As of Oct 26, 2026: Ultragenyx Pharmaceutical (RARE) announced the FDA's approval of UX111 on Sep 17, 2026; its PDUFA date was Sep 19, 2026. Its Quality Score is -2. Scores as of 8:31 PM ET, 15 minutes behind.

RARE FDA decision on UX111

Ultragenyx Pharmaceutical · PDUFA date

OutcomeApprovedannounced Sep 17 Quality Score-2Poor

Cash runway3quarters of cash

The FDA's decision

Approved. Ultragenyx Pharmaceutical announced the FDA's approval of UX111 on Sep 17, 2026.

“In April 2026, the FDA accepted for review the resubmitted BLA seeking accelerated approval for UX111 as a treatment for MPS IIIA and assigned a PDUFA action date of September 19, 2026.”

PDUFA date, Sep 19, 2026. As Ultragenyx Pharmaceutical stated in its 8-K of Aug 4, 2026 (the filing).

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