Key insights
- MeiraGTx received FDA Breakthrough Therapy Designation for its xerostomia treatment, AAV2-hAQP1. Phase 2 data is expected, with a potential BLA filing in early 2027 and US launch in 2028. Revenue increased due to the Eli Lilly collaboration, and the company anticipates funding operations into the second half of 2027. This news signals positive momentum for the company, but its limited impact on the broader US equity market warrants a low influence score.
MeiraGTx Holdings plc (MGTX) announced that the FDA granted Breakthrough Therapy Designation for its AAV2-hAQP1 treatment for Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract.
The designation was supported by 3-year data from a Phase 1 dose escalation study. MeiraGTx plans to present this long-term data and provide a program update on April 16, 2026.
The company is currently enrolling final patients in its Phase 2 AQUAx2 study, with data expected 12 months after the last patient is treated. MeiraGTx anticipates filing a Biologics License Application in the first half of 2027, with potential approval around the end of 2027 and US launch targeted for early 2028.
For the year ended December 31, 2025, MeiraGTx reported total revenue of $81.4 million, compared to $33.3 million in 2024. The increase was primarily due to $75.0 million in license revenue from its collaboration agreement with Eli Lilly and Company for the AAV-AIPL1 program.
Net loss for 2025 was $114.2 million, or $1.42 per share, compared to a net loss of $147.8 million, or $2.12 per share, in 2024.
The company had cash and cash equivalents of $65.9 million as of December 31, 2025, down from $103.7 million at the end of 2024. Including additional funding received and expected from strategic collaborations, MeiraGTx believes it has sufficient capital to fund operations into the second half of 2027.
Research and development expenses increased to $129.6 million in 2025 from $119.5 million in 2024, primarily due to higher manufacturing costs and clinical program activities.