Karyopharm Submits sNDA for XPOVIO Combo in Myelofibrosis, Seeks Priority Review
KPTI is trading near its 52-week low of $1.79 (6.7% above the low).
Summary
Karyopharm has submitted a supplemental New Drug Application to the FDA for XPOVIO (selinexor) combined with ruxolitinib in myelofibrosis, requesting Priority Review and Accelerated Approval. This follows the Phase 3 SENTRY trial results presented earlier this year, which showed compelling spleen responses and a promising overall survival signal. The company expects to hear about filing acceptance and review timelines in Q4 2026. With a cash runway only into September 2026 and substantial doubt about its ability to continue as a going concern, this regulatory milestone is critical for the company's survival and could unlock a significant new market opportunity. The FDA's decision on whether to accept the filing and grant priority review will be the next major catalyst.
At the time of this announcement, KPTI was trading at $1.91 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $42.4M. The 52-week trading range was $1.79 to $10.99. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: PR Newswire.