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Genmab A/S (GEN.CO)

GEN.CO on Copenhagen Stock Exchange

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27 Mar 2017
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Latest Key Developments (Source: Significant Developments)

EMA recommends approval of Daiichi Sankyo's anticoagulant
Friday, 24 Feb 2017 07:00am EST 

EU Medicines Agency: EU medicines Agency recommendations for February 2017 . EU Medicines Agency recommends approval Of Daiichi Sankyo's anticoagulant Edoxaban . EU Medicines Agency says adopted positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product Darzalex . EU Medicines Agency recommends approval of Hospira UK Limited's Pemetrexed for treatment of non-small cell lung cancer Source (http://bit.ly/2lCHPks) Further company coverage: [4568.T] ((Bangalore.newsroom@thomsonreuters.com;)).  Full Article

Genmab FY operating income up to DKK 1,053 million
Wednesday, 22 Feb 2017 11:01am EST 

Genmab A/S : Revenue was 1,816 million Danish crowns ($257.45 million) in 2016 compared to 1,133 million crowns in 2015 . Operating income was 1,053 million crowns in 2016 compared to 730 million crowns in 2015 . Sees 2017 revenue of 1,950 million crowns - 2,150 million crowns . Sees 2017 operating income of 900 million - 1,100 million crowns .Projected revenue for 2017 consists primarily of DARZALEX royalties of 930 million – 1,100 million crowns that are based on an estimated $1,100 million – $1,300 million of DARZALEX net sales in 2017 and DARZALEX milestones of 800 million crowns.  Full Article

Genmab raises 2016 financial guidance
Monday, 6 Feb 2017 12:39am EST 

Genmab A/S : Raises its 2016 financial guidance published on Dec. 20, 2016 . Expects FY revenue of 1.79 billion Danish crowns - 1.84 billion Danish crowns ($259.43 million-$266.67 million) against previous guidance of 1.72 billion-1.77 billion crowns . Expects FY operating income of 1.02 billion crowns - 1.07 billion crowns against previous guidance of 895 million-945 million crowns .Says revenue range increased primarily due to higher royalties on net sales of DARZALEX by Janssen and achievement of additional DuoBody milestones.  Full Article

Genmab: net sales of Darzalex in 2016 $572 million
Tuesday, 24 Jan 2017 06:52am EST 

Genmab A/S : Net sales of Darzalex in 2016 totaled $572 million .Genmab will receive royalties on worldwide sales from Janssen Biotech, Inc..  Full Article

Genmab submits Daratumumab to Japan regulators, lifts 2016 income guidance
Tuesday, 20 Dec 2016 01:05am EST 

Danish pharmaceutical company Genmab says: Regulatory application submitted in Japan for daratumumab for relapsed or refractory multiple myeloma . Submission based on data from SIRIUS, CASTOR and POLLUX studies . To receive $10 million in milestone payments from Janssen - financial guidance updated .Now sees 2016 operating income at 895-945 million DKK versus previous guidance of 825-875 million DKK.  Full Article

Genmab announces U.S. FDA approval of Darzalex (Daratumumab) for relapsed multiple myeloma
Monday, 21 Nov 2016 03:46pm EST 

Genmab A/S : Genmab announces U.S. FDA approval of Darzalex (Daratumumab) for relapsed multiple myeloma and updates financial guidance . Genmab will receive milestone payments totaling $65 million from Janssen . Genmab says anticipate that 2016 operating expenses will remain in range of DKK 800 - 850 million . We expect 2016 revenue to be in range of DKK 1,650 million - 1,700 million, an increase of DKK 450 million compared to previous guidance . Genmab says now expect operating income for 2016 to be approximately DKK 825 - 875 million .Expect FY 2016 Darzalex royalties to remain in range of DKK 400 million - 450 million.  Full Article

Genmab says combination of drugs from J&J, Amgen will be tested in study
Thursday, 10 Nov 2016 08:27am EST 

Genmab : Genmab announces phase III study of daratumumab in combination with carfilzomib in multiple myeloma . Genmab - new phase III study combining daratumumab, carfilzomib,dexamethasone in relapsed/refractory multiple myeloma - dosing expected in 2017 . Genmab - first study under clinical trial collaboration and supply agreement between janssen and amgen .Phase iii study of daratumumab is anticipated to start dosing patients in 2017 and will be sponsored by amgen.  Full Article

Genmab says U.S. FDA grants priority review for daratumumab in relapsed multiple myeloma
Friday, 7 Oct 2016 06:07pm EDT 

Genmab : u.s. Fda grants priority review for daratumumab in relapsed multiple myeloma . Sbla was submitted by genmab's licensing partner, janssen biotech, inc. In august 2016 . Pdufa date set at june 17, 2017 . Fda has assigned pdufa target date of february 17, 2017 to take a decision on daratumumab . Fda has assigned a prescription drug user fee act (pdufa) target date of february 17, 2017 . Sbla submission also included data from phase i study of daratumumab in combination with pomalidomide and dexamethasone .Pdufa date for combination of daratumumab with pomalidomide/dexamethasone is june 17, 2017.  Full Article

Genmab: FDA approves Arzerra for treatment of relapsed chronic lymphocytic leukemia
Wednesday, 31 Aug 2016 05:09am EDT 

Genmab A/S :FDA approved a supplemental biologics license application for use of ofatumumab ((Arzerra) in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed chronic lymphocytic leukemia.  Full Article

Genmab: European Regulatory submission for Daratumumab in Relapsed Multiple Myeloma
Tuesday, 23 Aug 2016 06:52am EDT 

Genmab A/S : Janssen Pharmaceutica NV has submitted a variation to the Marketing Authorization to the European Medicines Agency (EMA) seeking to broaden the existing marketing authorization for daratumumab (DARZALEX) to include treatment of adult patients with multiple myeloma who have received at least one prior therapy . The submission of the application triggers milestone payments totaling $10 million to Genmab from Janssen .In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.  Full Article

More From Around the Web

BRIEF-Genmab: CHMP issues positive opinion recommending DARZALEX (daratumumab)

* CHMP issued positive opinion for DARZALEX for relapsed or refractory multiple myeloma