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Karyopharm Announces Preliminary Unaudited 2024 Revenue and 2025 Objectives

In This Article:

– Opportunity to Define a New Myelofibrosis Treatment Paradigm with Top-Line Data Readout from Phase 3 SENTRY Trial Evaluating Selinexor in Combination with Ruxolitinib in Patients with JAKi-Naïve Myelofibrosis Anticipated in 2H 2025; Company On Track to Complete Enrollment in 1H 2025 – 

– Recently Announced Key Leadership Changes, including the Appointment of Lori Macomber as Chief Financial Officer and Brendan Strong as SVP of Investor Relations and Corporate Communications – 

– Preliminary Unaudited Full Year 2024 Total Revenue and U.S. XPOVIO® (selinexor) Net Product Revenue Expected to be Approximately $145 Million and $113 Million, Respectively –

NEWTON, Mass., Jan. 13, 2025 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced preliminary unaudited fourth quarter and full year 2024 total revenue and U.S. XPOVIO net product revenue estimates and outlined its 2024 achievements and 2025 objectives.

"Our top strategic objective for 2025 is to deliver on the transformative opportunity to redefine the standard of care in myelofibrosis, with top-line results from our Phase 3 SENTRY trial on-track for the second half of this year.  Our teams are focused on high-quality clinical trial execution, engaging with investigators and diligently completing enrollment in the first half of this year," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are excited by the potential for selinexor to be the first all-oral combination therapy in myelofibrosis and the benefit it may bring to this community. We look forward to reporting our top-line data and are preparing for a rapid launch, leveraging our demonstrated commercialization capabilities."

Key Program Highlights in 2024

Selinexor in Multiple Myeloma (MM)

  • Demand for XPOVIO was consistent in 2024 versus 2023, with demand growth in the second half of 2024 in both the community setting, which represents approximately 60% of XPOVIO net product revenue, and the academic setting, offsetting a decline in demand in the first half of the year due to an intensified competitive landscape.

  • XPOVIO net product revenue was impacted year-over-year by higher gross-to-net adjustments in 2024, driven primarily by increased 340B discounts and Medicare rebates.

  • Expanded global patient access for selinexor in 2024 with favorable reimbursement decisions in the United Kingdom, France, Italy, China and South Korea and additional regulatory approvals in UAE, Kuwait, China, Malaysia, Turkey, Thailand, and South Korea in various indications, increasing the number of countries where selinexor is now approved to more than 45 countries.

  • Updated clinical data on selinexor in combination with pomalidomide and dexamethasone (SPd) regimen from the Phase 2 STOMP (NCT02343042) and the Phase 2 XPORT-MM-028 (NCT04414475) trials were published in the Frontiers of Oncology Journal in May 2024. Both trials are evaluating multiple selinexor combinations, including SPd, in patients with relapsed or refractory multiple myeloma. The updated results for SPd 40 mg from these studies showed a median progression free survival of 18.4 months and a manageable safety profile with no new safety signals identified.

  • Completed enrollment of the Phase 3 XPORT-MM-031 trial (EMN29; NCT05028348) of approximately 120 patients, leveraging the data published on selinexor 40 mg, pomalidomide and dexamethasone (SPd40) in 2024. The Phase 3 XPORT-MM-031 trial is being conducted in collaboration with the European Myeloma Network and is evaluating the all-oral combination SPd40 in patients with previously treated multiple myeloma who received an anti-CD38 in their immediate prior line of therapy.  Pending ongoing engagement with regulatory agencies on the updated protocol and statistical plan, the Company intends to provide an update on this trial.

  • Presented preclinical, translational, and real-world evidence data at multiple scientific conferences evaluating the role of XPO1 inhibition and selinexor in T-cell fitness.


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