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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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March 2, 2015
07:31 EDTINCYIncyte appoints Steven Stein as Chief Medical Officer
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February 26, 2015
07:37 EDTINCYIncyte to sponsor U.S. polycythemia vera study
Incyte announced that it is sponsoring the first major observational study of patients living with polycythemia vera in the U.S. PV is a rare and progressive blood cancer that can lead to debilitating symptoms, serious cardiovascular complications, and death.The REVEAL study will seek to describe the real-world clinical burden of PV and how healthcare services are utilized in the management of this disease. Incyte is partnering with approximately 200 community and academic medical centers to conduct the study in the U.S. REVEAL, which recently began enrolling patients, is expected to include 2,000 patients under the supervision of a physician for the active management of PV for a period of three years.
February 23, 2015
07:30 EDTINCYIncyte price target raised to $89 from $75 at Oppenheimer
Oppenheimer increased its price target on Incyte after the company reported that sales of its flagship Jakafi drug had jumped 46% year-over-year in Q4. The firm continues to be upbeat on Jakafi's revenue outlook and the company's pipeline. It keeps an Outperform rating on the shares.
07:06 EDTINCYEli Lilly and Incyte announces positive results for baricitinib
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February 18, 2015
08:13 EDTINCYIncyte shares poised to rise further, says Argus
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