As of Oct 26, 2026: Ultragenyx Pharmaceutical (RARE) announced the FDA's approval of DTX401 on Aug 19, 2026; its PDUFA date was Aug 23, 2026. Its Quality Score is -2. Scores as of 9:21 PM ET, 15 minutes behind.

RARE FDA decision on DTX401

Ultragenyx Pharmaceutical · PDUFA date

OutcomeApprovedannounced Aug 19 Quality Score-2Poor

Cash runway3quarters of cash

The FDA's decision

Approved. Ultragenyx Pharmaceutical announced the FDA's approval of DTX401 on Aug 19, 2026.

“for review the Biologics License Application (BLA) seeking approval of DTX401 as a treatment for GSDIa and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 23, 2026.”

PDUFA date, Aug 23, 2026. As Ultragenyx Pharmaceutical stated in its 8-K of Aug 4, 2026 (the filing).

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