MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV2-hAQP1 for the Treatment of Grade 2/3 Radiation-Induced Xerostomia
MeiraGTx Holdings plc - Ordinary Shares (MGTX)
Company Research
Source: GlobeNewswire
- RMAT designation recognizes the preliminary clinical evidence of the potential benefit of AAV2-hAQP1 as a one-time treatment for this debilitating condition - RMAT designation includes the benefits of the Fast Track and Breakthrough Therapy designations, allows frequent regulatory interactions with the FDA, and potential routes to accelerated approval and Priority Review LONDON and NEW YORK, Dec. 09, 2024 (GLOBE NEWSWIRE) -- MeiraGTx Holdings plc (Nasdaq: MGTX), a vertically integrated, clinical stage genetic medicines company, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to AAV2-hAQP1 for the treatment of Grade 2/3 radiation-induced xerostomia (RIX). “This RMAT designation underscores the strength of our data indicating the potential of our AAV2-hAQP1 therapy to significantly improve the lives of patients who suffer from xerostomia following radiation treatment. The requirements for rec
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MGTX
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- 11/13/24 - Miss
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- 11/13/24 - Form 10-Q
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