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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

FDA Accepts Supplemental Biologics License Application For Merck's Keytruda As Adjuvant Therapy In Advanced Melanoma
Monday, 25 Jun 2018 06:30am EDT 

June 25 (Reuters) - Merck & Co Inc ::FDA ACCEPTS SUPPLEMENTAL BIOLOGICS LICENSE APPLICATION FOR MERCK’S KEYTRUDA® (PEMBROLIZUMAB) AS ADJUVANT THERAPY IN ADVANCED MELANOMA.MERCK & CO INC - FDA GRANTED A PRESCRIPTION DRUG USER FEE ACT (PDUFA), OR TARGET ACTION, DATE OF FEBRUARY 16, 2019.  Full Article

Merck And Premier Collaborate To Help Reduce Clostridium Difficile Infection
Thursday, 31 May 2018 08:53am EDT 

May 31 (Reuters) - Merck & Co Inc ::MERCK AND PREMIER INC. COLLABORATING TO HELP REDUCE CLOSTRIDIUM DIFFICILE (C. DIFF) INFECTION.MERCK - FINANCIAL TERMS OF COLLABORATION WERE NOT DISCLOSED.  Full Article

Eisai Says FDA Has Extended Action Date For sNDA For Lenvatinib
Thursday, 24 May 2018 07:34pm EDT 

May 24 (Reuters) - Merck & Co Inc ::EISAI AND MERCK PROVIDE UPDATE ON SUPPLEMENTAL NEW DRUG APPLICATION (SNDA) FOR LENVATINIB IN FIRST-LINE UNRESECTABLE HEPATOCELLULAR CARCINOMA.EISAI - FDA HAS INDICATED THAT EXTENSION OF PRESCRIPTION DRUG USER FEE ACT DATE IS NEEDED TO ALLOW ADDITIONAL TIME FOR REVIEW OF THE APPLICATION.EISAI SAYS FDA HAS EXTENDED ACTION DATE FOR SNDA FOR LENVATINIB FOR POTENTIAL FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA.EISAI - WORKING CLOSELY WITH FDA TO SUPPORT CONTINUED REVIEW OF THE APPLICATION.  Full Article

Merck Sets Quarterly Dividend Of $0.48/Share
Tuesday, 22 May 2018 02:21pm EDT 

May 22 (Reuters) - Merck & Co Inc ::SETS QUARTERLY DIVIDEND OF $0.48 PER SHARE.  Full Article

FDA Issues Alert On Use Of Keytruda/Tecentriq For Patients With Urothelial Cancer, Have Low Expression Of PD-L1
Friday, 18 May 2018 12:19pm EDT 

May 18 (Reuters) - FDA::U.S. FDA - ISSUES ALERT ABOUT DECREASED SURVIVAL ASSOCIATED WITH THE USE OF KEYTRUDA (PEMBROLIZUMAB) OR TECENTRIQ (ATEZOLIZUMAB).U.S. FDA SAYS THERE WAS NO CHANGE IN THE ADVERSE EVENT PROFILE OF KEYTRUDA OR TECENTRIQ.FDA - MERCK, GENENTECH HAVE STOPPED ENROLLING PATIENTS WHOSE TUMORS HAVE PD-L1 LOW STATUS TO KEYTRUDA/TECENTRIQ MONOTHERAPY ARMS PER DMCS’ RECOMMENDATIONS.U.S. FDA SAYS MONOTHERAPY ARMS REMAIN OPEN ONLY TO PATIENTS WHOSE TUMORS HAVE PD-L1 HIGH STATUS.U.S. FDA - COMBINATION ARMS AND THE CHEMOTHERAPY ARMS OF BOTH STUDIES ALSO REMAIN OPEN.FDA - ISSUED ALERT ON KEYTRUDA/TECENTRIQ AS MONOTHERAPY FOR PATIENTS WITH UROTHELIAL CANCER WHO HAVE NOT RECEIVED PRIOR THERAPY, HAVE LOW EXPRESSION OF PD-L1.  Full Article

AstraZeneca Says Lynparza Tablets Receive EU Approval
Tuesday, 8 May 2018 06:00am EDT 

May 8 (Reuters) - AstraZeneca PLC ::EMA APPROVES LYNPARZA: MAINTENANCE OVARIAN CANCER.LYNPARZA TABLETS RECEIVE EU APPROVAL FOR TREATMENT OF PLATINUM-SENSITIVE RELAPSED OVARIAN CANCER.  Full Article

Merck & Co Says U.S. FDA Has Set PDUFA Date Of Sept. 23, 2018
Monday, 30 Apr 2018 06:45am EDT 

April 30 (Reuters) - Merck & Co Inc ::FDA GRANTS PRIORITY REVIEW TO MERCK'S SBLA FOR KEYTRUDA® (PEMBROLIZUMAB) IN COMBINATION WITH PEMETREXED (ALIMTA®) AND PLATINUM CHEMOTHERAPY BASED ON RESULTS FROM PHASE 3 KEYNOTE-189 TRIAL AS FIRST-LINE TREATMENT OF METASTATIC NONSQUAMOUS NSCLC.MERCK & CO INC - U.S. FDA HAS SET A PDUFA DATE OF SEPT. 23, 2018.  Full Article

Merck & Co Inc Files For Potential Debt Shelf Size Not Disclosed
Thursday, 29 Mar 2018 04:50pm EDT 

March 29 (Reuters) - Merck & Co Inc ::MERCK & CO INC FILES FOR POTENTIAL DEBT SHELF; SIZE NOT DISCLOSED - SEC FILING.  Full Article

Tesaro Says TOPACIO Data Demonstrates Compelling Clinical Activity Of Zejula In Patients With Type Of Ovarian Cancer
Monday, 26 Mar 2018 04:00pm EDT 

March 26 (Reuters) - Tesaro Inc ::DATA FROM TOPACIO TRIAL REPORTED AT SGO DEMONSTRATES COMPELLING CLINICAL ACTIVITY OF ZEJULA IN COMBINATION WITH AN ANTI-PD-1 ANTIBODY IN PATIENTS WITH PLATINUM RESISTANT/REFRACTORY OVARIAN CANCER.TESARO INC - ‍EFFICACY OF NIRAPARIB IN COMBINATION WITH AN ANTI-PD-1 MAB SURPASSES HISTORICAL EFFICACY BENCHMARKS FOR PD-1 OR PARP MONOTHERAPIES​.TESARO INC - COMBINATION OF NIRAPARIB WITH PEMBROLIZUMAB WAS WELL TOLERATED WITH AN INCIDENCE OF GRADE 3/4 THROMBOCYTOPENIA OF 9%.TESARO-POTENTIAL APPROACH TO REDUCE INCIDENCE OF GRADE 3 OR 4 THROMBOCYTOPENIA IDENTIFIED BASED ON RETROSPECTIVE ANALYSIS OF DATA FROM PHASE 3 NOVA TRIAL.TESARO - IN ADDITION TO THROMBOCYTOPENIA, OTHER MOST COMMONLY OBSERVED GRADE ≥3 ADVERSE EVENTS N STUDY INCLUDED ANEMIA AND NEUTROPENIA.  Full Article

Merck Announces Second-Quarter 2018 Dividend
Tuesday, 23 Jan 2018 02:47pm EST 

Jan 23 (Reuters) - Merck & Co Inc ::MERCK ANNOUNCES SECOND-QUARTER 2018 DIVIDEND.MERCK & CO INC - ‍BOARD OF DIRECTORS HAS DECLARED A QUARTERLY DIVIDEND OF $0.48 PER SHARE OF COMPANY'S COMMON STOCK FOR Q2 OF 2018​.  Full Article

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U.S. Supreme Court to hear Merck appeal over Fosamax suits

WASHINGTON The U.S. Supreme Court on Thursday agreed to hear Merck & Co's appeal of a lower court's ruling that revived hundreds of lawsuits accusing the company of failing to adequately warn patients of the risks of thigh bone fractures associated with its osteoporosis drug Fosamax.