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Merck & Co Inc (MRK)

MRK on New York Consolidated

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17 Jan 2018
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Latest Key Developments (Source: Significant Developments)

Merck & Co Says Keytruda Phase 3 Keynote-189 Trial Met Its Dual Primary Endpoints
Tuesday, 16 Jan 2018 06:45am EST 

Jan 16 (Reuters) - Merck & Co Inc ::MERCK'S KEYTRUDA(R) (PEMBROLIZUMAB) SIGNIFICANTLY IMPROVED OVERALL SURVIVAL AND PROGRESSION-FREE SURVIVAL AS FIRST-LINE TREATMENT IN COMBINATION WITH PEMETREXED AND PLATINUM CHEMOTHERAPY FOR PATIENTS WITH METASTATIC NONSQUAMOUS NON-SMALL CELL LUNG CANCER (KEYNOTE-189).MERCK & CO INC - PIVOTAL PHASE 3 KEYNOTE-189 TRIAL MET ITS DUAL PRIMARY ENDPOINTS.MERCK & CO INC - ‍SAFETY PROFILE OF KEYTRUDA IN COMBINATION WAS CONSISTENT WITH THAT PREVIOUSLY OBSERVED​.  Full Article

Eisai, Merck Receive Breakthrough Therapy Designation From FDA For Lenvima, Keytruda
Tuesday, 9 Jan 2018 06:45am EST 

Jan 9 (Reuters) - Eisai Co Ltd <4523.T>::EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.EISAI AND MERCK RECEIVE BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR LENVIMA® (LENVATINIB MESYLATE) AND KEYTRUDA® (PEMBROLIZUMAB) AS COMBINATION THERAPY FOR ADVANCED AND/OR METASTATIC RENAL CELL CARCINOMA.  Full Article

Merck's Keytruda Significantly Improved Recurrence-Free Survival Compared To Placebo As Adjuvant Therapy
Monday, 8 Jan 2018 06:45am EST 

Jan 8 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) SIGNIFICANTLY IMPROVED RECURRENCE-FREE SURVIVAL COMPARED TO PLACEBO AS ADJUVANT THERAPY IN PATIENTS WITH STAGE 3 RESECTED HIGH-RISK MELANOMA (EORTC1325/KEYNOTE-054).MERCK & CO INC - PHASE 3 EORTC1325/KEYNOTE-054 TRIAL MET PRIMARY ENDPOINT OF RECURRENCE-FREE SURVIVAL.MERCK -SAFETY PROFILE OF KEYTRUDA IN TRIAL WAS CONSISTENT WITH THAT OBSERVED IN PREVIOUSLY REPORTED STUDIES INVOLVING PATIENTS WITH ADVANCED MELANOMA.MERCK & CO INC - IN ACCORDANCE WITH TRIAL PROTOCOL, STUDY WILL CONTINUE IN ORDER TO EVALUATE OTHER KEY ENDPOINTS, INCLUDING OVERALL SURVIVAL.  Full Article

FDA Accepts New Drug Applications For Merck's Doravirine
Monday, 8 Jan 2018 06:30am EST 

Jan 8 (Reuters) - Merck & Co Inc ::FDA ACCEPTS NEW DRUG APPLICATIONS FOR MERCK’S DORAVIRINE, THE COMPANY’S INVESTIGATIONAL NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI), FOR TREATMENT OF HIV-1 INFECTION.MERCK & CO INC - FDA HAS SET A TARGET ACTION DATE OF OCT. 23, 2018, FOR BOTH APPLICATIONS UNDER PRESCRIPTION DRUG USER FEE ACT.FDA ACCEPTS NEW DRUG APPLICATIONS FOR MERCK’S DORAVIRINE, THE COMPANY’S INVESTIGATIONAL NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI), FOR TREATMENT OF HIV-1 INFECTION.  Full Article

Lycera Corp Announces Initiation Of Phase 1b Study Of Novel Immuno-Oncology Candidate LYC-55716 In Combination With Pembrolizumab
Thursday, 4 Jan 2018 08:00am EST 

Jan 4 (Reuters) - Merck & Co Inc ::LYCERA CORP ANNOUNCES INITIATION OF PHASE 1B STUDY OF NOVEL IMMUNO-ONCOLOGY CANDIDATE LYC-55716 IN COMBINATION WITH PEMBROLIZUMAB.  Full Article

Merck’s Keytruda Approved In Japan For Use In The Treatment Of Patients With Urothelial Carcinoma
Tuesday, 2 Jan 2018 07:00am EST 

Jan 2 (Reuters) - Merck & Co Inc ::MERCK’S KEYTRUDA® (PEMBROLIZUMAB) APPROVED IN JAPAN FOR USE IN THE TREATMENT OF PATIENTS WITH UROTHELIAL CARCINOMA THAT IS UNRESECTABLE WITH RADICAL SURGERY WHO HAVE PROGRESSED FOLLOWING CANCER CHEMOTHERAPY.MERCK & CO INC - WILL MARKET KEYTRUDA IN JAPAN AND WILL PROMOTE IT WITH TAIHO PHARMACEUTICAL CO LTD.MERCK & CO INC - WITH THE APPROVAL, KEYTRUDA IS NOW INDICATED FOR USE IN FOUR TYPES OF CANCER IN JAPAN.  Full Article

FDA Approves SGLT2 Inhibitor Steglatro And Fixed-Dose Combination Steglujan For Adults With Type 2 Diabetes
Friday, 22 Dec 2017 07:00am EST 

Dec 22 (Reuters) - Merck & Co Inc ::FDA APPROVES SGLT2 INHIBITOR STEGLATRO™ (ERTUGLIFLOZIN) AND FIXED-DOSE COMBINATION STEGLUJAN™ (ERTUGLIFLOZIN AND SITAGLIPTIN) FOR ADULTS WITH TYPE 2 DIABETES.MERCK & CO INC - FDA APPROVED STEGLATRO TABLETS, AN ORAL SODIUM-GLUCOSE COTRANSPORTER 2 INHIBITOR, AND FIXED-DOSE COMBINATION STEGLUJAN TABLETS.MERCK & CO INC - IN ADDITION TO STEGLATRO & STEGLUJAN, FDA ALSO APPROVED FIXED-DOSE COMBINATION SEGLUROMET.  Full Article

Merck Provides Update On Keynote-061, A Phase 3 Study Of Keytruda (Pembrolizumab)
Thursday, 14 Dec 2017 04:45pm EST 

Dec 14 (Reuters) - Merck & Co Inc ::MERCK PROVIDES UPDATE ON KEYNOTE-061, A PHASE 3 STUDY OF KEYTRUDA® (PEMBROLIZUMAB) IN PREVIOUSLY TREATED PATIENTS WITH GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.MERCK PROVIDES UPDATE ON KEYNOTE-061, A PHASE 3 STUDY OF KEYTRUDA® (PEMBROLIZUMAB) IN PREVIOUSLY TREATED PATIENTS WITH GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA.MERCK & CO INC - PIVOTAL PHASE 3 KEYNOTE-061 TRIAL DID NOT MEET ITS PRIMARY ENDPOINT.MERCK & CO INC - CONTINUE TO EVALUATE KEYTRUDA FOR GASTRIC OR GEJ ADENOCARCINOMA THROUGH KEYNOTE-062.MERCK - CONTINUE TO EVALUATE KEYTRUDA FOR GASTRIC OR GEJ ADENOCARCINOMA THROUGH KEYNOTE-062.MERCK - ALSO CONTINUE TO EVALUATE KEYTRUDA FOR GASTRIC OR GEJ ADENOCARCINOMA WITH KEYNOTE-585.MERCK - PROGRESSION FREE SURVIVAL IN PD-L1 POSITIVE POPULATION DID NOT SHOW STATISTICAL SIGNIFICANCE IN KEYNOTE-061.MERCK & CO INC - NO NEW SAFETY SIGNALS WERE IDENTIFIED IN KEYNOTE-061.  Full Article

Merck Says Prevymis To Be Available In Canada By End Of December
Thursday, 14 Dec 2017 01:20pm EST 

Dec 14 (Reuters) - Merck & Co Inc ::MERCK & CO SAYS RECENTLY APPROVED PREVYMIS (LETERMOVIR) IS EXPECTED TO BE AVAILABLE IN CANADA BY END OF DECEMBER 2017.  Full Article

Newlink Genetics, Bps And Merck Sharp & Dohme Amended License & Collaboration Agreement
Monday, 11 Dec 2017 05:35pm EST 

Dec 11 (Reuters) - Merck & Co Inc ::NEWLINK GENETICS - ON DEC 5, BPS AND MERCK SHARP & DOHME CORP AMENDED LICENSE & COLLABORATION AGREEMENT DATED NOV 21, 2014.NEWLINK GENETICS-UNDER MERCK AMENDMENT, MODIFIED MERCK'S SUBLICENSE OF IP RIGHTS UNDER PHAC LICENSE AGREEMENT TO BE NON-EXCLUSIVE ON EBOLA SUDAN FIELD OF USE.NEWLINK GENETICS - AMENDMENT ALSO ADJUSTS EXPIRATION OF MERCK'S OBLIGATION TO PAY ROYALTIES TO BPS BASED ON ROYALTY TERM OF PHAC LICENSE AGREEMENT.  Full Article

Positive Keytruda lung cancer data sends Merck shares up 6 percent

Positive lung cancer results for Merck & Co Inc's blockbuster drug Keytruda assuaged investor concerns about delays in testing and the withdrawal of an application for European use of the drug, sending the drugmaker's shares up more than 6 percent.