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Incyte Corp (INCY.O)

INCY.O on Nasdaq

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Latest Key Developments (Source: Significant Developments)

Concert Pharma Says PTAB denies Incyte petition challenging CTP-543 patent
Thursday, 19 Oct 2017 01:00pm EDT 

Oct 19 (Reuters) - Concert Pharmaceuticals Inc ::Concert Pharma says patent trials and appeal board of u.s. patent and trademark office has denied Incyte's petition to institute IPR​.  Full Article

Incyte announces pricing of public offering of 4,945,000 shares
Friday, 8 Sep 2017 08:35am EDT 

Sept 8 (Reuters) - Incyte Corp :Incyte announces pricing of public offering of 4,945,000 shares of common stock.  Full Article

Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018
Wednesday, 30 Aug 2017 06:45am EDT 

Aug 30 (Reuters) - Incyte Corp :Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018.Eli lilly and Co - ‍resubmission package will include new safety and efficacy data​.Eli Lilly and Co - Phase 3 program for psoriatic arthritis is expected to begin in 2018.Eli Lilly says ‍companies anticipate FDA will classify application as a Class II resubmission, which will start a new six-month review cycle​.  Full Article

Incyte Q2 loss per share $0.06
Tuesday, 1 Aug 2017 07:00am EDT 

Aug 1 (Reuters) - Incyte Corp :Incyte reports 2017 second-quarter financial results and updates on key clinical programs.Q2 revenue $326 million versus i/b/e/s view $315.2 million.Q2 loss per share $0.06.Q2 earnings per share view $-0.03 -- Thomson Reuters I/B/E/S.Has updated its full year 2017 financial guidance.Incyte corp - now sees fy 2017 jakafi net product revenue $1,090 to $1,120 million versus prior view of $1,020 to $1,070 million.Fy 2017 iclusig net product revenue outlook unchanged at $60 million to $65 million.  Full Article

Lilly and Incyte provide update on baricitinib
Tuesday, 25 Jul 2017 06:15am EDT 

July 25 (Reuters) - Incyte Corp :Incyte Corp - ‍length of time to a resubmission for New Drug Application(NDA) anticipated to be a minimum of 18 months​.Incyte Corp - ‍FDA has indicated that a new clinical study is necessary for a resubmission in order to further characterize benefit/risk across doses​.Says ‍resubmission to FDA for NDA for baricitinib will be delayed beyond 2017​.Incyte Corp - ‍request for an additional clinical study does not impact ongoing clinical trials for baricitinib​.‍Christi Shaw, president of Lilly Bio-Medicines, says "We are disappointed that resubmission will not occur this year"​.Incyte - Lilly's Christi Shaw says ‍disagree with FDA's conclusions, believe existing data demonstrates positive profile supporting baricitinib approval.  Full Article

Incyte says first patient treated in Phase 3 clinical trial of itacitinib
Thursday, 20 Jul 2017 07:30am EDT 

July 20 (Reuters) - Incyte Corp :Incyte announces first patient treated in Phase 3 clinical trial of itacitinib for acute graft-versus-host disease.Incyte- Trial to evaluate efficacy, safety of itacitinib, in combination with corticosteroids versus placebo plus corticosteroids in patients with acute gvhd​.  Full Article

Incyte says Japan Ministry of Health, Labor And Welfare grants marketing approval for Olumiant
Monday, 3 Jul 2017 08:00am EDT 

July 3 (Reuters) - Incyte Corp :Japan ministry of health, labor and welfare (mhlw) grants marketing approval for olumiant® (baricitinib) for the treatment of rheumatoid arthritis.Incyte- ‍japan marketing authorization of olumiant triggers $15 million milestone payment from lilly to co, which co expects to recognize, in full,in q3 2017​.  Full Article

Incyte says epacadostat, Bristol-Myers' Opdivo combo data positive in head and neck cancer patients
Monday, 5 Jun 2017 07:30am EDT 

June 5 (Reuters) - Incyte Corp :Clinical trial data for combination of epacadostat and opdivo® (nivolumab) demonstrate durable clinical responses in patients with melanoma and head and neck cancer.Incyte corp - combination of ido1 enzyme inhibition plus opdivo was generally well-tolerated in patients with select advanced solid tumors.  Full Article

Incyte Corp updates on Echo-202 trial of Incyte’s Epacadostat in combination with Merck’s Keytruda
Monday, 5 Jun 2017 07:00am EDT 

June 5 (Reuters) - Incyte Corp ::Updated data from Echo-202 trial of Incyte’s Epacadostat in combination with Merck’s Keytruda® (Pembrolizumab) demonstrate clinical activity across multiple tumor types.‍responses observed with combination of Ido1 enzyme inhibition and Anti-Pd-1 therapy support advancing into Broad Phase 3 program​.‍safety data for this novel investigational immunotherapy combination are generally similar to Keytruda monotherapy​.  Full Article

U.S. FDA issues CRL for baricitinib
Friday, 14 Apr 2017 09:00am EDT 

Incyte Corp : U.S. FDA issues complete response letter for baricitinib . Letter indicates that FDA is unable to approve application in its current form . Specifically, FDA indicated that additional clinical data are needed to determine most appropriate doses . FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms . "Companies disagree with agency's conclusions" . Incyte is evaluating impact of complete response on its previously-issued milestone and research and development expense guidance for 2017 .Lilly is reaffirming both its financial guidance for 2017 and its mid-term guidance for remainder of this decade.  Full Article

BRIEF-Concert Pharma Says PTAB denies Incyte petition challenging CTP-543 patent

* Concert Pharma says patent trials and appeal board of u.s. patent and trademark office has denied Incyte's petition to institute IPR​ Source text for Eikon: Further company coverage: