FDA or­ders Karyopharm to halt en­roll­ment for all se­linex­or tri­als, cit­ing in­com­plete safe­ty warn­ing

Late Fri­day night Karyopharm Ther­a­peu­tics $KPT alert­ed in­vestors that the FDA has slapped a par­tial hold on all stud­ies in­volv­ing its lead can­cer drug se­linex­or, halt­ing en­roll­ment for work on a drug that was re­cent­ly tapped for a 2018 fil­ing with the FDA.

Reg­u­la­tors or­dered the par­tial hold af­ter cit­ing, in writ­ing, in­com­plete in­for­ma­tion in a brochure on the drug which in­clud­ed an in­com­plete list of the ad­verse events as­so­ci­at­ed with the drug. The state­ment does not say when the agency first in­formed the com­pa­ny of the par­tial hold, but Karyopharm says that as of Fri­day the com­pa­ny has sup­plied the in­for­ma­tion re­quest­ed to get the hold lift­ed.

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