Karyopharm stock soars on selinexor's positive PhIIb update, plans for an NDA
After spooking some investors who were waiting all day for a promised trial update — and sending its stock down 14% on the perceived delay — Karyopharm Therapeutics $KPTI finally rolled out new data on its lead cancer drug selinexor after market close Monday. Investors appear to be happy with the news after all, boosting the stock price 26% in after-hours trading.
The drug was being tested among multiple myeloma patients who had proved resistant to a long slate of drugs, an indication of just how crowded MM has grown in recent years. In this data update — the second from Karyopharm’s Phase IIb trial called STORM — selinexor achieved a 25.4% overall response rate, which included two complete responses and 29 partial or very good partial responses in patients. The median duration of response, a key secondary objective, was 4.4 months.
The Newton, MA-based biotech plans to submit an NDA to US regulators during the second half of 2018, along with an application to the EMA in early 2019.
“Penta-refractory myeloma is an area of true unmet medical need as these patients have continued to progress despite receiving available therapies,” said Sharon Shacham, founder, president, and CSO of Karyopharm, in a statement. “We are fully committed to bringing this new, orally administered potential treatment option to patients who have no other therapy options of proven benefit. To our knowledge, oral selinexor is the most advanced agent being investigated in patients with penta-refractory myeloma and we look forward to submitting our NDA to the FDA during the second half of this year, with a submission to the EMA to follow.”