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ARTICLE | Clinical News

CTI withdraws pacritinib NDA

February 11, 2016 1:14 AM UTC

CTI BioPharma Corp.(NASDAQ:CTIC; Milan:CTIC) withdrew its NDA for pacritinib ( BAX 2201) after FDA placed a full clinical hold on the candidate's IND. On Wednesday, CTI shed $0.20 (40%) to $0.30 on NASDAQ and EUR 0.19 (40%) to EUR 0.27 in Milan.

CTI said FDA noted a "detrimental effect on survival" in pacritinib-treated patients in the Phase III PERSIST-2 trial to treat myelofibrosis. The company said deaths in the trial were due to intracranial hemorrhage, cardiac failure and cardiac arrest. ...