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ARTICLE | Company News

Karyopharm down as FDA reviewers cast doubt on selinexor's benefit

February 22, 2019 10:19 PM UTC

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) lost $3.90 (43%) to $5.07 on Friday after FDA reviewers wrote in briefing documents that it is unclear whether treatment with selinexor provides a clinically meaningful benefit that outweighs the risks of treatment.

Karyopharm's NDA for selinexor, which is under Priority Review with a PDUFA date of April 6, is seeking accelerated approval of the product to treat relapsed/refractory multiple myeloma. The application is based on data from the open-label, single-arm Phase IIb STORM trial, in which selinexor plus low-dose dexamethasone led to an overall response rate (ORR) of 25.4% in penta-refractory MM patients...

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