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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

European Commission Approves Merck's Keytruda As Adjuvant Therapy For Adults With Resected Stage III Melanoma
Monday, 17 Dec 2018 

Dec 17 (Reuters) - Merck & Co Inc ::EUROPEAN COMMISSION APPROVES MERCK’S KEYTRUDA® (PEMBROLIZUMAB) AS ADJUVANT THERAPY FOR ADULTS WITH RESECTED STAGE III MELANOMA.MERCK & CO INC - APPROVAL ALLOWS MARKETING OF KEYTRUDA IN NEW INDICATION IN ALL 28 EU MEMBER STATES PLUS ICELAND, LICHTENSTEIN AND NORWAY.  Full Article

Roche Collaborates With Merck To Develop Companion Diagnostic Test To Identify Patients Eligible For Anti-Pd-1 Therapy
Tuesday, 11 Dec 2018 

Dec 11 (Reuters) - Roche Holding AG ::ROCHE TO DEVELOP COMPANION DIAGNOSTIC TEST TO HELP IDENTIFY PATIENTS ELIGIBLE FOR ANTI-PD-1 THERAPY BASED ON BIOMARKER EXPRESSION, NOT LOCATION, OF SOLID TUMORS.ROCHE HOLDING AG - WILL SEEK FDA APPROVAL FOR BIOMARKER PANEL EXPECTED TO PROVIDE A STANDARDIZED PREDICTIVE TESTING OPTION FOR DMMR.ROCHE HOLDING AG - ENTERED COLLABORATION WITH MERCK TO DEVELOP A COMPANION DIAGNOSTIC TEST TO IDENTIFY PATIENTS ELIGIBLE FOR ANTI-PD-1 THERAPY.ROCHE HOLDING AG - COMPANIES WILL COLLABORATE ON DEVELOPMENT OF A PAN-CANCER COMPANION DIAGNOSTIC.  Full Article

European Commission Approves Merck's Delstrigo, A Once-Daily Fixed-Dose Combination Tablet As A Complete Regimen And Pifeltro, An NNRTI, Both For Treatment Of HIV-1 In Appropriate Patients
Wednesday, 28 Nov 2018 

Nov 28 (Reuters) - Merck & Co Inc ::EUROPEAN COMMISSION APPROVES MERCK’S DELSTRIGO™ (DORAVIRINE / LAMIVUDINE / TENOFOVIR DISOPROXIL FUMARATE), A ONCE-DAILY FIXED-DOSE COMBINATION TABLET AS A COMPLETE REGIMEN AND PIFELTRO™ (DORAVIRINE), AN NNRTI, BOTH FOR THE TREATMENT OF HIV-1 IN APPROPRIATE PATIENTS.MERCK - APPROVALS BASED ON FINDINGS FROM PHASE 3 DRIVE-AHEAD & DRIVE-FORWARD TRIALS EVALUATING EFFICACY, SAFETY OF DELSTRIGO, PIFELTRO THROUGH 96 WEEKS.MERCK & CO - AVAILABILITY FOR DELSTRIGO AND PIFELTRO IN EU IS ANTICIPATED TO BEGIN IN H1 2019.  Full Article

Cold Genesys Announces Clinical Trial Collaboration To Evaluate Keytruda Combo Therapy In Bladder Cancer
Wednesday, 28 Nov 2018 

Nov 28 (Reuters) - Merck & Co Inc ::COLD GENESYS ANNOUNCES CLINICAL TRIAL COLLABORATION TO EVALUATE THE COMBINATION OF CG0070 AND KEYTRUDA® (PEMBROLIZUMAB) IN BLADDER CANCER.COLD GENESYS INC - ENTERED INTO CLINICAL COLLABORATION WITH MERCK.COLD GENESYS - CO WILL SPONSOR PHASE 2 CLINICAL STUDY, ADDITIONAL DETAILS OF COLLABORATION WERE NOT DISCLOSED.  Full Article

Evelo Enters Into Clinical Trial Collaboration Agreement With Merck
Tuesday, 27 Nov 2018 

Nov 27 (Reuters) - Evelo Biosciences Inc ::EVELO ENTERS INTO CLINICAL TRIAL COLLABORATION AGREEMENT WITH MERCK.EVELO BIOSCIENCES INC - EXPECTS TO COMMENCE CLINICAL TRIAL IN FIRST HALF OF 2019.EVELO BIOSCIENCES INC - COLLABORATION WILL EVALUATE EDP1503 IN COMBINATION WITH KEYTRUDA MERCK'S ANTI-PD-1 THERAPY, IN MULTIPLE CANCER INDICATIONS.EVELO BIOSCIENCES INC - COLLABORATION WILL EVALUATE EDP1503 IN COMBINATION WITH KEYTRUDA (PEMBROLIZUMAB).  Full Article

FDA Approves Merck's Keytruda For Treatment Of Patients
Friday, 9 Nov 2018 

Nov 9 (Reuters) - Merck & Co Inc ::FDA APPROVES MERCK’S KEYTRUDA® (PEMBROLIZUMAB) FOR THE TREATMENT OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) WHO HAVE BEEN PREVIOUSLY TREATED WITH SORAFENIB.MERCK SAYS APPROVAL WAS BASED ON DATA FROM KEYNOTE-224, A SINGLE-ARM, OPEN-LABEL, MULTICENTER TRIAL.  Full Article

Syndax To Host Conference Call To Provide Update On The Phase 3 Breast Cancer Trial (E2112)
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Syndax Pharmaceuticals Inc ::SYNDAX TO HOST CONFERENCE CALL TO PROVIDE UPDATE ON THE PHASE 3 BREAST CANCER TRIAL (E2112) AND TO ANNOUNCE ITS REGISTRATION TRIAL OF ENTINOSTAT WITH KEYTRUDA IN PD-(L)1 REFRACTORY NON-SMALL CELL LUNG CANCER.- ENROLLMENT COMPLETED IN E2112; PFS NOT STATISTICALLY SIGNIFICANT.TRIAL CONTINUES AS PLANNED HAVING PASSED 3RD INTERIM ANALYSIS FOR OS WITH ADDITIONAL PLANNED OS ANALYSES EVERY 6 MONTHS.PLANS TO INITIATE RANDOMIZED REGISTRATION ENABLING TRIAL COMPARING ENTINOSTAT-KEYTRUDA COMBINATION TO STANDARD OF CARE CHEMOTHERAPY.ANTICIPATES BEGINNING COMPARING ENTINOSTAT-KEYTRUDA COMBINATION TO STANDARD OF CARE CHEMOTHERAPY TRIAL IN H1 2019.ANTICIPATES TOP-LINE DATA FROM TRIAL COMPARING ENTINOSTAT-KEYTRUDA COMBINATION TO STANDARD OF CARE CHEMOTHERAPY IN H2 2020.  Full Article

Merck & Co Says Has Capacity To Enter Into Deals Of All Sizes
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Merck & Co Inc ::CEO SAYS CO HAS CAPACITY TO ENTER INTO DEALS OF ALL SIZES - CONF. CALL.CEO SAYS "BELIEVE WE RUN THE (ANIMAL HEALTH) BUSINESS VERY WELL INSIDE THE COMPANY, COMPARED TO COMPETITORS".  Full Article

Bioline Rx Ltd - Presents Top-Line Results From Phase 2A Combat/Keynote-202 Study In Pancreatic Cancer At Esmo 2018 Congress
Friday, 19 Oct 2018 

Oct 19 (Reuters) - BioLine RX Ltd ::BIOLINE RX LTD - PRESENTS TOP-LINE RESULTS FROM PHASE 2A COMBAT/KEYNOTE-202 STUDY IN PANCREATIC CANCER AT ESMO 2018 CONGRESS.BIOLINE - BL-8040 IN COMBINATION WITH KEYTRUDA DEMONSTRATED ENCOURAGING DISEASE CONTROL, OVERALL SURVIVAL IN PATIENTS WITH METASTATIC PANCREATIC CANCER.BIOLINE RX LTD - TRIPLE COMBINATION EXPANSION COHORT (BL-8040 + KEYTRUDA (PEMBROLIZUMAB) + CHEMOTHERAPY) TO COMMENCE BY YEAR-END.BIOLINE RX LTD - RESULTS SUPPORT FURTHER DEVELOPMENT OF COMBINATION AND EXPANSION OF COLLABORATION.BIOLINE RX LTD - TREATMENT REGIMEN WAS SAFE AND WELL TOLERATED.  Full Article

Imaginab Announces Collaboration With Merck For Cd8 T Cell I/O Imaging Agent
Monday, 8 Oct 2018 

Oct 8 (Reuters) - Merck & Co Inc ::IMAGINAB ANNOUNCES COLLABORATION WITH MERCK FOR CD8 T CELL I/O IMAGING AGENT.IMAGINAB - MERCK TO BUY CO'S NOVEL MINIBODY CD8 T CELL IMAGING AGENT FOR USE IN IMMUNO-ONCOLOGY CLINICAL TRIALS FOR MULTIPLE TYPES OF CANCERS.IMAGINAB - MERCK IS MAKING EQUITY INVESTMENT IN CO'S SERIES B FINANCING ROUND.  Full Article

Pharma industry returns on R&D investment hit 9-year low

LONDON, Dec 19 The cost of developing a new drug has nearly doubled since 2010 and the world's 12 biggest drugmakers are making the lowest return on their R&D investments in nine years, according to Deloitte.