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MeiraGTx Presents Bota-Vec Filing Plans Targeting Potential US, EU Approvals in 2027

PUBT·11/13/2026 15:38:05
MeiraGTx Presents Bota-Vec Filing Plans Targeting Potential US, EU Approvals in 2027
  • MeiraGTx plans bota-vec's European marketing application in December 2026, with a complete US biologics license application expected in Q1 2027.
  • Potential US and European approvals for the X-linked retinitis pigmentosa therapy are targeted for 2027.
  • The Phase 3 trial missed statistical significance on its primary endpoint but showed significant improvements across secondary measures of vision.
  • AAV-AQP1 completed pivotal Phase 2 enrollment for radiation-induced xerostomia, with a potential biologics license application filing in mid-2027.
  • Parkinson's therapy AAV-GAD is Phase 3-ready, with a potential biologics license application filing in 2028.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. MeiraGTx Holdings plc published the original content used to generate this news brief on November 13, 2026, and is solely responsible for the information contained therein.