KPTI - Karyopharm cancer therapy eltanexor gets FDA fast track status orphan drug tag in EU

• Karyopharm Therapeutics ( NASDAQ: KPTI ) said eltanexor was granted fast track designation by the U.S. Food and Drug Administration (FDA) as monotherapy to treat patients with relapsed or refractory intermediate, high-, or very high-risk myelodysplastic syndromes (MDS).
• In addition, the European Commission granted orphan medicinal product designation to eltanexor to treat patients with MDS in the EU.
• The EC grants orphan drug status to therapies aimed at treating or preventing diseases that affect less than 5 in 100K people in the EU. The designation has benefits, including 10 years of market exclusivity for the product, if approved.
• The company noted that it had also received orphan drug designation from the FDA in January 2022.
• MDS are a group of cancers in which immature blood cells in the bone marrow do not become mature or become healthy blood cells.
• KPTI +2.35% to $4.80 premarket July 20

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