Karyopharm And Menarini Group Announce Orphan Medicinal Product Designation From The European Commission For Selinexor For The Treatment Of Myelofibrosis

Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group (“Menarini”), a privately-held, leading international pharmaceutical company, today announced that the European Commission (EC) has granted orphan medicinal product designation for selinexor for the treatment of myelofibrosis (MF). Selinexor was granted orphan drug designation in MF by the U. S. Food and Drug Administration (FDA) in May 2022. Karyopharm is currently evaluating selinexor, a first-in-class XP01 inhibitor, as monotherapy in patients with previously treated MF, and in combination with ruxolitinib in treatment-naïve patients. In December 2021, Karyopharm and Menarini entered into an exclusive licensing agreement whereby Menarini is responsible for commercializing all current and future indications of NEXPOVIO® in the European Economic Area, United Kingdom and Switzerland, CIS countries, Turkey and Latin America. Stemline Therapeutics B.V., a wholly owned subsidiary of Menarini, is leading all commercialization activities in Europe.