Karyopharm completes enrollment in phase 3 myelofibrosis trial

Published 10/09/2025, 12:06
Karyopharm completes enrollment in phase 3 myelofibrosis trial

NEWTON, Mass. - Karyopharm Therapeutics Inc. (NASDAQ:KPTI) announced Wednesday it has completed enrollment in its Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib for JAKi-naïve myelofibrosis patients. According to InvestingPro data, the company, currently valued at $54.9 million, is operating with significant debt of $264.1 million while showing a concerning cash burn rate.

The trial enrolled 353 patients, with top-line results expected in March 2026. The study is designed to assess whether adding selinexor to ruxolitinib, the current standard of care, could potentially become the first approved combination therapy for myelofibrosis treatment. While the company’s stock has shown strong returns over the past three months, InvestingPro analysis indicates the company remains undervalued compared to its Fair Value, despite facing profitability challenges with an EBITDA of -$114.9 million in the last twelve months.

"We are excited to announce that we have completed enrollment of our Phase 3 SENTRY trial and look forward to sharing top-line data from this pivotal trial in March 2026," said Richard Paulson, President and Chief Executive Officer of Karyopharm, in a press release statement.

The SENTRY trial is randomizing patients 2-to-1 to receive either a once-weekly 60 mg dose of selinexor plus ruxolitinib or placebo plus ruxolitinib. The study’s co-primary endpoints are spleen volume response rate at week 24 and the average change in absolute total symptom score over 24 weeks relative to baseline.

Myelofibrosis is a rare blood cancer affecting approximately 20,000 patients in the United States and 17,000 in the European Union. The disease causes bone marrow scarring, making it difficult for the bone marrow to produce healthy blood cells, and leads to symptoms including enlarged spleen, progressive anemia, fatigue, and weakness.

Currently, JAK inhibitors are the only approved class of therapies for myelofibrosis. According to the company, more than 30% of patients discontinue the most commonly prescribed JAK inhibitor due to anemia.

Selinexor, marketed as XPOVIO, is already approved in the U.S. for certain indications in multiple myeloma and diffuse large B-cell lymphoma.

In other recent news, Karyopharm Therapeutics reported a decline in revenue for the second quarter of 2025. The total revenue fell to $37.9 million from $42.8 million in the same period the previous year. Despite the overall revenue drop, the company experienced a 6% year-over-year increase in net product revenue for XPOVIO, its flagship product. Karyopharm is also facing liquidity challenges, with a significant debt maturity approaching in October 2025. These developments highlight the company’s ongoing strategic shifts as it navigates financial pressures. Investors and analysts are closely watching Karyopharm’s financial maneuvers in response to these challenges.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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