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As of 8:10 PM 09/19/14 All times are local (Market data is delayed by at least 15 minutes).

incyte corp (INCY) Key Developments

FDA Accepts Incyte's Supplemental New Drug Application for Jakafi(R) (ruxolitinib) and Priority Review Granted

Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera (PV) 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 (ASCO) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA. The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ruxolitinib is set for December 5, 2014. PV is a form of blood cancer leading to the overproduction of normal red blood cells, white blood cells and platelets. Patients with uncontrolled PV have an increased risk of cardiovascular complications such as stroke, pulmonary embolism, deep vein thrombosis and heart attack. Jakafi is the first and only FDA-approved treatment for patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post--polycythemia vera MF and post--essential thrombocythemia MF. Ruxolitinib is also the first JAK1/JAK2 inhibitor to demonstrate efficacy in a Phase III trial in patients with polycythemia vera and, if approved, would be the first JAK1/JAK2 inhibitor made available to patients with polycythemia vera in the U.S.

Incyte Corporation Reports Unaudited Consolidated Financial Results for the Second Quarter and Six Months Ended June 30, 2014; Provides Earnings Guidance for Fiscal 2014

Incyte Corporation reported unaudited consolidated financial results for the second quarter and six months ended June 30, 2014. For the quarter, total revenues were $99,582,000 against $101,675,000 for the same period of last year. Loss from operations was $26,187,000 against income of $17,319,000 for the same period of last year. Loss before income taxes was $36,803,000 against $2,500,000 for the same period of last year. Net loss was $36,873,000 against $2,571,000 for the same period of last year. Net loss per basic and diluted share was $0.22 against $0.02 for the same period of last year. For the six months, total revenues were $189,374,000 against $172,752,000 for the same period of last year. Loss from operations was $49,123,000 against income of $13,222,000 for the same period of last year. Loss before income taxes was $70,711,000 against $18,127,000 for the same period of last year. Net loss was $70,830,000 against $18,240,000 for the same period of last year. Net loss per basic and diluted share was $0.43against $0.13 for the same period of last year. The company now expects that 2014 net product revenues from Jakafi will be in the range of $330 million to $340 million, an increase from the previous range of $315 million to $335 million. This range excludes any product royalty revenues received from the Company's collaboration partner Novartis on sales of Jakavi(R) (ruxolitinib) outside the United States.

Incyte Corporation Announces Clinical Trial Agreement with Genentech to Evaluate Combination of Two Novel Cancer Immunotherapies

Incyte Corporation announced that it has entered into a clinical trial agreement with Genentech to evaluate the safety, tolerability and preliminary efficacy of Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, in combination with Genentech's PD-L1 immune checkpoint inhibitor, MPDL3280A, in patients with non-small cell lung cancer (NSCLC). Both INCB24360 and MPDL3280A are part of a new class of cancer treatments known as immunotherapies that are designed to enhance the body's own defenses in fighting cancer; both agents target distinct regulatory components of the immune system. Under the terms of the collaboration, Incyte and Genentech will collaborate on a non-exclusive basis to evaluate the combination. Incyte will be responsible for conducting the study and the results will be used to determine whether further clinical development of this combination is warranted.

FDA Approves Supplemental Labeling for Incyte Corporation's Jakafi to Include New Kaplan-Meier Overall Survival Curves as Well as Additional Safety and Dosing Information

Incyte Corporation announced that the U.S. Food & Drug Administration (FDA) has approved supplemental labeling for Jakafi(R) (ruxolitinib) to include new Kaplan-Meier overall survival curves as well as additional safety and dosing information. The new overall survival information is based on three-year data from the two pivotal Phase III trials, COMFORT-I and II, and shows that at three years the probability of survival for patients treated with Jakafi in COMFORT-I was 70% and for those patients originally randomized to placebo it was 61%. In COMFORT-II, at three years the probability of survival for patients treated with Jakafi was 79% and for patients originally randomized to best available therapy (BAT) it was 59%. Both Phase III trials allowed for crossover from the control arm to Jakafi, and the median time to crossover in COMFORT-I and COMFORT-II was 9 months and 17 months, respectively. All patients who crossed over to Jakafi continued to be grouped within their original randomized assignment for these overall survival analyses. The new product label also includes additional guidance on safety and dosing including information regarding the risk and management of tuberculosis, modified information regarding symptom exacerbation following interruption and discontinuation of Jakafi, and modified dosing guidelines regarding concomitant use with CYP3A4 inhibitors and fluconazole.

Incyte Corporation Announces Top-Line Results from RELIEF Trial of Ruxolitinib in Patients with Polycythemia Vera

Incyte Corporation announced top-line results from RELIEF, a randomized, double-blind clinical trial designed to compare symptom improvement in 110 patients with polycythemia vera (PV) treated with ruxolitinib versus patients treated with hydroxyurea (HU). While positive trends were observed in favor of ruxolitinib, the trial did not achieve statistical significance for the primary endpoint as measured by the proportion of patients with >= 50% reduction in a defined cluster of symptoms that included tiredness, itching, muscle aches, night sweats and sweats while awake at week 16 compared to baseline. Topline results showed a 43.4% symptom response rate in the ruxolitinib arm and a 29.6% symptom response rate in the hydroxyurea arm (p=0.139). Full data from the RELIEF trial are expected to be presented at an upcoming scientific meeting. Further analyses of RELIEF are underway to evaluate what factors may have contributed to a symptom control rate for patients on stable doses of HU that was five to six times higher than that seen in the best available therapy control arm of the RESPONSE trial, and which led to an underpowering of the RELIEF trial. RESPONSE was an open-label randomized trial of 222 patients and is the basis of Incyte's supplemental New Drug Application (sNDA) submitted in June 2014. RESPONSE was conducted under a Special Protocol Assessment (SPA) agreement. The FDA granted Fast Track designation for ruxolitinib in PV, specifically for the treatment of patients who are resistant to or intolerant of hydroxyurea. If approved, ruxolitinib would be the first JAK1/JAK2 inhibitor available for patients with PV.

 

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