NEWTON, Mass. — Karyopharm Therapeutics Inc. reported second-quarter 2026 revenue of $33.4 million and said it remains on track to submit a supplemental New Drug Application this month for selinexor in combination with ruxolitinib for patients with myelofibrosis.
The company plans to seek approval under the U.S. Food and Drug Administration’s Accelerated Approval pathway and intends to request Priority Review when it submits the application.
Karyopharm said the planned submission follows discussions with the FDA, including Type B and Type C meetings. The agency has provided written feedback indicating that spleen volume reduction of at least 35 percent, or SVR35, appears to qualify as a reasonably likely surrogate endpoint for predicting overall survival and could support the sNDA submission.
“Our planned submission under the Accelerated Approval pathway represents the beginning of an important new chapter for Karyopharm and an important milestone for the myelofibrosis community,” said Richard Paulson, President and Chief Executive Officer of Karyopharm. “If approved, selinexor plus ruxolitinib would become the first approved combination therapy for patients with myelofibrosis, introducing a novel therapeutic mechanism for the treatment of this disease within the multi-billion-dollar U.S. marketplace.”
The proposed application is supported by results from the Phase 3 SENTRY trial, which were presented at the 2026 American Society of Clinical Oncology Annual Meeting and published in the Journal of Clinical Oncology. Karyopharm said the study demonstrated rapid, deep and sustained spleen responses, promising overall survival findings and evidence consistent with potential disease modification.
Additional analyses presented at the European Hematology Association Congress provided further support for SVR35 as a potential predictor of overall survival, the company said.
Karyopharm is also continuing enrollment in the 40 mg cohort of its Phase 2 SENTRY-2 study after completing enrollment of 29 patients in the 60 mg cohort earlier this year. Topline data from the 60 mg cohort are expected in the second half of 2026.
For the second quarter ended June 30, Karyopharm reported total revenue of $33.4 million, down from $37.9 million a year earlier. U.S. XPOVIO net product revenue increased to $30.8 million from $29.7 million, while license and other revenue declined to $2.6 million from $8.2 million.
Royalty revenue from international partners, including Menarini and Antengene, rose to $2.5 million from $1.6 million a year earlier. Selinexor is approved in more than 50 countries and territories outside the United States.
The company reported a second-quarter net loss of $67 million, or $2.32 per basic and diluted share, compared with a net loss of $37.3 million, or $4.32 per share, in the year-ago period.
Research and development expenses declined to $29 million from $32.8 million, while selling, general and administrative expenses fell to $25.9 million from $28.5 million. Loss from operations narrowed to $22.5 million from $24.4 million.
Karyopharm reaffirmed its full-year 2026 revenue guidance of $130 million to $150 million, including U.S. XPOVIO net product revenue of $115 million to $130 million. The company expects R&D and SG&A expenses of $230 million to $245 million, excluding certain potential one-time costs.
The company said its existing liquidity and anticipated cash flow are expected to fund operations into September 2026. Karyopharm is evaluating financing opportunities and strategic alternatives with Centerview Partners and other advisers as it seeks to extend its cash runway.
A $15.8 million principal payment on Karyopharm’s senior secured term loan is due Sept. 10. The company said that if the payment is made without additional financing or a waiver from lenders, its liquidity would fall below a $10 million minimum covenant, resulting in an event of default.
Separately, Karyopharm said its Phase 3 XPORT-EC-042 study of selinexor as maintenance therapy in TP53 wild-type advanced or recurrent endometrial cancer did not meet its primary endpoint of progression-free survival. The company has since prioritized investment in its myelofibrosis and multiple myeloma programs.
Karyopharm also expects topline results from its Phase 3 XPORT-MM-031 trial in previously treated multiple myeloma in the second half of 2026.
