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June 3, 2014
10:47 EDTINCYIncyte announces results from RESPONSE trial evaluating ruxolitinib
Incyte announced results from the RESPONSE trial, the first pivotal Phase III study evaluating a JAK1/JAK2 inhibitor for the treatment of polycythemia vera. Ruxolitinib, compared to best available therapy (BAT), significantly improved hematocrit control without the need for phlebotomy and reduced spleen size in patients with uncontrolled PV. Findings from the RESPONSE study are being presented in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology. At a median follow-up of 81 weeks, 85% of patients in the ruxolitinib arm were still receiving treatment. Because most patients in the BAT group crossed over to receive ruxolitinib therapy at week 32, adverse events were evaluated at this time when exposure between groups was similar. The most common non-hematologic adverse events of any grade in the ruxolitinib group compared to the BAT group were headache, diarrhea, fatigue and pruritus. The company said, “One out of four patients with polycythemia vera remain uncontrolled, face a profound symptom burden and are at greater risk of cardiovascular complications such as stroke and heart attack. These Phase III data give us confidence that ruxolitinib has the potential to become an important new treatment option for patients with uncontrolled PV who are no longer responding to or are intolerant of hydroxyurea.”
News For INCY From The Last 14 Days
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December 12, 2014
08:01 EDTINCYPiper predicts two large-cap biotechs could be acquired in 2015
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December 9, 2014
07:11 EDTINCYEli Lilly and Incyte announce Phase 3 RA-BEACON study met primary endpoint
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December 8, 2014
13:07 EDTINCYNovartis announces data from Jakavi trial
Novartis (NVS) announced data from the largest clinical trial of myelofibrosis patients treated with Jakavi, supporting the safety profile and efficacy benefit as measured in primary and secondary endpoints respectively. In an analysis of 1,144 patients treated with Jakavi to date in this ongoing expanded access study, 69% of patients achieved >50% reduction in spleen size from baseline and patients also experienced a clinically meaningful improvement in myelofibrosis symptom score, important treatment goals for patients with myelofibrosis. Findings from the study were presented at the 56th Annual Meeting of the American Society of Hematology in San Francisco, California. Novartis research and development efforts, in collaboration with Incyte Corporation (INCY), include early-phase and post-marketing studies in myelofibrosis and other myeloproliferative neoplasms. More than 50 abstracts on ruxolitinib are being presented at ASH, including three oral presentations exploring combinations of ruxolitinib with various investigational compounds, evaluating the possibility of simultaneously targeting multiple cancer pathways that may be involved in the pathogenesis of myelofibrosis. The JUMP study is a Phase IIIb, expanded-access trial for countries with no access to Jakavi outside of a clinical trial. The open-label, multicenter study analyzed 1,144 enrolled myelofibrosis patients who received daily starting doses of either 5 mg, 15 mg or 20 mg of Jakavi twice daily based on platelet counts at baseline. The primary endpoint is assessment of safety and tolerability of Jakavi. Overall, the safety and efficacy profile of Jakavi was consistent with previous studies.
December 5, 2014
16:40 EDTINCYDiplomat Pharmacy: FDA approves expanded indication of Jakafi
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09:49 EDTINCYIncyte polycythemia vera approval another upside driver, says UBS
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07:16 EDTINCYFDA PDUFA Date for Incyte's Jakafi (Ruxolitinib) is December 5, 2014
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