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FDA approval timeline FDA designations: Breakthrough Therapy, Fast Track, Orphan Drug, Priority Review Financial forecast (reported in millions) pariglasgene brecaparvovec (DTX401) IV Manufacturer: Ultragenyx Proposed indications Glycogen storage disease type Ia (GSDIa) Clinical overview Mechanism of action DTX401 is an adeno-associated virus vector type 8 (AAV8) gene therapy designed to deliver stable expression and activity of glucose-6-phosphatase (G6Pase)