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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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April 21, 2015
05:57 EDTINCYIncyte price target raised to $121 from $80 at Piper Jaffray
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April 20, 2015
08:47 EDTINCYIncyte price target raised to $120 from $93 at SunTrust
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April 17, 2015
07:33 EDTINCYIncyte no longer expects to initiate INCB39110 trial in pancreatic cancer in '15
Incyte Corporation announced that eleven abstracts detailing its emerging development pipeline will be presented at the 2015 American Association for Cancer Research Annual Meeting in Philadelphia, PA. These abstracts include characterizations of Incyte’s FGFR, BRD and PIM inhibitors as potential targeted therapies for cancer, as well as data supporting the potential immuno-therapeutic activity of the company’s portfolio of JAK and PI3Kδ inhibitors alone and in combination, including with epacadostat, Incyte’s leading IDO1 inhibitor. The company also provided an updated presentation of its clinical portfolio, which now includes INCB54828, a potent and selective FGFR inhibitor and INCB50465, a PI3Kδ inhibitor, which entered clinical trials in Q1 2015 for solid tumors and B-lymphoid malignancies. INCB54329, a bromodomain inhibitor, is expected to enter clinical trials in Q2 2015 in hematology oncology. Additional first-line pancreatic cancer patients are being recruited into the expansion cohort of JAK1-selective inhibitor INCB39110 in combination with gemcitabine and nab-paclitaxel to continue the dose optimization phase of this proof-of-concept trial. Incyte therefore no longer expects to initiate a pivotal trial of INCB39110 in first-line pancreatic cancer during 2015.
April 14, 2015
07:31 EDTINCYIncyte to establish European headquarters in Geneva, Switzerland
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