Key Developments: Merck & Co Inc (MRK)

MRK on New York Consolidated

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18 Sep 2014
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Latest Key Developments (Source: Significant Developments)

Sun Pharmaceutical Industries Ltd and Merck & Co. Inc. enter into licensing agreement for Tildrakizumab
Wednesday, 17 Sep 2014 08:30am EDT 

Sun Pharmaceutical Industries Ltd and Merck & Co. Inc:Says through their respective subsidiaries, announced an exclusive worldwide licensing agreement for Merck's investigational therapeutic antibody candidate, tildrakizumab.Under terms, Sun Pharma will acquire worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of US$80 mln.Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma.Transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.  Full Article

Merck & Co Inc receives accelerated approval of Keytruda (pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
Thursday, 4 Sep 2014 03:15pm EDT 

Merck & Co Inc:Announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA(pembrolizumab) at a dose of 2 mg/kg every three weeks.For the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.This indication is approved under accelerated approval based on tumor response rate and durability of response.An improvement in survival or disease-related symptoms has not yet been established.Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.KEYTRUDA is the first anti-PD-1 (programmed death receptor-1) therapy approved in the United States and received FDA's Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need.  Full Article

FDA approves Merck & Co Inc's BELSOMRA (suvorexant) for the treatment of insomnia
Wednesday, 13 Aug 2014 04:49pm EDT 

Merck & Co Inc:Announced that the U.S. Food and Drug Administration (FDA) has approved BELSOMRA (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep.BELSOMRA (pronounced bell-SOM-rah) is a selective antagonist for orexin receptors.Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake.FDA has recommended BELSOMRA be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled product.  Full Article

Merck & Co Inc completes tender offer to acquire Idenix Pharmaceuticals Inc
Tuesday, 5 Aug 2014 06:00am EDT 

Merck & Co Inc:Completion of tender offer for all of outstanding shares of common stock of Idenix Pharmaceuticals Inc. at purchase price of $24.50 per share.As of tender offer representing about 82.5 pct of outstanding common stock of Idenix on fully diluted basis.All of such shares have been accepted for payment in accordance with the terms of tender offer, and Merck expects to promptly pay for all such shares.Following consummation of tender offer, Merck expects to complete acquisition of Idenix later through merger of Merck's wholly-owned subsidiary with and into Idenix without stockholder approval.  Full Article

Merck & Co Inc reaffirms FY 2014 revenue guidance; raises low end of prior FY 2014 EPS guidance to a range in line with analysts' estimates
Tuesday, 29 Jul 2014 06:56am EDT 

Merck & Co Inc:Expects FY 2014 non-GAAP EPS to be between $3.43 and $3.53, which excludes the potential impact of a Venezuelan Bolivar devaluation that was previously included in the range.Expects FY 2014 GAAP EPS to be between $4.44 and $4.77.Continues to expect FY 2014 revenues to be between $42.4 billion and $43.2 billion.FY 2014 EPS of $3.48 and revenue of $42.6 bln - Thomson Reuters I/B/E/S.  Full Article

Merck initiates phase 3 study of Letermovir
Thursday, 24 Jul 2014 08:30am EDT 

Merck Inc:Announces that the first patient has been enrolled in a global Phase 3 clinical study of letermovir (MK-8228), an investigational antiviral agent.Multicenter, randomized, placebo-controlled study will evaluate the efficacy and safety of letermovir for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of allogeneic hematopoietic stem cell transplants.  Full Article

Merck & Co Inc declares quarterly dividend
Wednesday, 23 Jul 2014 12:15pm EDT 

Merck & Co Inc:Declares quarterly dividend of $0.44 per share of the company's common stock for the fourth quarter of 2014.Payment will be made on Oct. 7, to stockholders of record at the close of business on Sept. 15.  Full Article

Kyorin Holdings Inc subsidiary signs license agreement with Merck on Vibegron for Overactive Bladder in Japan
Tuesday, 22 Jul 2014 02:00am EDT 

Kyorin Holdings Inc:Subsidiary KYORIN Pharmaceutical signed license agreement with Merck on Vibegron for Overactive Bladder in Japan.Merck granted to Kyorin an exclusive license to develop, manufacture and commercialize Vibegron in Japan and Kyorin will make an upfront payment and additional contingent milestone payments to Merck, including royalties on product sales.  Full Article

SANTEN PHARMACEUTICAL CO LTD announces completes asset purchase agreement with respect to acquisition of ophthalmology assets from Merck
Wednesday, 2 Jul 2014 02:00am EDT 

SANTEN PHARMACEUTICAL CO LTD:Completed acquire certain ophthalmology assets from Merck & Co., Inc. on July 2.Santen's payment for the closed transaction totaled approximately $550 million (approximately 56 billion yen).Says details disclosed on May 13.  Full Article

Merck & Co Inc announces data from investigational phase 3 study on EMEND
Monday, 30 Jun 2014 08:00am EDT 

Merck & Co Inc:Results from global, investigational Phase 3 study to evaluate the safety and efficacy of EMEND (aprepitant) in prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.In this study in pediatric cancer patients undergoing very highly, highly, or moderately emetogenic (vomit-inducing) chemotherapy.Says use of EMEND regimen for CINV prevention was significantly more effective than control regimen in achieving Complete Response, defined as no vomiting or retching and no use of rescue medication for nausea and vomiting, in all phases of CINV (acute, delayed, and overall).Nausea and vomiting are common complications of cancer chemotherapy and can be particularly distressful and debilitating to pediatric cancer patients.Based on these data, Merck plans worldwide regulatory submissions for EMEND (aprepitant), beginning in the United States, for use in the prevention of CINV in pediatric and adolescent cancer patients (ages 6 months to 17 years).In the United States, Merck plans to submit a New Drug Application (NDA) for a new pediatric formulation (powder for suspension) and a supplemental NDA for use of the current formulation (capsules).Both filings are planned for the second half of 2014.  Full Article

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