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February 20, 2013
08:41 EDTONXXOnyx Pharmaceuticals announces results from Phase 2 trial of Kyprolis
Onyx Pharmaceuticals announced that Leukemia has published results from the Phase 2 trial known as PX-171-005, an open-label, multicenter clinical trial evaluating Kyprolis for Injection in patients with relapsed and refractory multiple myeloma and varying degrees of renal insufficiency. About the PX-171-005 Study Fifty patients with relapsed, refractory and/or progressive multiple myeloma who had received at least two prior therapeutic regimens were enrolled in the open-label, single-agent, multicenter Phase 2 trial, and 47 were evaluable for response. The authors reported on the primary and secondary endpoints of the trial. The primary endpoint was the influence of renal impairment on the pharmacokinetics, or PK, of carfilzomib. Statistical comparisons showed no differences between renal function status and the dose-adjusted PK parameters including apparent plasma clearance, dose-normalized AUCinf, and the dose-normalized Cmax. Secondary outcomes included safety, tolerability, pharmacodynamic measures, and efficacy. The most common treatment-emergent adverse events, or AEs, reported in this study were fatigue and anemia, and the most common Grade 3/4 AEs were anemia, thrombocytopenia. The most common AEs of any grade possibly related to carfilzomib were fatigue, anemia, nausea, and diarrhea.
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May 8, 2013
08:52 EDTONXXOnyx Pharmaceuticals price target raised to $115 from $105 at Maxim
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May 7, 2013
16:01 EDTONXXOnyx Pharmaceuticals reports Q1 EPS (47c), consensus (47c)
Reports Q1 revenue $145.5M, consensus $134.36M.

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