From GlobeNewswire: 2025-03-13 08:00:00

MeiraGTx Holdings plc announced a strategic collaboration with Hologen AI, involving a $200 million upfront payment and the formation of a joint venture, Hologen Neuro AI Ltd, to focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson’s disease. Positive data was shared from a clinical study of AAV-GAD for Parkinson’s disease, showing significant benefits. MeiraGTx also received FDA RMAT designation for AAV2-hAQP1 for radiation-induced xerostomia and published efficacy data for rAAV8.hRKp.AIPL1 in treating LCA4. The company received additional clinical and commercial licenses for its viral vector manufacturing facilities in Ireland and the UK. MeiraGTx also reported financial and operational results, highlighting progress made in 2024 and a commitment to drive innovation in genetic medicine. The company aims to continue addressing unmet needs in patients with rare and common diseases.

In 2024, MeiraGTx demonstrated significant advancements across its late-stage clinical programs and manufacturing capabilities. The company’s strategic collaboration with Hologen AI involves a $200 million upfront payment and the formation of a joint venture to focus on developing therapies targeting CNS circuitry. Positive data from a clinical study of AAV-GAD for Parkinson’s disease was announced, showing improvements in key efficacy endpoints. MeiraGTx also received FDA RMAT designation for AAV2-hAQP1 for radiation-induced xerostomia. Efficacy data for rAAV8.hRKp.AIPL1 in treating LCA4 was published, with plans to submit a Marketing Authorization Application for approval.

MeiraGTx received FDA Rare Pediatric Disease Designations for four potential therapies for rare inherited retinal diseases, including rAAV8.hRKp.AIPL1 for LCA4. The company also received additional clinical and commercial licensures in Ireland and the UK for its viral vector manufacturing facilities. MeiraGTx’s partnership with Hologen AI aims to advance the development of therapies targeting CNS circuitry, with a focus on AAV-GAD for Parkinson’s disease. Positive data from a clinical study of AAV-GAD demonstrated significant improvements in key efficacy endpoints.

MeiraGTx has made advancements in its late-stage clinical programs and manufacturing capabilities, with a strategic collaboration with Hologen AI and positive data from a clinical study of AAV-GAD for Parkinson’s disease. The company received FDA RMAT designation for AAV2-hAQP1 for radiation-induced xerostomia and published efficacy data for rAAV8.hRKp.AIPL1 in treating LCA4. MeiraGTx also received FDA Rare Pediatric Disease Designations for four therapies for rare inherited retinal diseases.

MeiraGTx announced a strategic collaboration with Hologen AI, including an upfront payment of $200 million and the formation of a joint venture to focus on expediting Phase 3 clinical development of AAV-GAD for Parkinson’s disease. Positive data from a clinical study of AAV-GAD showcased significant benefits for Parkinson’s disease patients. MeiraGTx also received FDA RMAT designation for AAV2-hAQP1 for radiation-induced xerostomia and published efficacy data for rAAV8.hRKp.AIPL1 in treating LCA4.

MeiraGTx’s collaboration with Hologen AI involves an upfront payment of $200 million and the formation of a joint venture, focusing on expediting Phase 3 clinical development of AAV-GAD for Parkinson’s disease. Positive data from a clinical study of AAV-GAD demonstrated significant benefits for Parkinson’s disease patients. The company also received FDA RMAT designation for AAV2-hAQP1 for radiation-induced xerostomia and published efficacy data for rAAV8.hRKp.AIPL1 in treating LCA4.



Read more at GlobeNewswire:: MeiraGTx Reports Fourth Quarter and Full Year 2024