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incyte corp (ICY) Details

Incyte Corporation, a biopharmaceutical company, focuses on the discovery, development, and commercialization of proprietary small molecule drugs primarily for oncology and inflammation. The company markets JAKAFI, an oral janus associated kinase (JAK) inhibitor for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF. Its product pipe line includes ruxolitinib, a JAK inhibitor, which is in Phase III clinical trial for polycythemia vera; in Phase II trial for pancreatic cancer; and in Phase I trial for the treatment of malignancies, as well as baricitinib, a JAK inhibitor, which is in Phase III trial for rheumatoid arthritis, in Phase IIb trial for psoriasis, and in Phase II trial for diabetic nephropathy. The company’s products in pipeline also comprise INC280, which is in Phase II clinical trial for the treatment of solid tumors, hepatocellular carcinoma, and non-small cell lung cancer; and INCB24360 that is in Phase II clinical trial for the treatment of metastatic melanoma and ovarian cancer; INCB40093 and INCB39110+INCB40093, which are Phase I clinical trial products for the treatment of B-lymphoid malignancies; INCB39110 that is in Phase II for myelofibrosis treatment and in Phase I for the treatment of malignancies; and INCB47986, which is in Phase I clinical trial products for the treatment of rheumatoid arthritis. It has a collaborative research and license agreements with Novartis International Pharmaceutical Ltd.; Eli Lilly and Company; and Pfizer Inc., as well as strategic collaboration arrangement with Merck. The company was founded in 1991 and is headquartered in Wilmington, Delaware.

481 Employees
Last Reported Date: 02/21/14
Founded in 1991

incyte corp (ICY) Top Compensated Officers

Chief Financial Officer and Executive Vice Pr...
Total Annual Compensation: $357.6K
Chief Commercial Officer and Executive Vice P...
Total Annual Compensation: $506.6K
Chief Drug Development & Medical Officer and ...
Total Annual Compensation: $373.4K
Executive Vice President of Human Resources
Total Annual Compensation: $354.0K
Compensation as of Fiscal Year 2013.

incyte corp (ICY) Key Developments

Incyte Corporation Presents at JMP Securities Healthcare Conference, Jun-25-2014 11:00 AM

Incyte Corporation Presents at JMP Securities Healthcare Conference, Jun-25-2014 11:00 AM. Venue: The Westin New York Grand Central, 212 East 42nd Street, New York, NY 10017, United States.

Incyte Corporation Announces Results from the RESPONSE Trial

Incyte Corporation announced results from the RESPONSE trial, the first pivotal Phase III study evaluating a JAK1/JAK2 inhibitor for the treatment of polycythemia vera (PV). Ruxolitinib, compared to best available therapy (BAT), significantly improved hematocrit control (red blood cell volume) without the need for phlebotomy (a procedure to remove blood from the body to reduce the concentration of red blood cells) and reduced spleen size in patients with uncontrolled PV -- those who are resistant to or intolerant of hydroxyurea (HU). Findings from the RESPONSE study are being presented in an oral presentation at the 50th Annual Meeting of the American Society of Clinical Oncology in Chicago. Data from the RESPONSE trial demonstrated that treatment with ruxolitinib can consistently control hematocrit, reduce spleen size, and improve symptoms such as fatigue and itching. Importantly, there appears to be a lower rate of thrombosis in the ruxolitinib arm compared to best available therapy. 77% of ruxolitinib-treated patients versus 20% on BAT achieved at least one component of the primary endpoint: hematocrit control from week 8 to 32 and/or at least a 35% reduction in spleen volume. A greater proportion of patients treated with ruxolitinib achieved the composite primary endpoint compared to BAT (21% versus 1%, respectively; P< 0.0001); 91% of patients in the ruxolitinib group achieving this endpoint maintained their response at week 48. A greater proportion of patients in the ruxolitinib treatment arm had complete hematologic remission, a key secondary endpoint, when compared to the BAT arm (24% compared to 9%, P=0.003). Patients treated with ruxolitinib also experienced meaningful improvements in PV-related symptoms: 49%, compared to 5% treated with BAT, had a 50% or greater improvement in symptom score at week 32 as measured by the 14-item MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form). At week 32, one patient in the ruxolitinib group and six in the BAT group had a thromboembolic event. 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 (16.4% versus 18.9%), diarrhea (14.5% versus 7.2%), fatigue (14.5% versus 15.3%), and pruritus (13.6% versus 22.5%). Based on laboratory assessments, the rates of new or worsening grade 3 or 4 anemia and thrombocytopenia in the ruxolitinib group versus the BAT group were 1.8% versus 0% and 5.5% versus 3.6%, respectively. These data will support global regulatory filings anticipated this year, including a submission to the U.S. Food and Drug Administration expected this month.

Incyte Corporation Announces Preliminary Results of a Phase I/II Study of Combination Immunotherapy in Patients with Melanoma

Incyte Corporation announced that preliminary results from an ongoing Phase I/II study of INCB24360, its oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, combined with ipilimumab in patients with unresectable or metastatic melanoma were presented at the 50(th) Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 to June 3, 2014, in Chicago. The poster reported initial findings showing that the combination was generally well tolerated and produced evidence of clinical response. In the study, 42% (5/12) of immunotherapy-naïve patients who received ipilimumab with INCB24360 at 25 mg or 50 mg twice-daily demonstrated an objective response (complete response + partial response) and 75% (9/12) achieved disease control (complete response + partial response + stable disease) as assessed using immune-related response criteria (irRC). One patient with pulmonary metastases treated with ipilimumab and INCB24360 50 mg twice-daily experienced a complete response. Immune-related adverse events observed in these cohorts were generally mild-to-moderate (Grade 1 or Grade 2). Grade 3 or 4 immune related adverse events were qualitatively similar to ipilimumab monotherapy and were generally manageable and reversible. The poster for this presentation can be accessed at 2014 ASCO - INCB24360 poster. The ASCO presentation described results from the open-label, dose escalation portion of the ongoing Phase I/II study evaluating the combination of a standard regimen of ipilimumab with oral INCB24360. Study endpoints included safety and tolerability, objective response rate (assessed using irRC and RECIST 1.1 criteria every nine weeks), duration of response, overall and progression-free survival, and IDO1 inhibition. Additional Safety and Efficacy Findings were Initially, seven patients were enrolled in a cohort receiving ipilimumab with INCB24360 300 mg twice-daily. Five of these patients developed clinically significant (Grade 3 or 4) alanine aminotransferase (ALT) elevations and enrollment was stopped. The ALT elevations observed in the patients receiving the 300 mg dose were reversible with corticosteroids and treatment discontinuation. Although all patients in the 300 mg twice-daily cohort were discontinued before response could be fully evaluated, six of the seven patients were alive after one year, including three who have not received subsequent checkpoint inhibitor immunotherapy. The study was amended to evaluate lower doses of INCB24360. Seventeen patients were enrolled in the INCB24360 25 mg twice-daily and 50 mg twice-daily cohorts. During the dose limiting toxicity (DLT) observation periods, one patient in the 25 mg cohort who had extensive liver metastases prior to entering the trial experienced a DLT (Grade 3 AST elevation), and two patients in the 50 mg cohort experienced a DLT (Grade 3 diarrhea and Grade 3 ALT elevation). In both cohorts, immune-related treatment-emergent adverse events were generally Grade 1 or Grade 2 and manageable with continued dosing or temporary dose interruption. Twelve patients who were treatment-naïve for advanced or metastatic disease were enrolled in the INCB24360 25 mg twice-daily and 50 mg twice-daily cohorts. Eight of these immunotherapy-naïve patients experienced a reduction in tumor burden, and most reductions were durable with continued therapy. As of the data cutoff, the majority of immunotherapy-naïve patients are continuing on study therapy or have experienced a prolonged period without the need for subsequent therapy. Of the five patients who received prior immunotherapy for advanced or metastatic disease, two (40%) achieved stable disease by irRC. Duration of disease control ranged from 60 to more than 379 days (ongoing). Pharmacodynamic effects with INCB24360 25 mg BID and 50 mg BID were similar to those that were sufficient in preclinical models to achieve maximal therapeutic effect. IDO1 inhibition in this study was consistent with that observed in the phase I open-label study,(1) suggesting that there was no pharmacodynamic interaction with ipilimumab. Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. INCB24360 is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. INCB24360 has been shown to be active in mouse models of cancer as a single agent and in combination with cytotoxic and immunotherapy agents, and its ability to reduce tumor growth is dependent on a functional immune system -- consistent with its proposed mechanism of action. A Phase I dose-escalation trial demonstrated that INCB24360 results in greater than 90% inhibition of IDO1 activity at generally well-tolerated doses.


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