secwatch.observer — SEC 8-K summary
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Issuer:     Karyopharm Therapeutics Inc. (KPTI)
CIK:        0001503802
Form:       8-K
Filed at:   2024-10-31T23:59:59+00:00
Accession:  0001193125-24-248162
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Karyopharm changes co-primary endpoint for Phase 3 SENTRY trial to Abs-TSS; increases sample size to 350
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- Co-primary endpoint changed from TSS50 to Abs-TSS following FDA alignment; SVR35 remains co-primary.
- Phase 1 Selinexor+ruxolitinib data showed 79% SVR35 (n=14) and 18.5-point average Abs-TSS improvement (n=9) at week 24.
- Total sample size increased to ~350 patients to improve statistical power; top-line data still expected in 2H 2025.
- Safety profile remains consistent with no new signals; change supported by key investigators and MPN Research Foundation.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1503802/000119312524248162/0001193125-24-248162-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1503802/000119312524248162/d891084d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-248162

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer