Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company focused on cancer therapies, plans to submit a supplemental New Drug Application to the U.S. Food and Drug Administration in August 2026 for selinexor in combination with ruxolitinib as a treatment for myelofibrosis.
The company said it will seek accelerated approval following discussions with the FDA. According to Karyopharm’s announcement, the agency provided written feedback that a spleen volume reduction of at least 35%—known as SVR35—appears capable of serving as a surrogate endpoint reasonably likely to predict overall survival. Karyopharm also plans to request Priority Review when it submits the application.
The proposed application will rely on data from SENTRY, a randomized, double-blind Phase 3 trial involving 353 patients with myelofibrosis who had not previously received a JAK inhibitor. The trial compared once-weekly selinexor plus ruxolitinib with placebo plus ruxolitinib.
At week 24, 49.8% of patients receiving the selinexor combination achieved SVR35, compared with 28.0% of patients receiving ruxolitinib alone. However, SENTRY did not meet its second co-primary endpoint. Improvement in absolute total symptom score was similar between the two groups and was not statistically significant.
“We are grateful to the FDA for its thoughtful and collaborative engagement,” Karyopharm Chief Executive Officer Richard Paulson said.
Karyopharm said preliminary trial results also showed an overall-survival signal, but the data remain immature. The ongoing blinded follow-up will be used to collect longer-term overall-survival data, a prespecified secondary endpoint, to verify clinical benefit if the combination receives accelerated approval.
The company reported $90.9 million in cash and cash equivalents as of March 31, 2026, along with a $1.8 billion accumulated deficit. In its first-quarter filing, Karyopharm said there was substantial doubt about its ability to continue as a going concern within one year and that its operations depend on securing additional funding or pursuing strategic alternatives.
Upcoming Catalysts
Karyopharm plans to submit the sNDA and request Priority Review in August 2026. If the FDA accepts the application and grants Priority Review, the company said the target action date would be approximately six months after the agency receives the filing. Continued overall-survival follow-up from SENTRY will also be used to assess and potentially verify the treatment’s clinical benefit.
Sources
- Karyopharm Plans to Submit sNDA for Selinexor Plus Ruxolitinib in Myelofibrosis Under Accelerated Approval Pathway — July 30, 2026, via PR Newswire
- Karyopharm Reports Phase 3 SENTRY Topline Results — March 24, 2026, via Karyopharm Investor Relations
- Karyopharm Quarterly Report for the Period Ended March 31, 2026 — filed May 14, 2026, via SEC EDGAR
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This article is based entirely on publicly available information, including press releases, SEC filings, and publicly available news sources. Securities discussed or referenced include Karyopharm Therapeutics Inc. (Nasdaq: KPTI). Next Gen Tech Stocks has not received any compensation from any company mentioned, its management, investor relations representatives, or any third party for this specific article. Next Gen Tech Stocks may have current or past paid business relationships with other companies, which does not influence the content or conclusions of this article. No staff member or principal of Next Gen Tech Stocks holds a position in any security mentioned at the time of publication.
Sources include Karyopharm’s July 30, 2026, press release distributed through PR Newswire; the company’s March 24, 2026, SENTRY trial results; and its quarterly report for the period ended March 31, 2026, filed with the SEC on May 14, 2026.
The selinexor-ruxolitinib combination has not been approved by the FDA for myelofibrosis. The planned sNDA has not yet been submitted, and FDA acceptance, Priority Review designation, accelerated approval, and final approval are not guaranteed. The SENTRY trial met its SVR35 co-primary endpoint but did not meet its Abs-TSS co-primary endpoint. Overall-survival findings remain preliminary and require continued follow-up.
As of March 31, 2026, Karyopharm reported $90.9 million in cash and cash equivalents, an accumulated deficit of $1.8 billion, and substantial doubt regarding its ability to continue as a going concern within one year. The company stated that its continued operations depend on additional funding or strategic alternatives. Financial figures are based on the company’s disclosures as of March 31, 2026, and readers should verify current information.
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