MEIRAGTX HLDGSDL-,0000388

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.» Mehr auf seekingalpha.com

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.» Mehr auf benzinga.com

-  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.» Mehr auf globenewswire.com