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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

FDA Approves Merck's Keytruda In Combination With Inlyta As First-Line Treatment For Advanced Renal Cell Carcinoma
Monday, 22 Apr 2019 

April 22 (Reuters) - Merck & Co Inc ::FDA APPROVES MERCK’S KEYTRUDA® (PEMBROLIZUMAB) IN COMBINATION WITH INLYTA® (AXITINIB) AS FIRST-LINE TREATMENT FOR PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC).MERCK - FDA APPROVES KEYTRUDA (PEMBROLIZUMAB) IN COMBINATION WITH INLYTA AS FIRST-LINE TREATMENT FOR PATIENTS WITH ADVANCED RENAL CELL CARCINOMA.  Full Article

Agilent Receives An Expanded FDA Approval For Its Companion Diagnostic In NSCLC
Wednesday, 17 Apr 2019 

April 16 (Reuters) - Agilent Technologies Inc ::AGILENT RECEIVES AN EXPANDED FDA APPROVAL FOR ITS COMPANION DIAGNOSTIC IN NSCLC.U.S. FOOD AND DRUG ADMINISTRATION HAS UPDATED ITS APPROVAL OF COMPANY'S PD-L1 IHC 22C3 PHARMDX ASSAY.AGILENT TECHNOLOGIES - PD-L1 IHC 22C3 PHARMDX CAN NOW BE USED TO IDENTIFY A BROADER RANGE OF NSCLC PATIENTS FOR FIRST-LINE TREATMENT WITH KEYTRUDA.  Full Article

Merck Says ASPECT-NP Trial Demonstrated Non-Inferiority Of Zerbaxa To Meropenem For Ventilated Nosocomial Pneumonia In Primary, Key Secondary Endpoints
Saturday, 13 Apr 2019 

April 13 (Reuters) - Merck & Co Inc ::RESULTS OF PHASE 3 TRIAL EVALUATING MERCK’S ZERBAXA® (CEFTOLOZANE AND TAZOBACTAM) VERSUS MEROPENEM FOR TREATMENT OF ADULT PATIENTS WITH VENTILATED NOSOCOMIAL PNEUMONIA (VNP) TO BE PRESENTED AT ECCMID 2019.MERCK - ASPECT-NP TRIAL DEMONSTRATED NON-INFERIORITY OF ZERBAXA TO MEROPENEM FOR VENTILATED NOSOCOMIAL PNEUMONIA IN PRIMARY, KEY SECONDARY ENDPOINTS.MERCK - CO SUBMITTED SUPPLEMENTAL NDA TO U.S. FDA, EUROPEAN MEDICINES AGENCY SEEKING REGULATORY APPROVAL FOR ZERBAXA FOR POTENTIAL NEW INDICATION.FDA PRESCRIPTION DRUG USER FEE ACT (PDUFA) DATE IS JUNE 3, 2019.  Full Article

Astrazeneca Says Lynparza Approved In EU For Treatment Of Germl
Wednesday, 10 Apr 2019 

April 10 (Reuters) - AstraZeneca PLC ::LYNPARZA APPROVED IN EU FOR THE TREATMENT OF GERML.LYNPARZA APPROVED IN EU FOR TREATMENT OF GERMLINE BRCA-MUTATED HER2-NEGATIVE ADVANCED BREAST CANCER.  Full Article

Merck & Co Inc Reports 19.9 Pct Passive Stake In NGM Biopharmaceuticals Inc As Of April 8
Tuesday, 9 Apr 2019 

April 9 (Reuters) - Merck & Co Inc ::MERCK & CO INC REPORTS 19.9 PERCENT PASSIVE STAKE IN NGM BIOPHARMACEUTICALS INC AS OF APRIL 8 - SEC FILING.  Full Article

Merck & Co Inc Says CEO Kenneth C. Frazier's 2018 Compensation $20.9 Mln Versus $17.6 Mln In 2017
Monday, 8 Apr 2019 

April 8 (Reuters) - Merck & Co Inc ::MERCK & CO INC - CEO KENNETH C. FRAZIER'S 2018 COMPENSATION $20.9 MILLION VERSUS $17.6 MILLION IN 2017.MERCK & CO INC SAYS CFO ROBERT DAVIS' FY 2018 TOTAL COMPENSATION WAS $6.6 MILLION VERSUS $6.3 MILLION IN FY 2017 - SEC FILING.MERCK - REASONABLE ESTIMATION OF RATIO OF CEO’S 2018 COMPENSATION TO MEDIAN COMPENSATION IS 228 TO 1 (INCLUDING VALUE OF DEFERRED COMPENSATION CREDIT).MERCK & CO INC - RECOMMENDS VOTE 'AGAINST' SHAREHOLDER PROPOSAL CONCERNING AN INDEPENDENT BOARD CHAIRMAN.MERCK & CO INC - RECOMMENDS VOTE 'AGAINST' SHAREHOLDER PROPOSAL CONCERNING DRUG PRICING.  Full Article

Merck's Keytruda Approved In China For First-Line Treatment For A Form Of Lung Cancer
Monday, 1 Apr 2019 

April 1 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) APPROVED IN CHINA FOR FIRST-LINE TREATMENT OF METASTATIC NONSQUAMOUS NON-SMALL CELL LUNG CANCER (NSCLC) IN COMBINATION WITH CHEMOTHERAPY.MERCK - CONTINUED APPROVAL MAY BE CONTINGENT UPON VERIFICATION AND DESCRIPTION OF CLINICAL BENEFIT IN CHINESE PATIENTS IN A CONFIRMATORY TRIAL.  Full Article

Selumetinib Granted U.S. Breakthrough Therapy Designation In Neurofibromatosis Type 1
Monday, 1 Apr 2019 

April 1 (Reuters) - Merck & Co Inc ::SELUMETINIB GRANTED U.S. BREAKTHROUGH THERAPY DESIGNATION IN NEUROFIBROMATOSIS TYPE 1.MERCK & CO INC - DESIGNATION BASED ON PHASE 2 SPRINT TRIAL IN PEDIATRIC PATIENTS WITH NF1 PLEXIFORM NEUROFIBROMAS.MERCK & CO INC - SELUMETINIB IS A MEK 1/2 INHIBITOR BEING CO-DEVELOPED BY ASTRAZENECA AND MERCK.  Full Article

Astrazeneca Says Selumetinib Gets Breakthrough Therapy Designation
Monday, 1 Apr 2019 

April 1 (Reuters) - AstraZeneca PLC ::SELUMETINIB GETS BREAKTHROUGH THERAPY DESIGNATION.BREAKTHROUGH THERAPY DESIGNATION BASED ON PHASE II SPRINT TRIAL IN PAEDIATRIC PATIENTS WITH NF1 PLEXIFORM NEUROFIBROMAS.SELUMETINIB IS A MEK 1/2 INHIBITOR BEING CO-DEVELOPED BY ASTRAZENECA AND MERCK & CO .  Full Article

Merck And NGM Bio Announce Extension Of Broad, Multi-Year Strategic Collaboration To 2022
Wednesday, 20 Mar 2019 

March 20 (Reuters) - Merck & Co Inc ::MERCK AND NGM BIO ANNOUNCE EXTENSION OF BROAD, MULTI-YEAR STRATEGIC COLLABORATION TO 2022.MERCK & CO INC - MERCK TO RETURN GDF15 RECEPTOR AGONIST PROGRAM TO NGM.MERCK & CO INC - COLLABORATION WILL CONTINUE TO FOCUS ON DISCOVERY AND DEVELOPMENT OF NOVEL BIOLOGIC THERAPEUTICS ACROSS A RANGE OF THERAPEUTIC AREAS.MERCK & CO INC - MERCK WILL TERMINATE ITS LICENSE TO NGM'S GROWTH DIFFERENTIATION FACTOR 15 (GDF15) RECEPTOR AGONIST PROGRAM.MERCK & CO INC - DURING TWO-YEAR EXTENSION PERIOD, MERCK WILL CONTINUE TO FUND NGM'S RESEARCH AND DEVELOPMENT EFFORTS.MERCK & CO INC - RETAINS ONE ADDITIONAL TWO-YEAR EXTENSION OPTION THAT IS EXERCISABLE IN 2021.MERCK - MERCK WILL MAKE ADDITIONAL PAYMENTS TOTALING UP TO $20 MILLION IN SUPPORT OF NGM'S RESEARCH AND DEVELOPMENT ACTIVITIES DURING EXTENSION PERIOD.MERCK & CO - MERCK'S DECISION TO TERMINATE GDF15 PROGRAM, A RIGHT STIPULATED IN AGREEMENT, DOES NOT IMPACT REMAINDER OF COLLABORATION ARRANGEMENT.MERCK & CO - UPON LICENSE TERMINATION, CO TO GRANT TO NGM EXCLUSIVE LICENSE UNDER CO'S INTELLECTUAL PROPERTY RELATED TO GDF15 RECEPTOR AGONIST PROGRAM.  Full Article

UPDATE 1-Merck's Keytruda wins FDA approval as combination therapy for kidney cancer

April 22 The U.S. Food and Drug Administration has approved Merck & Co Inc's cancer therapy, Keytruda, as part of a combination therapy for previously untreated patients with the most common type of kidney cancer, the company said on Monday.