-- Top-Line Data from the Phase 3 SENTRY Trial in Myelofibrosis on Track for March 2026 --
-- Top-Line Data from the Phase 3 XPORT-EC-042 Trial in Endometrial Cancer on Track for Mid-2026 --
-- Preliminary Unaudited Full Year 2025 Total Revenue and U.S. XPOVIO$(R)$ (selinexor) Net Product Revenue Expected to be Approximately $145 Million and $115 Million, Respectively --
NEWTON, Mass., Jan. 12, 2026 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced preliminary unaudited fourth quarter and full year 2025 total revenue and U.S. XPOVIO net product revenue estimates and outlined its 2025 achievements and 2026 objectives.
"2026 has the promise to be a transformative year for Karyopharm and the patient communities that we intend to serve, with top-line data from our Phase 3 SENTRY trial in myelofibrosis expected in March. Positive data from our SENTRY trial could unlock our opportunity to improve patient outcomes and redefine the standard-of-care in myelofibrosis. Our teams are actively preparing for regulatory filings, commercialization and the opportunity to rapidly launch with the first ever combination therapy in a multi-billion dollar market," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "In endometrial cancer, we remain focused and on track to report top-line data from our Phase 3 XPORT-EC-042 trial in mid-2026, representing a significant opportunity to transform patient outcomes in a targeted, biomarker driven patient population. With two high-potential data readouts this year, 2026 is expected to be a catalyst-rich year that could position us for tremendous long-term value creation."
Key Program Highlights in 2025
Selinexor in Multiple Myeloma
-- Demand for XPOVIO was consistent in 2025 versus 2024 in the increasingly
competitive multiple myeloma marketplace, with the community setting
continuing to drive approximately 60% of overall net product revenue.
-- Global patient access for selinexor expanded in 2025, with favorable
reimbursement decisions in Spain and China, and additional regulatory
approvals in multiple countries where selinexor is now approved in more
than 50 countries.
Selinexor in Myelofibrosis
-- Completed enrollment of the Phase 3 SENTRY trial
(XPORT-MF-034; NCT04562389) with 353 patients in early September 2025.
SENTRY is evaluating 60 mg once-weekly selinexor in combination with
ruxolitinib compared to ruxolitinib plus placebo. The preliminary
baseline characteristics for patients enrolled in SENTRY as presented at
the American Society of Hematology 2025 Annual Meeting (n=320) are
representative of the intended patient population. In addition,
preliminary blinded aggregate safety data from the first 61 patients with
a median follow-up of greater than 12 months may suggest improvements in
both hematologic and non-hematologic treatment emergent adverse events as
compared to the Phase 1 data evaluating selinexor 60 mg weekly in
combination with standard of care ruxolitinib in JAKi-naïve
myelofibrosis patients, as well as historical ruxolitinib monotherapy
data. The Company cautions that preliminary baseline characteristics and
preliminary blinded aggregate safety data from the Phase 3 SENTRY trial
may not ultimately be reflective of the actual trial results.
-- Presented data from the XPORT-MF-035 (NCT04562870) Phase 2, randomized,
open-label trial of selinexor versus physician's-choice in hard-to-treat
patients with heavily pretreated myelofibrosis (n=24) at the European
Hematology Association 2025 Congress. The data suggest the potential for
single-agent clinical activity with selinexor, including spleen volume
reduction, symptom improvement, hemoglobin stabilization, reduced
transfusion burden, and evidence of disease modification.
Selinexor in Endometrial Cancer
-- Modified the design of the Phase 3 XPORT-EC-042 (NCT05611931) trial to:
a) focus enrollment on patients with either: i) proficient mismatch
repair status (pMMR) tumors; or ii) patients with deficient mismatch
repair status (dMMR) tumors who are medically ineligible for checkpoint
inhibitors; b) introduce a new modified intent-to-treat $(ITT)$ population
of approximately 220 patients comprised of this focused population; and,
c) increase the ITT sample size to approximately 276 patients.
-- Enrollment continues in the Phase 3 XPORT-EC-042 trial evaluating
selinexor as a maintenance-only therapy following systemic therapy versus
placebo in patients with TP53 wild-type advanced or recurrent endometrial
cancer.
Corporate and Financial Highlights for 2025
-- Based on preliminary unaudited financial information, the Company expects
total revenue, which includes license and royalty revenue from partners,
to be approximately $33 million for the fourth quarter 2025 and
approximately $145 million for the full year 2025, and U.S. XPOVIO net
product revenue to be approximately $32 million for the fourth quarter
2025 and approximately $115 million for the full year 2025.
-- Completed strategic financing transactions that extended cash runway
beyond the expected top-line readout of the Phase 3 SENTRY trial in
myelofibrosis.
-- Cash, cash equivalents, restricted cash and investments as of December
31, 2025 were approximately $64 million. The Company expects its
existing liquidity, including the revenue it expects to generate from
XPOVIO net product sales and its license agreements, will be sufficient
to fund its planned operations into the second quarter of 2026.
The financial information presented in this press release may be adjusted as a result of the completion of customary annual review and audit procedures.
Anticipated Catalysts and Operational Objectives in 2026
Myelofibrosis
-- Top-line data from the Phase 3 SENTRY trial is expected in March 2026.
-- The Company expects to report top-line data from all patients in the 60
mg cohort of the Phase 2 SENTRY-2 trial with at least 24 weeks of
follow-up in the second half of 2026.
Endometrial Cancer
-- Top-line data from the event-driven, Phase 3 XPORT-EC-042 trial is
expected in mid-2026. The Company continues to enroll patients into the
XPORT-EC-042 trial of selinexor as a maintenance monotherapy for patients
with TP53 wild-type advanced or recurrent endometrial cancer.
Multiple Myeloma
-- Maintain the Company's commercial foundation in the increasingly
competitive multiple myeloma marketplace and drive increased XPOVIO
revenues.
-- Continue to support global launches by our partners following regulatory
and reimbursement approvals for selinexor in ex-U.S. territories.
-- Continue to follow patients that are enrolled in the Phase 3 XPORT-MM-031
(EMN29) trial. The Company expects to report top-line data from this
event-driven trial in the second half of 2026.
Corporate Presentation
Karyopharm will be posting an updated corporate overview presentation on its website today. The presentation will be accessible under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations.
About the Phase 3 SENTRY Trial
SENTRY (XPORT-MF-034; NCT04562389) is a Phase 3 clinical trial evaluating a once-weekly dose of 60 mg of selinexor in combination with ruxolitinib compared to placebo plus ruxolitinib in JAKi-naïve myelofibrosis patients with platelet counts >100 x 10(9) /L. Patients are randomized 2-to-1 to the selinexor arm. The co-primary endpoints for this trial are spleen volume reduction >= 35% (SVR35) at week 24 and the average change in absolute total symptom score (Abs-TSS) over 24 weeks relative to baseline.
About Myelofibrosis
Myelofibrosis is a rare blood cancer that affects approximately 20,000 patients in the United States and 17,000 patients in the European Union(1) . The disease causes bone marrow fibrosis (scarring in the bone marrow), which makes it difficult for the bone marrow to make healthy blood cells, splenomegaly (enlarged spleen), progressive anemia which often leads to symptoms like fatigue and weakness, and other disease associated symptoms including abdominal discomfort, pain under the left ribs, early satiety, night sweats and bone pain. The only approved class of therapies to treat myelofibrosis are JAK inhibitors, including ruxolitinib. Patients treated with the most commonly prescribed JAK inhibitor often require blood transfusions, and more than 30% will discontinue treatment due to anemia.(2) Anemia and transfusion dependence are correlated with poor prognosis and shortened survival.(3)
(1.) Clarivate/DRG (2023)
(2.) Palandri, F., Palumbo, G.A., Elli, E.M. et al. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis. Blood Cancer J. 11, 4 (2021).
(3.) Pardanani, A., & Tefferi, A. (2011). Prognostic relevance of anemia and transfusion dependency in myelodysplastic syndromes and primary myelofibrosis. Haematologica, 96(1), 8--10.
About the Phase 3 XPORT-EC-042 Trial
(MORE TO FOLLOW) Dow Jones Newswires
January 12, 2026 07:00 ET (12:00 GMT)
Comments