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Wednesday, August 19, 2026

Ultragenyx FDA accelerated approval for GENGLYCOS (DTX401) gene therapy in glycogen storage disease

 

Ultragenyx wins FDA accelerated approval for GENGLYCOS (DTX401) gene therapy in glycogen storage disease type Ia, marking its first gene therapy approval

  • Accelerated approval for GENGLYCOS (DTX401) earns Ultragenyx a U.S. FDA Priority Review Voucher.
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