Last $87.91 USD
Change Today -0.04 / -0.05%
Volume 756.1K
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As of 8:10 PM 03/4/15 All times are local (Market data is delayed by at least 15 minutes).

incyte corp (INCY) Key Developments

Incyte Corporation Appoints Steven H. Stein as Senior Vice President and Chief Medical Officer

Incyte Corporation announced that Steven H. Stein, MD, has been appointed Senior Vice President and Chief Medical Officer, effective immediately. Dr. Stein was formerly SVP, US Clinical Development & Medical Affairs at Novartis Oncology US, and he will be responsible for clinical and medical strategy and operations across Incyte’s extensive oncology portfolio. He will join the executive management team of Incyte, and report to Richard S. Levy, MD, Executive Vice President and Chief Drug Development Officer.

Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study

Eli Lilly and Company and Incyte Corporation announce that the investigational medicine baricitinib demonstrated a statistically significant improvement compared to placebo in a second consecutive Phase 3 trial in rheumatoid arthritis (RA). The RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug (cDMARD). The study met its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment. Part of an extensive Phase 3 program testing baricitinib in more than 3,000 patients at different stages along the RA treatment continuum, the RA-BUILD study enrolled 684 patients with rheumatoid arthritis who previously had an inadequate response to, or were intolerant of, at least one cDMARD and had not received a biologic disease-modifying antirheumatic drug (bDMARD). Patients received either one of two doses of once-daily baricitinib or placebo, in addition to their background therapy. In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. There were no opportunistic infections or gastrointestinal perforations in the study. A single case of tuberculosis was reported in a patient receiving baricitinib. The most common adverse events observed were consistent with previous studies of baricitinib in RA. Discontinuation rates due to adverse events were similar between treatment groups. A large majority of patients completing this 6-month trial opted to participate in a long-term extension study. Lilly and Incyte announced top-line results from the first Phase 3 trial of baricitinib, RA-BEACON, which alsomet its primary endpoint, in December 2014 and plan to present detailed data from both RA-BEACON and RA-BUILD at scientific meetings in 2015.

Eli Lilly and Co. and Incyte Corp. Announce Second Consecutive Phase 3 Trial in Rheumatoid Arthritis

Eli Lilly and Co. (LLY) and Incyte Corp. (INCY) announced that the investigational medicine baricitinib showed a statistically significant improvement compared to placebo in a second consecutive Phase 3 trial in rheumatoid arthritis or RA. The RA-BUILD study included patients with moderately-to-severely active rheumatoid arthritis who had an inadequate response to, or were intolerant of, at least one conventional disease-modifying antirheumatic drug or cDMARD. The study achieved its primary endpoint of an improved ACR20 response rate compared to placebo after 12 weeks of treatment. According to the company, part of an extensive Phase 3 program testing baricitinib in over 3,000 patients at different stages along the RA treatment continuum, the RA-BUILD study enrolled 684 patients with rheumatoid arthritis who previously had an inadequate response to, or were intolerant of, at least one cDMARD and had not received a biologic disease-modifying antirheumatic drug or bDMARD. Patients received either one of two doses of once-daily baricitinib or placebo, in addition to their background therapy. In RA-BUILD, the incidence of treatment-emergent adverse events and serious adverse events with baricitinib treatment, including serious infections, was similar to placebo. Lilly and Incyte reported top-line results from the first Phase 3 trial of baricitinib, RA-BEACON, which also met its primary endpoint, in December 2014 and plan to present detailed data from both RA-BEACON and RA-BUILD at scientific meetings in 2015.

Incyte Corporation Presents at SunTrust Robinson Humphrey Biotechnology and Pharmaceutical One-on-One Orphan Drug Day, Feb-23-2015

Incyte Corporation Presents at SunTrust Robinson Humphrey Biotechnology and Pharmaceutical One-on-One Orphan Drug Day, Feb-23-2015 . Venue: JW Marriott Essex House, 160 Central Park South, b/w 6th & 7th Avenue, New York, New York, United States.

Incyte Corporation Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2014; Provides Earnings Guidance for the Full Year of 2015

Incyte Corporation reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2014. For the quarter ended December 31, 2014, total revenues were $124 million as compared to $97 million for the same period in 2013. Net loss for the quarter ended December 31, 2014, was $37 million, or $0.22 per basic and diluted share, as compared to a net loss of $43 million, or $0.26 per basic and diluted share, for the same period in 2013. Loss from operations was $25,624,000 compared to $16,143,000 a year ago. Loss before income taxes was $37,200,000 compared to $42,733,000 a year ago. For the full year ended December 31, 2014, total revenues were $511 million as compared to $355 million for the same period in 2013. Net loss for the full year ended December 31, 2014, was $48 million, or $0.29 per basic and diluted share, as compared to a net loss of $83 million, or $0.56 per basic and diluted share, for the same period in 2013. Loss from operations was $4,804,000 compared to $16,102,000 a year ago. Loss before income taxes was $48,547,000 compared to $82,848,000 a year ago. Included in the net loss in 2013 was $11 million in debt exchange expense for senior note conversions related to separately negotiated agreements with certain holders of the 2015 Notes, and a $18 million one-time charge related to the repurchase of $117 million face amount of the 2015 Notes. The company provided earnings guidance for the full year of 2015. The Company expects that Jakafi net product revenues will be in the range of $525 million to $565 million. This amount excludes any product royalty revenues received from Novartis on sales of Jakavi. The Company expects that research and development expenses will be in the range of $450 million to $500 million, including a non-cash expense of approximately $40 million to $45 million related to the impact of expensing employee equity awards. The expected increase in research and development is primarily related to the company's broad investment in the clinical portfolio, including the advancement of ruxolitinib and the company's lead JAK1 inhibitor, INCB39110, in solid tumors, the development of the company's IDO1 inhibitor, epacadostat, in multiple oncologic indications in combination with checkpoint inhibitors as well as costs related to the pending Agenus alliance. The company expects interest expense this year to be $49 million, including a noncash charge of $36 million related primarily to the amortization of the discount on convertible senior notes.

 

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