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March 7, 2014
05:37 EDTINCYIncyte announces Phase III study of ruxolitinib meets primary endpoint
Incyte announced that a pivotal Phase III trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea has met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35% or more. The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data. Ruxolitinib, marketed as Jakafi in the United States, is approved to treat people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. The global, randomized, open-label Phase III trial, called RESPONSE, was conducted at 109 sites. The trial included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib or best available therapy. The dose was adjusted as needed throughout the trial. The primary endpoint of the trial is the proportion of patients whose hematocrit level is controlled in absence of phlebotomy and whose spleen volume is reduced by 35 percent or more from baseline as assessed by imaging at 32 weeks. In addition to safety, key secondary endpoints include durable response and complete hematological remission. Data from RESPONSE are expected to be presented at an upcoming scientific meeting and submitted to the FDA this year.
News For INCY From The Last 14 Days
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October 2, 2015
07:31 EDTINCYIncyte to present new data on immuno-oncology portfolio at SITC
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October 1, 2015
07:31 EDTINCYLeerink to hold a roundtable
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September 30, 2015
08:30 EDTINCYIncyte to join Nasdaq-100 Index beginning Oct. 7, to replace Altera
Nasdaq yesterday announced that Incyte Corporation (INCY), will become a component of the NASDAQ-100 Index and the NASDAQ-100 Equal Weighted Index prior to market open on Wednesday, October 7, 2015. Incyte Corporation will replace Altera Corporation (ALTR). Incyte Corporation is headquartered in Palo Alto, California, and has a market capitalization of approximately $19B.
September 29, 2015
06:47 EDTINCYEli Lilly and Incyte's baricitinib Phase 3 study met primary objective
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