原始来源记录
重大申请已提交
Ultragenyx 重新提交 UX111 BLA；PDUFA 预计 2026 年第三季度
Ultragenyx 已重新提交 UX111 的 BLA，寻求加速批准。FDA 预计将在六个月内完成审查，PDUFA 日期定于 2026 年第三季度。支持重新提交的长期临床数据也已披露。
关键事实
来源摘录
8-K 0001515673 false 0001515673 2026-02-03 2026-02-03 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 Date of Report (Date of earliest event reported): February 03, 2026 Ultragenyx Pharmaceutical Inc. (Exact name of Registrant as Specified in Its Charter) Delaware 001-36276 27-2546083 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 60 Leveroni Court Novato , California 94949 (Address of Principal Executive Offices) (Zip Code) Registrant’s Telephone Number, Including Area Code: 415 483-8800 (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form 8-K