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Karyopharm gets bump as FDA extends review of selinexor

March 15, 2019 2:29 PM UTC

Karyopharm gained 7% on Friday after it said FDA has extended by three months its review of selinexor, which is under Priority Review to treat multiple myeloma. Its PDUFA date is now July 6.

Karyopharm Therapeutics Inc. (NASDAQ:KPTI) said it has submitted additional clinical information upon the agency's request, allowing FDA to extend the review. An advisory committee voted 8-5 last month that FDA should wait for the results of the Phase III BOSTON trial before making a decision on selinexor's approval. Top-line data from that study could be available as soon as late 2019 (see "ODAC Backs Delay for Karyopharm's Selinexor")...

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