{"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","discovered_at":"2026-08-31T12:10:01.049540+00:00","generated_at":"2026-08-31T12:10:07.615847+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Karyopharm submits sNDA for XPOVIO+ruxolitinib in myelofibrosis; seeks Priority Review","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-375495","json":"https://secwatch.observer/filing/0001193125-26-375495.json","markdown":"https://secwatch.observer/filing/0001193125-26-375495.md","text":"https://secwatch.observer/filing/0001193125-26-375495.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-31T12:10:07.615847+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}