---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-375495"
form_type: "8-K"
ticker: "KPTI"
cik: "0001503802"
company_name: "Karyopharm Therapeutics Inc."
filed_at: "2026-08-31T12:08:49+00:00"
generated_at: "2026-08-31T12:10:07.615847+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Karyopharm submits sNDA for XPOVIO+ruxolitinib in myelofibrosis; seeks Priority Review

## Summary
- On Aug 31, 2026, submitted sNDA to FDA for XPOVIO (selinexor) plus ruxolitinib in myelofibrosis, requesting Priority Review.
- FDA decision on filing acceptance and review timelines expected in Q4 2026 after 60-day filing review period.
- Submission based on Phase 3 SENTRY trial data, including promising overall survival signal and positive benefit-risk profile.
- Accelerated Approval would require FDA to accept SVR35 (spleen volume reduction ≥35%) as surrogate endpoint for overall survival.
- Company plans to use long-term SENTRY overall survival data to verify clinical benefit and convert to traditional approval.

## SEC filing metadata
- accession: 0001193125-26-375495
- form_type: 8-K
- ticker: KPTI
- cik: 0001503802
- company_name: Karyopharm Therapeutics Inc.
- filed_at: 2026-08-31T12:08:49+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1503802/000119312526375495/0001193125-26-375495-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1503802/000119312526375495/d423030d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-375495
- JSON: https://secwatch.observer/filing/0001193125-26-375495.json
- Plain text: https://secwatch.observer/filing/0001193125-26-375495.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.