INCYTE CORPORATION (NASDAQ:INCY) Files An 8-K Other EventsItem 8.01 Other Events.
On April 14, 2017, Eli Lilly and Company and Incyte Corporation announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter for the New Drug Application of the investigational medicine baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis.
The letter indicates that the FDA is unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms. The companies disagree with the FDA’s conclusions. The timing of a resubmission will be based on further discussions with the FDA.
About INCYTE CORPORATION (NASDAQ:INCY)
Incyte Corporation is a biopharmaceutical company. The Company is focused on the discovery, development and commercialization of therapeutics to treat medical needs, primarily in oncology. The Company focuses on the research and development program to explore the inhibition of enzymes called janus associated kinases (JAK). The Company’s pipeline includes compounds in various stages, ranging from preclinical to late stage development, and a commercialized product, JAKAFI (ruxolitinib). The Company has discovered multiple potent, selective and orally bioavailable JAK inhibitors that are selective for JAK1 or JAK1 and JAK2. JAKAFI is the compound in its JAK program, which is an oral JAK1 and JAK2 inhibitor. JAKAFI orphan drug is indicated for Myelofibrosis (MF), Polycythemia Vera (PV) and essential thrombocythemia. The Company’s second oral JAK1 and JAK2 inhibitor is baricitinib. INCYTE CORPORATION (NASDAQ:INCY) Recent Trading Information
INCYTE CORPORATION (NASDAQ:INCY) closed its last trading session up +2.57 at 140.84 with 2,186,422 shares trading hands.