CTI's pacritinib on partial clinical hold

CTI BioPharma Corp. (NASDAQ:CTIC; Milan:CTIC) fell $0.68 (61%) to $0.44 on Monday after it said FDA placed a partial clinical hold on on pacritinib ( BAX 2201), citing "excess mortality and other adverse events" in the Phase III PERSIST-1 study. Last month, CTI and partner Baxalta Inc. (NASDAQ:BXLT) completed submission of a rolling NDA to FDA for pacritinib to treat patients with intermediate- and high-risk myelofibrosis (MF) with low platelet counts of <50,000/uL. PERSIST-1 was included in the NDA.

CTI said FDA observed an increased risk of adverse events in pacritinib-treated patients vs. control in the trial, with excess mortality most evident during a crossover period in which control-treated patients could switch to pacritinib. ...