Ultragenyx Pharmaceutical Inc.
DTX401
glycogen storage disease type Ia (GSDIa)
Countdown
48days
FDA decision · Aug 23, 2026
What's at stake
The FDA's approval decision on DTX401 for glycogen storage disease type Ia (GSDIa) is due Aug 23, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
Primary source
· SEC 8-K
verified 13h ago
“an anticipated Prescription Drug User Fee Act (PDUFA) action date in the third quarter of 2026.”