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incyte corp (INCY) Key Developments

Incyte Corporation Announces Positive Top-Line Results from Phase III Study of Ruxolitinib in Patients with Polycythemia Vera

Incyte Corporation announced that a pivotal Phase III trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea has met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35% or more. The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data. Ruxolitinib, marketed as Jakafi(R) (ruxolitinib) in the United States, is approved to treat people with intermediate or high-risk myelofibrosis (MF), including primary MF, post--polycythemia vera MF and post--essential thrombocythemia MF. The global, randomized, open-label Phase III trial, called RESPONSE, was conducted at 109 sites. The trial included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib (10 mg twice-daily) or best available therapy. The dose was adjusted as needed throughout the trial. The primary endpoint of the trial is the proportion of patients whose hematocrit level is controlled in absence of phlebotomy and whose spleen volume is reduced by 35% or more from baseline as assessed by imaging at 32 weeks. In addition to safety, key secondary endpoints include durable response and complete hematological remission. Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) characterized by an overproduction of normal red blood cells, white blood cells and platelets that leads to an increased risk of thrombosis. Erythrocytosis (elevated red blood cell mass) is the most prominent clinical manifestation of PV, distinguishing it from other MPNs. PV may occur at any age but often presents later in life, with a median age at diagnosis of 60 years. Approximately 100,000 patients in the United States are living with PV and approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered uncontrolled.

Incyte Corporation Presents at Barclays Capital 2014 Global Healthcare Conference, Mar-11-2014 11:15 AM

Incyte Corporation Presents at Barclays Capital 2014 Global Healthcare Conference, Mar-11-2014 11:15 AM. Venue: Loews Miami Beach Hotel, Miami, Florida, United States. Speakers: Herve Hoppenot, Chief Executive Officer, President and Director.

Incyte Corporation Announces Unaudited Consolidated Earnings Results for the Fourth Quarter and Year Ended December 31, 2013; Provides Financial Guidance for 2014

Incyte Corporation announced unaudited consolidated earnings results for the fourth quarter and year ended December 31, 2013. For the quarter, the company reported total revenues of $97,072,000 compared to $113,845,000 a year ago. Loss from operations was $16,143,000 compared to income from operations of $30,254,000 a year ago. Loss before income taxes was $42,733,000 compared to income before income taxes of $18,860,000 a year ago. Net loss was $42,870,000 or $0.26 per basic and diluted share compared to net income of $18,779,000 or $0.14 per basic and diluted share a year ago. Adjusted net loss was $24,936,000 or $0.15 per basic and diluted share. Included in the net loss for the quarter ended December 31, 2013, was a one-time charge of $17.9 million, or $0.11 per basic and diluted share, related to the repurchase of $117.3 million face amount of the Company's 4.75% Convertible Senior Notes due 2015. For the year, the company reported total revenues of $354,947,000 compared to $297,059,000 a year ago. Loss from operations was $16,102,000 compared to income from operations of $1,148,000 a year ago. Loss before income taxes was $82,848,000 compared to $44,146,000 a year ago. Net loss was $83,147,000 or $0.56 per basic and diluted share compared to $44,320,000 or $0.34 per basic and diluted share a year ago. Adjusted net loss was $65,213,000 or $0.44 per basic and diluted share. The increase in net loss from 2012 to 2013 is primarily due to $11.5 million in debt exchange expense for senior note conversions related to separately negotiated agreements with certain holders of the 2015 Notes, and a $17.9 million one-time charge, or $0.12 per basic and diluted share, related to the repurchase of $117.3 million face amount of the 2015 Notes. For 2014, the company expects that Jakafi net product revenues will be in the range of $315 million to $335 million. This range excludes any product royalty revenues received from Novartis on sales of Jakavi. Contract revenues: The company expects to receive a $60 million milestone payment under its collaboration agreement with Novartis when European Union pricing approval for Jakavi is received in a third major European country. Excluding any other potential milestones received under collaborations, the company expects revenues of approximately $13 million from the amortization of the upfront payments received under its collaboration agreement with Lilly. Research and Development Expenses: The Company expects that research and development expenses will be in the range of $350 million to $370 million, including a non-cash expense of approximately $30 million to $35 million related to the impact of expensing employee stock options. The increase in research and development is primarily related to broad investment in the clinical pipeline, including the advancement of ruxolitinib and JAK1 inhibitor, INCB39110, in solid tumors and the development of IDO1 inhibitor, INCB24360, in multiple oncologic indications in combination with checkpoint inhibitors. Selling, general and administrative expenses: The company expects selling, general and administrative expenses to be in the range of $145 million to $155 million, including a non-cash expense of approximately $28 million to $30 million related to the impact of expensing employee stock options. The increase in selling, general and administrative expenses is primarily the result of additional programs to support the ongoing commercialization of Jakafi in MF and preparation for the anticipated launch in polycythemia vera. Interest expense: The company expects interest expense to be approximately $48 million, including a non-cash expense of $37 million related to the amortization of the discount on the 2015 Notes, 2018 Notes and 2020 Notes.

Incyte Corporation Announces Clinical Trial Collaboration with Merck to Evaluate Combination of Two Novel Immunotherapies

Incyte Corporation announced that it has entered into a clinical trial collaboration agreement with Merck, through a Merck subsidiary, to evaluate the safety and efficacy of Incyte's oral indoleamine dioxygenase-1 inhibitor, INCB24360, and Merck's investigational anti-PD-1 immunotherapy, MK-3475, in a Phase I/II study in previously treated metastatic and recurrent non-small cell lung cancer, and other advanced or metastatic cancers. Both INCB24360 and MK-3475 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. INCB24360 and MK-3475 target distinct regulatory components of the immune system, and there is preclinical evidence suggesting that the combination of these two agents may lead to an enhanced anti-tumor immune response than either agent alone. Under the terms of the agreement, Incyte and Merck will collaborate on a Phase I/II study to evaluate the safety and efficacy of the combination in previously treated metastatic and recurrent NSCLC, and other advanced or metastatic cancers. The Phase I portion of the trial is expected to establish a recommended dose regimen of INCB24360 and MK-3475. In the Phase II portion of the study, all patients receive MK-3475 and patients will be randomized to receive either INCB24360 or matching placebo. The study, which is expected to begin in the first half of 2014, will be co-funded by Incyte and Merck and conducted by Incyte. Results from this first study with Merck will be used to determine whether further clinical development of this combination is warranted. INCB24360 is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays, 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 efficacious 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. Many tumors are able to evade the immune system through a mechanism that exploits the PD-1 inhibitory checkpoint protein. MK-3475 is an investigational, highly selective anti-PD-1 immunotherapy designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system's T-cells that target cancer by essentially releasing a brake on the immune system.

Merck Enters Strategic Collaborations with Amgen, Incyte and Pfizer to Evaluate Novel Combination Anti-Cancer Regimens with MK-3475

Merck announced that it has signed three separate clinical collaboration agreements, through subsidiaries, with Amgen Inc., Incyte Corporation and Pfizer Inc. to evaluate novel combination regimens with MK-3475, Merck's investigational anti-PD-1 immunotherapy. The financial terms of the agreements were not disclosed. Planned investigations include: Pfizer and Merck will evaluate in Phase I/II clinical studies the safety and efficacy of MK-3475 in combination with Pfizer's small molecule kinase inhibitor axitinib (INLYTA(R)) in patients with renal cell carcinoma, and separately MK-3475 plus PF-05082566 (PF-2566), an investigational immuno-oncology agent that targets the human 4-1BB receptor, in multiple cancer types. Incyte and Merck will collaborate on a randomized, double-blind placebo controlled Phase I/II study to evaluate the safety and efficacy of a regimen combining MK-3475 with Incyte's investigational immunotherapy agent, INCB24360, an indoleamine 2, 3-dioxygenase (IDO) inhibitor, in patients with previously treated metastatic and recurrent NSCLC, among other advanced or metastatic cancers. Amgen and Merck will evaluate MK-3475 in combination with Amgen's investigational oncolytic immunotherapy talimogene laherparepvec in a Phase I/II study in patients with previously untreated advanced melanoma. Separately, Merck announced it will start a new Phase I 'signal finding' study to evaluate the safety and efficacy of MK-3475 monotherapy in 20 different PD-L1-positive solid tumor types that have not been studied previously (clinical trials identifier: NCT02054806).

 

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