secwatch.observer — SEC 8-K summary
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Issuer:     Karyopharm Therapeutics Inc. (KPTI)
CIK:        0001503802
Form:       8-K
Filed at:   2026-07-31T12:30:33+00:00
Accession:  0001193125-26-326995
Event type: other_material
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Karyopharm: Phase 3 endometrial cancer trial misses primary endpoint; plans sNDA for myelofibrosis; exploring financing
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- Phase 3 XPORT-EC-042 trial of selinexor in TP53 wild-type endometrial cancer did not meet primary endpoint of PFS; median PFS 12.75 vs 7.43 months (HR=0.76, p=0.0791).
- Company plans to submit sNDA to FDA in August 2026 seeking accelerated approval of selinexor+ruxolitinib for myelofibrosis based on SVR35 at week 24.
- FDA requested further discussion on data to support sNDA and conversion to traditional approval; company will provide additional data before submission.
- Company, with Centerview Partners, is exploring financing transactions and strategic alternatives to extend cash runway; no assurance of any transaction.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1503802/000119312526326995/0001193125-26-326995-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1503802/000119312526326995/d71318d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-326995

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