Phase 3 Endometrial Cancer Trial Fails, Karyopharm Pivots to Myelofibrosis
KPTI is trading near its 52-week low of $3.65 (38% below the low) on elevated volume (6.5× avg).
Summary
Karyopharm's Phase 3 trial of selinexor as maintenance therapy in endometrial cancer missed its primary endpoint of progression-free survival. The company is slashing investment in the program and redirecting resources to myelofibrosis and multiple myeloma. Shares crashed to $2.49 after hours, below the prior record low of $3.51, wiping out a 2.1% regular-session gain. This follows a going-concern warning and a cash runway only into late Q3 2026, making the pipeline setback acutely threatening. An sNDA submission for selinexor+ruxolitinib in myelofibrosis is planned for August, now the critical near-term catalyst.
Updates
· SEC 8-K — The 8-K adds that the FDA requires further discussion on data to support the sNDA and convert accelerated to traditional approval, and that Karyopharm is exploring financing transactions and strategic alternatives with Centerview Partners.
At the time of this announcement, KPTI was trading at $2.25 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $158.9M. The 52-week trading range was $3.65 to $10.99. This news item was assessed with negative market sentiment and an importance score of 9 out of 10. Source: Dow Jones Newswires.