Ultragenyx Pharmaceutical Inc.
02/23/2026 | Press release | Distributed by Public on 02/23/2026 07:46
Material Event (Form 8-K)
Item 8.01 Other Events.
On February 23, 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 Biologics License Application (the "BLA") seeking approval of DTX401 AAV gene therapy (pariglasgene brecaparvovec) for the treatment of Glycogen Storage Disease Type Ia (GSDIa). The FDA granted the BLA Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 23, 2026.
Ultragenyx Pharmaceutical Inc. published this content on February 23, 2026, and is solely responsible for the information contained herein. Distributed via EDGAR on February 23, 2026 at 13:46 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]