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Tuesday, February 26, 2019

Karyopharm says stock halted, FDA’s ODAC meeting over selinxeor NDA

Karyopharm Therapeutics Inc. announced that NASDAQ has halted trading of the Company’s common stock. The U.S. Food and Drug Administration Oncologic Drugs Advisory Committee is holding a meeting today from 12:30 p.m. to 5:00 p.m. ET to discuss Karyopharm’s New Drug Application requesting accelerated approval for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export compound. The proposed indication to be discussed at this ODAC meeting is for selinexor in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.
https://thefly.com/landingPageNews.php?id=2870513

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