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On August 31, 2026, Karyopharm Therapeutics Inc. announced the submission of a supplemental New Drug Application…
KPTIKaryopharm Therapeutics Inc.
On August 31, 2026, Karyopharm Therapeutics Inc. announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA). The application seeks Accelerated Approval for XPOVIO (selinexor) in combination with ruxolitinib for patients with myelofibrosis, based on data from the Phase 3 SENTRY trial. Karyopharm requested Priority Review to potentially achieve a six-month review timeline. The company expects FDA feedback on filing acceptance and review timelines during the fourth quarter of 2026 following the standard 60-day filing review period. If approved via the Accelerated Approval pathway, long-term overall survival data from the SENTRY trial will be required to verify clinical benefit and support conversion to traditional approval. Karyopharm Therapeutics Inc. operates in the biotechnology industry, developing and commercializing therapies for cancer.