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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

Biothera Pharmaceuticals expands relationship with Merck
Wednesday, 24 Aug 2016 11:25am EDT 

Merck & Co Inc :Biothera pharmaceuticals expands relationship with Merck, enters collaboration for combination cancer immunotherapy trials in multiple indications.  Full Article

BRIEF-Merck & Co says FDA approves Keytruda for a type of head and neck cancer (Aug 5)
Monday, 8 Aug 2016 11:43am EDT 

Corrects headline to say the FDA approved Keytruda for a type of head and neck cancer. The drug is already approved for other types of cancers.Merck & Co Inc : Based on its mechanism of action, Keytruda can cause fetal harm when administered to a pregnant woman . Continued approval for indication for Keytruda may be contingent upon verification, description of clinical benefit in confirmatory trials . FDA approves Merck's Keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy . Immune-mediated adverse reactions occurred with keytruda including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis .Under FDA's accelerated approval regulations, this indication for keytruda approved based on tumor response rate, durability of response.  Full Article

Merck & Co says FDA approves keytruda
Friday, 5 Aug 2016 07:30pm EDT 

Merck & Co Inc : Based on its mechanism of action, keytruda can cause fetal harm when administered to a pregnant woman . Continued approval for indication for keytruda may be contingent upon verification, description of clinical benefit in confirmatory trials . FDA approves Merck's keytruda (pembrolizumab) for patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy . Immune-mediated adverse reactions occurred with keytruda including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis .Under FDA's accelerated approval regulations, this indication for keytruda approved based on tumor response rate, durability of response.  Full Article

Merck announces U.S. FDA filing acceptance of new drug application (NDA) for mk-1293
Friday, 5 Aug 2016 08:00am EDT 

Merck Announces U.S. FDA Filing Acceptance Of New Drug Application (NDA) For Mk : 1293, an investigational follow-on biologic insulin Glargine . Merck announces U.S. FDA filing acceptance of new drug application (NDA) for mk-1293, an investigational follow-on biologic insulin Glargine .Marketing authorization application to European medicines agency currently under review.  Full Article

Biogen has drawn takeover interest from drug companies including Merck & Co and Allergan - WSJ
Tuesday, 2 Aug 2016 02:47pm EDT 

: Biogen has drawn takeover interest from drug companies including Merck & Co and Allergan Plc- WSJ, citing sources Source (http://on.wsj.com/2b0s6q9) (Bengaluru Newsroom: +1-646-223-8780).  Full Article

Merck Q2 adjusted earnings per share $0.93
Friday, 29 Jul 2016 06:45am EDT 

Merck Announces Second : Q2 januvia/janumet sales $ 1,634 million versus $1,412 million in q1 . Second-Quarter pharmaceutical sales increased 2 percent to $8.7 billion . Raised bottom end of its full-year 2016 non-gaap eps range . Full-Year 2016 gaap eps range reflects impact of intangible asset impairment charges and higher restructuring costs incurred in q2 . Fy2016 earnings per share view $3.72, revenue view $39.49 billion -- Thomson Reuters I/B/E/S . Merck & co inc qtrly keytruda total sales $314 million versus $110 million . Fy 2016 revenue outlook includes an approximately 2 percent negative impact from foreign exchange at current exchange rates . Quarter 2016 financial results . Q2 non-gaap earnings per share $0.93 . Q2 gaap earnings per share $0.43 . Q2 sales $9.8 billion versus i/b/e/s view $9.78 billion . Q2 earnings per share view $0.91 -- Thomson Reuters I/B/E/S . Sees fy 2016 non-gaap earnings per share $3.67 to $3.77 . Sees fy 2016 gaap earnings per share $1.98 to $2.08 . Q2 remicade sales $339 million versus $455 million . Merck has narrowed its full-year 2016 revenue range to be between $39.1 billion and $40.1 billion . Lowered its full-year 2016 gaap eps range .As of june 30, 2016, merck had approximately 68,000 employees worldwide.  Full Article

Merck plans to end partnership agreement with Alk Abello
Wednesday, 27 Jul 2016 01:25am EDT 

Alk Abello A/S : Said on Tuesday MSD (known as Merck in the United States and Canada) had informed ALK of its plans to end their partnership agreement . Said all rights to GRASTEK, RAGWITEK and investigational house dust mite SLIT-tablets for USA, Canada and Mexico to revert to ALK at no fee following six- month transition period . Ongoing registration processes for investigational HDM SLIT-tablet will continue . North America remains major business opportunity and ALK will now undertake full strategic analysis before deciding on revised strategy . Transaction has no impact on ALK's full-year outlook for 2016 .Acting CEO and Chairman Steen Riisgaard said: "The timing of this move is unexpected".  Full Article

Merck sets quarterly dividend of $0.46 per share
Tuesday, 26 Jul 2016 12:50pm EDT 

Merck & Co Inc :Sets quarterly dividend of $0.46 per share.  Full Article

Enigma biomedical announces research collaboration agreement with Biogen Inc and Merck
Monday, 25 Jul 2016 05:04pm EDT 

Enigma Biomedical Group Inc: Collaboration focused on qualification and validation of Tau imaging agent developed by Merck, MK-6240 .Announced a research collaboration agreement with Biogen Inc and Merck.  Full Article

Merck designated breakthrough therapy by FDA and gets prime status from EMA for ebola vaccine
Monday, 25 Jul 2016 08:00am EDT 

Merck & Co Inc : Merck is responsible for research, development, manufacturing, and regulatory efforts in support of v920 .Merck receives breakthrough therapy designation from fda and prime status from ema for investigational ebola zaire vaccine (v920).  Full Article

Judge invalidates Merck's NuvaRing patent claims

A federal judge in Delaware has struck down Merck & Co's patent infringement claims against Actavis' Warner Chilcott unit, which is seeking to sell a generic version of the NuvaRing contraceptive.