Karyopharm 提交 sNDA，申请 selinexor + ruxolitinib 用于骨髓纤维化

Karyopharm 提交了一份 sNDA，寻求 selinexor 联合 ruxolitinib 用于骨髓纤维化的加速批准。公司已申请优先审评，预计 FDA 将在 2026 年 Q4 发出受理通知及时间表。转为传统批准将依赖于 3 期 SENTRY 试验的长期总生存期数据。

关键事实

申报时间: 2026年8月31日 12:08
事件: 申请已提交
方向: 中性
公司: KPTIKaryopharm
资产: selinexor
来源: SEC 8-K
可信度: 有来源

来源摘录

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