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FDA Calendar - Ultragenyx Pharmaceutical Inc
Company Name
Ultragenyx Pharmaceutical Inc
RARE
Drug Name
DTX401 (BLA)
Event Name
FDA decision on DTX401 AAV gene therapy for the treatment of Glycogen Storage Disease Type Ia (GSDIa)
Event Date
08/23/2026
Outcome Date
Outcome
pending
Drug Status
Priority Review
Rival Drugs
If approved, DTX401 will be the first pharmacologic treatment to address the underlying cause of Glycogen Storage Disease Type Ia (GSDIa).
Market Potential
Other Approvals
News
Return to FDA Calendar
RELATED NEWS (Ultragenyx Pharmaceutical Inc)
Ultragenyx BLA For UX111 Gene Therapy Accepted By FDA
Ultragenyx Pharma: FDA Clears Investigational New Drug Application For UX016
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