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Merck & Co Inc (MRK)

MRK on New York Consolidated

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30 Sep 2016
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Latest Key Developments (Source: Significant Developments)

Merck, Pfizer say investigational Ertugliflozin met primary endpoint
Thursday, 15 Sep 2016 08:31am EDT 

Merck & Co Inc : Merck and pfizer announce investigational Ertugliflozin met primary endpoint of A1C reduction when added to Sitagliptin and Metformin in people with type 2 diabetes . Merck and Pfizer plan to submit NDA for ertugliflozin, two fixed-dose combinations (Ertugliflozin plus Januvia and Ertugliflozin plus metformin) by end of 2016 .Additional regulatory submissions outside of to happen in 2017.  Full Article

Merck Canada says BRENZYS approved in Canada
Monday, 12 Sep 2016 08:00am EDT 

Merck Canada Inc:BRENZYS approved in Canada for treatment of adult patients with moderate to severe rheumatoid arthritis and ankylosing spondylitis.  Full Article

Merck says FDA grants breakthrough therapy designation to Keytruda
Wednesday, 7 Sep 2016 06:45am EDT 

Merck & Co Inc : FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck's Keytruda® (pembrolizumab) for first-line treatment of patients with advanced non-small cell lung cancer . Has also submitted a marketing authorization application to European Medicines Agency for Keytruda in same patient population . FDA assigned a PDUFA, or target action, date of Dec. 24, 2016 .Merck filed for approval of Keytruda in first-line setting at a dose of 200 mg every three weeks, dose studied in keynote-024.  Full Article

Merck provides update on odanacatib development program
Friday, 2 Sep 2016 07:00am EDT 

Merck & Co Inc : Merck provides update on odanacatib development program . Discontinuing development of odanacatib . Will not seek regulatory approval for use of odanacatib . To discontinue development after independent adjudication of major adverse cardiovascular events confirmed an increased risk of stroke .Merck & Co Inc says "at same time, believe that increased risk of stroke in our phase 3 trial does not support further development".  Full Article

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

EU mergers and takeovers (Sept 27)

BRUSSELS, Sept 27 The following are mergers under review by the European Commission and a brief guide to the EU merger process: