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Incyte Corp (INCY.OQ)

INCY.OQ on NASDAQ Stock Exchange Global Select Market

134.38USD
26 May 2017
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Latest Key Developments (Source: Significant Developments)

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

Incyte to replace Spectra Energy in S&P 500
Thursday, 23 Feb 2017 05:57pm EST 

: S&P Dow Jones Indices - Incyte will replace Spectra Energy in the S&P 500 effective at the open of trading on February 28 .S&P Dow Jones Indices - CBOE Holdings will replace Pitney Bowes in the S&P 500.  Full Article

Incyte Corp says entered into letter agreement with certain entities affiliated with Julian Baker - SEC filing
Tuesday, 21 Feb 2017 08:37am EST 

Incyte Corp : Incyte Corp- entered into a letter agreement, dated February 17, 2017 with certain entities affiliated with Julian Baker - SEC filing . Incyte Corp - pursuant to agreement, baker entities agreed to exchange $259 million co's 0.375 pct notes due 2018,$274.5 million co's 1.25 pct notes due 2020 .Incyte Corp - agreement in exchange for an aggregate of 10.6 million shares of company's common stock, $.001 par value per share - SEC filing.  Full Article

Incyte reports Q4 earnings per share $0.05
Tuesday, 14 Feb 2017 07:00am EST 

Incyte Corp : Incyte reports 2016 fourth-quarter and year-end financial results, provides 2017 financial guidance and updates on key clinical programs . Q4 revenue $326 million versus I/B/E/S view $324.4 million . Q4 earnings per share $0.05 . Q4 earnings per share view $0.13 -- Thomson Reuters I/B/E/S . Sees 2017 Jakafi net product revenues $1,020-$1,070 million . Sees 2017 ongoing research and development expenses $785-$835 million . Sees 2017 change in fair value of acquisition-related contingent consideration $30-$35 million . Incyte Corp - pivotal program of ruxolitinib as a treatment for patients with essential thrombocythemia is also expected to begin in 2017 .Incyte - phase 3 trials in steroid-refractory acute, steroid-refractory chronic gvhd, respectively, expected to begin in 2017 with novartis.  Full Article

Immunovaccine says Princess Margaret Cancer Centre to conduct Phase 2 clinical trial to evaluate use of co, Merck's combination of immunotherapies
Monday, 6 Feb 2017 07:05am EST 

Immunovaccine Inc : Immunovaccine's lead immuno-oncology candidate to enter investigator-sponsored Phase 2 clinical trial in ovarian cancer in combination with approved anti-PD-1 drug . Princess Margaret Cancer Centre to conduct Phase 2 clinical trial to evaluate use of combination of immunotherapies from co and Merck . Expects to announce top-line interim results for Phase 1B trial of DPX-Survivac by end of March 2017 .In addition to Phase 2 trial, Immunovaccine is conducting a phase 1B trial with Incyte Corporation.  Full Article

U.S. FDA extends review period for Baricitinib, an investigational rheumatoid arthritis treatment
Friday, 13 Jan 2017 04:51pm EST 

Incyte Corp : U.S. FDA extends review period for baricitinib, an investigational rheumatoid arthritis treatment . Incyte Corp says delay does not affect Lilly's previously-issued financial guidance for 2017 . Incyte - FDA extended action date to allow time to review additional data analyses recently submitted by Lilly in response to FDA's information requests .Incyte- Submission of additional information was determined by FDA to constitute major amendment to NDA, resulting in extension of PDUFA date by 3 months.  Full Article

Incyte and Merus announce global strategic research collaboration
Wednesday, 21 Dec 2016 07:00am EST 

Incyte Corp : Incyte and Merus announce global strategic research collaboration to discover and develop bispecific antibodies . Incyte to make up-front payment of $120 million and purchase $80 million of Merus common shares . Merus eligible to receive potential development, regulatory and commercial milestones and sales royalties . Parties have agreed to collaborate on development and commercialization of up to 11 bispecific antibody programs . Merus will retain all rights to develop and commercialize approved products in united states . Merus also has option to co-fund development of product candidates arising from two other programs . Incyte - for eight programs merus to be eligible to get potential development, regulatory and sales milestone payments of up to $350 million per program . Incyte will develop and commercialize approved products arising from program outside united states . For eight programs Incyte has agreed to independently fund all development and commercialization activities .Merus also eligible to receive tiered royalties ranging from 6 to 10 percent on global sales of approved products under 8 programs.  Full Article

Incyte reported Q2 EPS $0.18
Tuesday, 9 Aug 2016 07:00am EDT 

Incyte Corp : Quarter financial results and updates key clinical programs . Q2 earnings per share $0.18 . Q2 earnings per share view $-0.02 -- Thomson Reuters I/B/E/S . Q2 revenue $246 million versus I/B/E/S view $234.5 million .Sees 2016 Jakafi net product revenue $825 mln - $835 million.  Full Article

Agenus Inc starts phase 1/2 clinical trial of anti-GITR agonist antibody
Wednesday, 22 Jun 2016 08:50am EDT 

Agenus Inc : Expect to initiate additional clinical studies with antibodies and immuno-oncology leads from comprehensive pipeline in next twelve months .Agenus announces commencement of phase 1/2 clinical trial of anti-GITR checkpoint antibody INCAGN1876 in patients with solid tumors.  Full Article

Incyte announces phase 3 data of Jakafi study
Friday, 10 Jun 2016 02:35am EDT 

Incyte Corp : Says announced new 28-week data from phase 3 response-2 study of Jakafi . Says data show that Jakafi was superior to best available therapy in maintaining hematocrit control . Says safety profile of Jakafi was consistent with previous studies . Study shows that nearly five times more patients with pv achieved complete hematologic remission with Jakafi compared to bat at 28 weeks . Says overall, Jakafi was well tolerated . Says findings from this study are consistent with data from response pivotal trial .New phase 3 data show Jakafi (ruxolitinib) is superior to best available therapy in patients with polycythemia vera.  Full Article

More From Around the Web

Merck, Incyte immunotherapy combination effective in lung cancer study

A combination of the Merck & Co immunotherapy Keytruda and a different type of drug that also helps the immune system fight cancer from Incyte Corp led to a high rate of durable responses in a small, ongoing study of patients with advanced lung cancer, according to data released on Wednesday.