Ultragenyx Pharmaceutical Inc 8-K, filed Sep 17, 2026
Ultragenyx Pharmaceutical Inc. (RARE)
About this 8-K
Ultragenyx Pharmaceutical Inc filed this 8-K on September 17, 2026.
Items reported
- Item 8.01: Other events
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
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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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Ultragenyx Pharmaceutical Inc. |
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Date: |
September 17, 2026 |
By: |
/s/ Howard Horn |
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Howard Horn |