Ultragenyx Pharmaceutical Inc.
04/02/2026 | Press release | Distributed by Public on 04/02/2026 06:45
Material Event (Form 8-K)
Item 8.01 Other Events
On April 2, 2026, Ultragenyx Pharmaceutical Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") has accepted for review the Company's resubmitted Biologics License Application seeking accelerated approval for UX111 (rebisufligene etisparvovec) AAV9 gene therapy as a treatment for patients with Sanfilippo syndrome Type A (MPS IIIA). The FDA set a Prescription Drug User Fee Act (PDUFA) action date of September 19, 2026.
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