Incyte 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.
Incyte lowers FY15 Jakafi revenue view to $525M-$565M from $560M-$575M Lowers FY15 R&D expenses view to $450M-$500M from $475M-$500M. Lowers FY15 selling, general, and administrative expenses view to $180M-$200M from $195M-$210M.
Incyte price target raised to $125 from $115 at Leerink Leerink raised its price target for Incyte to $125 saying its survey of 49 U.S. hematologists indicated Jakafi has blockbuster potential in polycythemia vera. The firm keeps an Outperform rating on the stock.