What happened
Shares of Karyopharm Therapeutics (NASDAQ:KPTI), a clinical-stage biopharmaceutical business, rose 12.7% on Monday after investors had a chance to digest the company's latest investor presentation. Those still holding out hope for Karyopharm's lead candidate, selinexor, gave the stock its lift today.
So what
Karyopharm has a couple of new drug candidates in early-stage testing, but selinexor for multiple myeloma is the only one close to the finish line. Last month, the stock tanked after an independent advisory panel voted 8 to 5 in favor of pausing selinexor's FDA review until results from an ongoing phase 3 study become available near the end of the year.
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Last week, the Food and Drug Administration announced it would delay completing its review from April 6 to July 6. Investors didn't quite know what to make of the FDA's decision, because the phase 3 trial the agency wants to see complete data from isn't going to wrap up until the end of the year at the earliest.
Earlier today, the company presented its plan for selinexor, and despite a lack of new details, investors found it encouraging.
Now what
The FDA's decision to extend its review of selinexor for the treatment of multiple myeloma patients who have failed three prior lines of treatment probably isn't a positive sign. According to Karyopharm, the agency delayed the application in order to review additional clinical data the company had submitted. Delays of this sort aren't unusual, but all they really tell you is that the company didn't get it right the first time.
Those hoping the delay is a sign that the FDA hasn't already made up its mind will probably be disappointed. The FDA noted 10 fatal treatment-emergent events among just 123 patients in the Storm study, while only 25% of the group showed response to treatment. While a delay is better than a complete response letter, the odds of an approval based on the risk-to-benefit ratio for selinexor are not good.
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