Nag-sumite ang Karyopharm ng sNDA para sa selinexor + ruxolitinib sa myelofibrosis

Nag-sumite ang Karyopharm ng sNDA na humihiling ng Accelerated Approval para sa selinexor kasama ang ruxolitinib sa myelofibrosis. Hiniling ng kumpanya ang Priority Review at inaasahan ang abiso at mga timeline ng FDA filing-acceptance sa Q4 2026. Ang conversion sa tradisyonal na approval ay nakasalalay sa pangmatagalang overall-survival data mula sa Phase 3 SENTRY trial.

Mahahalagang fact

Na-file: Ago 31, 2026, 12:08 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Neutral
Kumpanya: KPTIKaryopharm
Asset: selinexor
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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