Earnings summaries and quarterly performance for MeiraGTx Holdings.
Executive leadership at MeiraGTx Holdings.
Board of directors at MeiraGTx Holdings.
Research analysts covering MeiraGTx Holdings.
Recent press releases and 8-K filings for MGTX.
MeiraGTx Reports Q3 2025 Results and Announces Strategic Collaborations
MGTX
Earnings
New Projects/Investments
Guidance Update
- MeiraGTx entered a strategic collaboration with Eli Lilly and Company in ophthalmology, receiving an upfront payment of $75 million and eligible for over $400 million in total milestone payments.
- The company reported cash and cash equivalents of $14.8 million as of September 30, 2025, and expects to have sufficient capital to fund operations into the second half of 2027 with anticipated funds from collaborations.
- MeiraGTx announced a strategic collaboration with Hologen AI, receiving $50 million of the $200 million upfront cash consideration due, with the remainder expected in Q4 2025, and Hologen committing up to $230 million into a joint venture for the AAV-GAD program.
- For the three months ended September 30, 2025, MeiraGTx reported service revenue of $0.4 million and a net loss of $50.5 million.
Nov 13, 2025, 1:08 PM
MeiraGTx Enters Strategic Collaboration with Eli Lilly and Company
MGTX
New Projects/Investments
- MeiraGTx Holdings plc announced a strategic collaboration in ophthalmology with Eli Lilly and Company, effective November 7, 2025.
- Under the agreement, MeiraGTx grants Lilly worldwide exclusive rights to its AAV-AIPL1 program for Leber congenital amaurosis 4 (LCA4) and access to its gene therapy technologies for ophthalmology.
- MeiraGTx will receive an upfront payment of $75 million and is eligible for over $400 million in total milestone payments, including up to $135 million in near-term cash consideration, plus tiered royalties on licensed products.
Nov 10, 2025, 12:07 PM
MeiraGTx announces strategic collaboration with Eli Lilly and Company for ophthalmology
MGTX
New Projects/Investments
- MeiraGTx Holdings plc has entered into a strategic collaboration with Eli Lilly and Company for the development and commercialization of genetic medicines in ophthalmology.
- MeiraGTx will grant Lilly worldwide exclusive rights to its AAV-AIPL1 program for Leber congenital amaurosis 4 (LCA4), which has shown unprecedented vision restoration in clinical trials.
- MeiraGTx is set to receive an upfront payment of $75 million and is eligible for over $400 million in total milestone payments, along with tiered royalties on licensed products.
- Lilly will also gain worldwide exclusive access to MeiraGTx's innovative gene therapy technologies for ophthalmology, including novel intravitreal capsids, bespoke promoters, and rights to its proprietary riboswitch technology for gene editing in the eye.
Nov 10, 2025, 12:00 PM
Genetic Medicines Companies Discuss Progress and Regulatory Landscape for Neurodegenerative Disease Therapies
MGTX
New Projects/Investments
Product Launch
- MGTX (MIRA) reported positive Phase 2 data for its Parkinson's gene therapy, demonstrating physiological brain changes and neuroprotective effects, and is leveraging AI technology to enhance its pivotal study design with FDA acceptance.
- UniCure announced compelling Phase 1/2 data for its Huntington's disease gene therapy, AMT-130, showing a 75% statistically significant slowing of disease progression over three years, and anticipates a pre-BLA meeting in Q4 2025 and BLA submission in Q1 2026.
- Passage Bio provided an update on its lead clinical program for Frontotemporal Dementia (FTD), which has shown high durable levels of target engagement and stabilized plasma neurofilaments, with further data expected next year.
- A key strategy across these companies for neurodegenerative gene therapies is local delivery and the use of lower doses to mitigate systemic safety risks and immune responses, a critical consideration given recent safety events in the sector.
- The panelists emphasized the FDA's increasing flexibility in regulatory pathways for rare neurodegenerative diseases, including openness to novel trial designs, biomarkers, and external controls, which could expedite product development and approval.
Oct 21, 2025, 7:30 PM
Genetic Medicines Companies Discuss Neurodegenerative Disease Programs and Regulatory Landscape
MGTX
New Projects/Investments
Product Launch
Guidance Update
- uniQure's AMT-130 for Huntington's disease demonstrated a 75% statistically significant slowing of disease progression based on composite UHDRS and total functional capacity in 45 patients with three years of follow-up data. The company expects a pre-BLA meeting in Q4 and BLA submission in Q1 next year.
- MeiraGTx Holdings' Parkinson's program has shown three positive studies and two positive studies UPDRS against SHAM, with AI analysis of FDG PET scans indicating physiological changes in the brain. The company is using AI to enhance the robustness of its primary endpoint in its pivotal study.
- Passage Bio's lead clinical program for frontotemporal dementia (FTD) with GRN mutation has demonstrated high durable levels of target engagement of CSF progranulin and stabilization of plasma neurofilaments, with more data expected next year.
- Panelists emphasized that local delivery of gene therapies and lower doses contribute to improved safety profiles by reducing systemic exposure and the risk of inflammatory responses, which is a key advantage for neurodegenerative diseases.
- Regulatory agencies, particularly the FDA, are showing increased flexibility for rare diseases with high unmet needs, including openness to single-arm studies with supportive evidence and the use of biomarkers to assess effectiveness, which is crucial for gene therapies in slow-progressing neurodegenerative conditions.
Oct 21, 2025, 7:30 PM
Quarterly earnings call transcripts for MeiraGTx Holdings.
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