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News Breaks
August 5, 2014
07:41 EDTINCYIncyte says FDA accepts sNDA for Jafaki
Incyte Corporation announced that the U.S. FDA has accepted for filing the supplemental New Drug Application for ruxolitinib as a potential treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology annual meeting. RESPONSE was conducted under a Special Protocol Assessment from the FDA. The Prescription Drug User Fee Act date for the sNDA for ruxolitinib is set for December 5, 2014.
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March 26, 2015
10:10 EDTINCYAnalyst calls sharp pullback in biotech stocks 'misguided'
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06:45 EDTINCYBiotech valuation concerns 'misguided,' says Piper Jaffray
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March 17, 2015
05:32 EDTINCYIncyte announces Novartis receives EC approval for Jakavi
Incyte (INCY) announced that Novartis (NVS) received approval from the European Commission for Jakavi for the treatment of adult patients with polycythemia vera, or PV, who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients. Under the Incyte-Novartis Collaboration and License Agreement signed in 2009, Novartis received exclusive development and commercialization rights to ruxolitinib outside of the United States for all hematologic and oncologic indications, and sells ruxolitinib under the name Jakavi. Ruxolitinib is marketed by Incyte in the United States as Jakafi. Jakafi is approved by the FDA for treatment of people with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

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