Shares of Karyopharm Therapeutics (KPTI) are jumping in early trading amid indications that the company’s selinexor tablets, to be marketed as Xpovio, have received approval from the FDA. A copy of what appears to be the Xpovio prescribing information has been shared on Twitter and the document indicates an initial U.S. approval date of July 2019. The document, which says that Xpovio is a nuclear export inhibitor indicated in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody, does not include a “black box” warning, some on Twitter have noted. Additionally, a website for Xpovio has been set up and that site announces that the drug is “now approved.” The Fly notes that the FDA’s PDUFA date for selinexor is on July 6. In morning trading, Karyopharm shares are up 32%, or $2.11, to $8.65.
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