Karyopharm says myelofibrosis sNDA submission remains on track for August

Karyopharm Therapeutics said its planned supplemental New Drug Application for selinexor combined with ruxolitinib in myelofibrosis remains on track for submission in August under the FDA's Accelerated Approval pathway, following continued engagement with the agency.¹ Karyopharm intends to request Priority Review at the time of submission.¹ The filing is supported by written FDA feedback that spleen volume reduction of at least 35% appears to qualify as a reasonably likely surrogate endpoint to predict overall survival and can support an sNDA submission.¹

In other pipeline updates, the company continued enrolling patients into the 40 mg cohort of the Phase 2 SENTRY-2 trial, following completion of enrollment of the 60 mg cohort (n=29) earlier this year,¹ with topline data from the 60 mg cohort expected in the second half of 2026.¹ In endometrial cancer, the Phase 3 XPORT-EC-042 trial did not meet its primary endpoint of progression-free survival, though a trend favoring selinexor was seen in the modified intent-to-treat population, with median PFS of 12.75 months versus 7.43 months for placebo (hazard ratio 0.76, one-sided p=0.0791).¹ Following those results, the company said it has prioritized future investment toward its myelofibrosis and multiple myeloma programs.¹ The Phase 3 XPORT-MM-031 multiple myeloma trial continues, with topline data expected in the second half of 2026.¹

On finances, cash, cash equivalents, restricted cash and investments totaled $65.4 million as of June 30, 2026.¹ The company said its existing liquidity, together with anticipated revenue, is expected to fund current operating plans into September 2026.¹ A $15.8 million principal payment is due September 10, 2026 under its senior secured term loan, and if made without additional financing or a lender waiver, cash could fall below the $10.0 million minimum liquidity covenant, triggering a loan default.¹ Karyopharm, working with financial advisor Centerview Partners, said it is evaluating financing and strategic alternatives.¹