一次情報の記録
重要申請提出
Ultragenyx、UX111のBLAを再提出；PDUFAは2026年Q3に予定
UltragenyxはUX111の加速承認を求めてBLAを再提出した。FDAは6ヶ月以内に審査を完了し、PDUFA日は2026年Q3に設定される予定。再提出を裏付ける長期臨床データも開示された。
主要事実
出典の抜粋
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