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MeiraGTx Says Radiation-Induced Xerostomia Treatment Gets FDA Breakthrough Therapy Designation
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MeiraGTx Says Radiation-Induced Xerostomia Treatment Gets FDA Breakthrough Therapy Designation
Mar 26, 2026 6:16 AM

08:58 AM EDT, 03/26/2026 (MT Newswires) -- MeiraGTx ( MGTX ) said Thursday that the US Food and Drug Administration granted Breakthrough Therapy Designation to AAV2-hAQP1 for the treatment of Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract.

The company said it will present three-year data for the AAV2-hAQP1 program as well as an update on the commercial opportunity for this therapy on April 16.

Shares of the company were up 2.4% in Thursday premarket activity.

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