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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

FDA grants priority review to Merck's supplemental marketing application for Keytruda
6:55am EDT 

May 23 (Reuters) - Merck & Co Inc -:FDA grants priority review to Merck’S supplemental biologics license application (sbla) for Keytruda® (pembrolizumab) for treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma.Merck & Co Inc - fda granted priority review with a pdufa, or target action, date of sept. 22, 2017.Merck & Co -application submitted seeks approval for keytruda monotherapy in previously treated patients at 200 mg dose administered intravenously every 3 weeks.  Full Article

Merck announces presentation of phase 2 results for MK-7264
Monday, 22 May 2017 11:20am EDT 

May 22 (Reuters) - Merck & Co Inc :Merck announces presentation of phase 2 results for MK-7264, an investigational, p2x3 receptor antagonist, being evaluated for the treatment of chronic cough.Highest dose evaluated, 50 mg, reduced awake cough frequency primary endpoint, by 37 percent from baseline relative to placebo.Lower doses (7.5 mg and 20 mg) were not statistically significant.Merck plans to discuss results and phase 3 clinical development plan for MK-7264 with regulatory agencies later this year.One patient in placebo group and six patients in 50 mg treatment group discontinued due to taste-related adverse events.  Full Article

Merck receives CHMP positive opinion recommending approval of isentress
Friday, 19 May 2017 08:00am EDT 

May 19 (Reuters) - Merck & Co Inc ::Merck receives chmp positive opinion recommending approval of isentress® (raltegravir) 600 mg in the european union.Merck receives chmp positive opinion recommending approval of isentress® (raltegravir) 600 mg in the european union.Merck & Co Inc - decision on approval is expected in second half of 2017.Says a decision on approval is expected in second half of 2017.Merck & Co Inc - once daily formulation of isentress is currently under review in united states by food and drug administration.  Full Article

Aduro Biotech announces clinical collaboration with Merck
Wednesday, 17 May 2017 09:05am EDT 

May 17 (Reuters) - Aduro Biotech Inc ::Aduro Biotech announces clinical collaboration with Merck to evaluate combination of Aduro's CRS-207 with Merck's Keytruda for treatment of Mesothelioma.Says announced expansion of clinical collaboration with Merck to include additional Phase 2 clinical trial.  Full Article

Syndax Pharmaceuticals announces advancement of encore 601
Tuesday, 16 May 2017 05:26pm EDT 

May 16 (Reuters) - Syndax Pharmaceuticals Inc ::Syndax Pharmaceuticals announces advancement of encore 601 in non-small cell lung cancer patients with disease progression on or after PD-1 therapies.Syndax Pharmaceuticals Inc - cohort of NSCLC patients who had previously progressed on PD-1 or PD-l1 will now re-open and enroll a total of 56 patients.Syndax Pharmaceuticals Inc- completion of enrollment is anticipated in first half of 2018 for study.Syndax Pharmaceuticals - later this quarter, co anticipates being able to determine whether to expand cohort of NSCLC patients naïve to PD-1 or PD-l1 therapy.Syndax-Encore 601 non-small cell lung cancer study has met pre-specified objective response threshold to advance into 2nd stage of phase 2 trial.  Full Article

U.S. FDA approves Merck's Keytruda chemo combo for lung cancer
Wednesday, 10 May 2017 05:39pm EDT 

May 10 (Reuters) - Merck & Co Inc :Fda approves Merck's Keytruda® (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-l1 expression.Merck & Co Inc - Under FDA's accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival.  Full Article

European Commission grants approval for Merck's new Pergoveris Pen for fertility treatment
Wednesday, 10 May 2017 10:01am EDT 

May 10 (Reuters) - Merck & Co Inc : :European Commission grants approval for Merck's new Pergoveris® Pen for fertility treatment.European Commission granted approval for Pergoveris pen for women with severe follicle stimulating hormone, luteinizing hormone deficiency.  Full Article

Cerveau Technologies says finalization of a clinical supply agreement with Merck
Thursday, 4 May 2017 11:14am EDT 

May 4 (Reuters) - Cerveau Technologies Inc:Cerveau Technologies Inc. Signs clinical supply agreement with merck for investigational tau imaging agent.Cerveau Technologies says finalization of a clinical supply agreement with merck.Cerveau Technologies- will be responsible for providing access to MK-6240 at multiple sites globally to be used in Merck-specific research initiatives.Cerveau Technologies- will be accelerating technology transfer and site qualification in over 15 sites to provide access to support broad availability.  Full Article

Merck expecting somewhat slower animal health growth
Tuesday, 2 May 2017 09:02am EDT 

May 2 (Reuters) - Merck & Co Inc :Merck & Co says expects growth in animal health to be "more measured" in subsequent quarters.  Full Article

PDL BioPharma announces settlement of Keytruda lawsuit with Merck
Monday, 24 Apr 2017 07:00am EDT 

April 24 (Reuters) - PDL BioPharma Inc ::PDL BioPharma announces settlement of Keytruda patent infringement lawsuit with Merck.PDL BioPharma Inc - under terms of agreement, Merck will pay company a one time, lump-sum payment of $19.5 million.PDL BioPharma Inc - company will grant Merck a fully paid-up, royalty free, non-exclusive license to certain of company's Queen et al.PDL BioPharma Inc - in addition, parties agreed to dismiss all claims in relevant legal proceedings.PDL BioPharma Inc - as a result of settlement, expect to recognize $19.5 million in license revenue for q2 ending june 30, 2017.  Full Article

More From Around the Web

FDA clears Merck's Keytruda based on cancer genetics, not location

Merck & Co's immunotherapy Keytruda on Tuesday became the first cancer drug ever approved by the U.S. Food and Drug Administration based on a patients' specific genetic traits, regardless of where in the body the disease originated.