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High materiality8/10

Karyopharm on track for August selinexor myelofibrosis sNDA submission

Aug 13, 2026, 7:35 AM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Near-term sNDA submission and Priority Review potential can act as a positive catalyst, especially if FDA feedback remains favorable; SENTRY data reinforce clinical potential, supporting multiple upcoming readouts and regulatory milestones in 2H26.

AI summary

What happened, with direct paths to the underlying reporting

Karyopharm reported Q2 2026 results and confirmed an August sNDA filing for selinexor with ruxolitinib in myelofibrosis, seeking Priority Review. SENTRY data bolster the potential of the combo as a first approved myelofibrosis therapy, though the company faces a tight cash runway and debt due in September, implying near-term regulatory catalysts but financing risks.

  • Q2 2026 total revenue $33.4M; U.S. XPOVIO net product revenue $30.8M.
  • August sNDA submission for selinexor plus ruxolitinib in myelofibrosis on track; Priority Review planned.
  • SENTRY data presented at ASCO/EHA supports SVR35 as a predictor of overall survival.
  • 2026 guidance: total revenue $130–$150M; U.S. XPOVIO revenue $115–$130M; costs trimmed.
  • Cash runway to September 2026; $15.8M debt due Sept 10; covenant risk.

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