdings plc secures a transformative partnership with Eli Lilly, granting worldwide rights to its AAV-AIPL1 gene therapy for LCA4. MGTX receives $75 million upfront, up to $400 million in milestones, and tiered royalties, strengthening its financial position and reducing near-term dilution risk. The company's riboswitch technology and multiple collaborations, including with Johnson & Johnson and Hologen, highlight its innovation and diversified pipeline.

MeiraGTx Holdings has signed a deal with Eli Lilly , potentially worth over $475 million, granting the pharma giant rights to its experimental gene therapy for a rare, inherited disorder that causes severe vision loss from birth.

LONDON and NEW YORK, Nov. 10, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced a broad strategic collaboration in the area of ophthalmology with Eli Lilly and Company (“Lilly”).

MeiraGTx (MGTX) possesses the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

MeiraGTx (MGTX) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock doesn't suggest further strength down the road.

LONDON and NEW YORK, Oct. 07, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced the Company will exhibit two posters at the European Society of Gene and Cell Therapy (ESGCT) 2025 Annual Congress, which is being held from October 7-10, 2025, in Seville, Spain. The posters are available on the Posters and Publications page of the Company's website.

MeiraGTx is a clinical-stage gene therapy biotech with end-to-end GMP. Its late-stage assets include AAV-AIPL1, AAV-AQP1, and Bota-Vec. AAV-AQP1 is in pivotal Phase 2 trials under the FDA's RMAT designation for radiation-induced xerostomia. MGTX anticipates its BLA by 2026. I believe their Hologen partnership for PD is MGTX's main value driver. This should fund AAV-GAD through Phase 3 and commercialization if successful.

MeiraGTx Holdings PLC (MGTX) came out with a quarterly loss of $0.48 per share versus the Zacks Consensus Estimate of a loss of $0.52. This compares to a loss of $0.76 per share a year ago.

-  Gained alignment with U.S. Food and Drug Administration (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 Biologics License Application (BLA) filing; on track for potential data readout late 2026 -  FDA Granted Regenerative Medicine Advanced Therapy (RMAT) designation for AAV-GAD for the treatment of Parkinson's disease -  In collaboration with Hologen, FDG-PET data from positive Phase 2 double-blind, sham-surgery controlled clinical trials of AAV-GAD shows significant disease-modifying effects in pathological basal ganglia circuitry, including the substantia nigra – the site of dopamine-producing neurons affected in Parkinson's disease -  On track to file for Marketing Authorization Approval (MAA) under exceptional circumstances with the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of LCA4, and BLA in the US with the FDA via a similar pathway to approval in the fourth quarter of 2025 LONDON and NEW YORK, Aug. 14, 2025 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical-stage genetic medicines company, today announced financial and operational results for the second quarter ended June 30, 2025, and provided a corporate update. “During the second quarter, we continued to have very productive regulatory interactions with the MHRA and FDA around multiple later stage clinical programs as well as manufacturing,” said Alexandria Forbes, Ph.D.

Investors interested in the Genomics and Synthetic Biology theme should keep an eye on MGTX, BEAM and KRYS.

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

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.

-  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.