MeiraGTx received FDA Breakthrough Therapy Designation for its gene therapy AAV2-hAQP1 targeting Grade 2 and 3 radiation-induced xerostomia, a severe dry mouth condition caused by cancer radiotherapy. Supported by three-year Phase 1 data, the therapy aims for a Biologics License Application (BLA) filing by mid-2027 and potential US launch in early 2028. The company also reported strategic collaborations with Eli Lilly and Hologen AI, advancing treatments for inherited eye diseases and Parkinson's, respectively, while progressing its riboswitch gene regulation platform. Financially, MeiraGTx ended 2025 with $65.9 million cash and expects funding through 2027, despite a net loss of $114.2 million for the year.
