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MeiraGTx Announces FDA Breakthrough Therapy Designation for AAV2-hAQP1 for the Treatment of Grade 2 and Grade 3 Radiation-Induced Xerostomia (RIX) and Reports Fourth Quarter and Full Year 2025 Financial and Operational Results

MeiraGTx (MGTX)MeiraGTxFDA / regulatory

FDA granted Breakthrough Therapy Designation for AAV2-hAQP1 for the treatment of Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract MeiraGTx to hold a program update and present long-term data for AAV2-hAQP1 program for the treatment of Grade 2/3

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MeiraGTx

Genetic Medicines Company MeiraGTx develops and manufactures gene therapies for inherited retinal disease, salivary-gland disorders, and other conditions. Its vertically integrated model spans vector design, clinical development, and commercial manufacturing. Bota-Vec Botaretigene sparoparvovec is an AAV gene therapy for X-linked...

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