MeiraGTx readies Europe-first filings for XLRP gene therapy bota-vec
The company says bota-vec paperwork is ready for the EMA in December, with a US filing planned a few months later, as a $75m Lilly upfront sits alongside.
MeiraGTx Holdings plc has finished assembling the European application for bota-vec (botaretigene sparoparvovec), its gene therapy for X-linked retinitis pigmentosa (XLRP), and intends to lodge it with the European Medicines Agency in December 2026. The company disclosed the timetable with its quarterly results on 12 November.
A US Biologics License Application is scheduled for the first quarter of 2027, so the EMA will receive the package first and the FDA a few months afterwards. Neither review has begun. Validation and assessment clocks only start once each submission is made, and the company gave no approval or launch dates.
On the deal side, MeiraGTx pointed to a licence agreement with Lilly covering AAV-AIPL1, which includes a $75 million upfront payment. The information available does not give any other financial terms, so the total value of the arrangement is unknown.
The update also covered the rest of the pipeline. The pivotal Phase 2 AQUAx2 trial of AAV-hAQP1 in radiation-induced xerostomia is still expected to report in mid-2027, and a Phase 3 study of AAV-GAD in Parkinson's disease is due to start in the first quarter of 2027.
Why it matters
- Bota-vec is set to move from development into regulatory review on both sides of the Atlantic within roughly four months, if MeiraGTx keeps to its schedule.
- The only disclosed deal figure is the $75 million Lilly upfront for AAV-AIPL1; wider economics and any milestone or royalty terms remain undisclosed.
- Mid-2027 AQUAx2 data and the planned Parkinson's Phase 3 start give a clear calendar of pipeline events beyond the XLRP filings.
Company's press release (SEC filing): MeiraGTx Holdings plc ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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