Karyopharm: Phase 3 endometrial cancer trial misses primary endpoint; plans sNDA for myelofibrosis; exploring financing

Karyopharm Therapeutics Inc.

Phase 3 XPORT-EC-042 trial of selinexor in TP53 wild-type endometrial cancer did not meet primary endpoint of PFS; median PFS 12.75 vs 7.43 months (HR=0.76, p=0.0791).
Company plans to submit sNDA to FDA in August 2026 seeking accelerated approval of selinexor+ruxolitinib for myelofibrosis based on SVR35 at week 24.
FDA requested further discussion on data to support sNDA and conversion to traditional approval; company will provide additional data before submission.
Company, with Centerview Partners, is exploring financing transactions and strategic alternatives to extend cash runway; no assurance of any transaction.

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