Karyopharm 提交 sNDA 申請 selinexor + ruxolitinib 用於骨髓纖維化

Karyopharm 已提交 sNDA 申請，尋求加速核准 selinexor 合併 ruxolitinib 用於骨髓纖維化。該公司已申請優先審查，並預計 FDA 將於 2026 年第 4 季發出受理通知及時程。轉為傳統核准將依據 Phase 3 SENTRY 試驗的長期整體存活數據。

關鍵事實

申報時間: 2026年8月31日下午12:08
事件: 申請已送件
方向: 中性
公司: KPTIKaryopharm
資產: selinexor
來源: SEC 8-K
可信度: 有出處

來源摘錄

8-K false 0001503802 0001503802 2026-08-31 2026-08-31 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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): August 31, 2026 Karyopharm Therapeutics Inc. (Exact Name of Registrant as Specified in Charter) Delaware 001-36167 26-3931704 (State or Other Jurisdiction of Incorporation) (Commission File Number) (IRS Employer Identification No.) 85 Wells Avenue , 2nd Floor Newton , Massachusetts 02459 (Address of Principal Executive Offices) (Zip Code) Registrant’s telephone number, including area code: (617) 658-0600 (Former Name or Former Address, if Changed Since Last Report) Check the appropriate box below if the Form

SEC 8-K