Ultragenyx Pharmaceutical Inc.
09/17/2026 | Press release | Distributed by Public on 09/17/2026 13:56
Material Event (Form 8-K)
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Item 8.01 |
Other Events. |
On September 17, 2026, Ultragenyx Pharmaceutical Inc. ("Ultragenyx" or the "Company") announced that the U.S. Food and Drug Administration (the "FDA") granted standard full approval of FAYUVI™ (rebisufligene etisparvovec-hopf), also known as UX111, for the treatment of pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA, Sanfilippo syndrome Type A). FAYUVI is the first-ever FDA-approved treatment for Sanfilippo syndrome Type A, a progressive and fatal neurodegenerative disease, and the second gene therapy approval for Ultragenyx. The Company received a Priority Review Voucher upon this approval.
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