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Merck & Co Inc (MRK)

MRK on New York Consolidated

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

Merck announces any and all tender offers
Monday, 6 Nov 2017 08:56am EST 

Nov 6 (Reuters) - Merck & Co Inc :Merck announces any and all tender offers.Merck & Co Inc - ‍Offers are being made upon, and are subject to, terms and conditions set forth in offer to purchase, dated Nov. 6, 2017​.Merck & Co Inc - ‍Offers will expire at 5:00 p.m. on Nov. 13, 2017​.  Full Article

FDA approves roll-over combination study of BriaVax with pembrolizumab
Monday, 30 Oct 2017 08:30am EDT 

Oct 30 (Reuters) - Briacell Therapeutics Corp :FDA approves the roll-over combination study with checkpoint inhibitor immunotherapies to allow continued access to BriaVax in patients with advanced breast cancer.Briacell Therapeutics - ‍FDA approved roll-over combination study of BriaVax with pembrolizumab or ipilimumab.Briacell- ‍FDA approved roll-over combination study for patients previously treated with BriaVax from Phase I/IIa clinical trial in advanced breast cancer​.  Full Article

Merck withdraws European application for Keytruda
Friday, 27 Oct 2017 04:17pm EDT 

Oct 27 (Reuters) - Merck & Co Inc ::Merck provides update on European application for Keytruda (pembrolizumab) in combination with pemetrexed and carboplatin for first-line treatment of nonsquamous non-small cell lung cancer (NSCLC).Withdrawn European application for Keytruda in combination with pemetrexed, carboplatin as first-line treatment for metastatic nonsquamous NSCLC.Company is confident in clinical data from Keynote-021, Cohort G​.  Full Article

Merck says cyber attack to impact fourth quarter results
Friday, 27 Oct 2017 09:05am EDT 

Oct 27 (Reuters) - Merck & Co Inc :Merck & Co CFO says cyber attack will have similar impact on Q4 results as outlined in Q3.Merck says nearly 1 in 3 new U.S. lung cancer patients starting with Keytruda.Merck says pricing pressure on diabetes drug Januvia to continue.Merck CEO says business development an important priority, particularly bolt-on deals to enhance innovation.  Full Article

Merck reports Q3 loss per share of $0.02
Friday, 27 Oct 2017 06:45am EDT 

Oct 27 (Reuters) - Merck & Co Inc :Merck announces third-quarter 2017 financial results.Q3 non-GAAP earnings per share $1.11.Q3 GAAP loss per share $0.02.Q3 sales $10.3 billion versus I/B/E/S view $10.54 billion.Q3 earnings per share view $1.03 -- Thomson Reuters I/B/E/S.‍Company narrows and raises 2017 full-year revenue range to be between $40.0 billion and $40.5 billion​.Qtrly Januvia/Janumet sales $‍1,525​ million versus $1,554 million.‍Company narrows and raises 2017 full-year GAAP EPS range to be between $1.78 and $1.84​.‍Narrows and raises 2017 full-year non-GAAP EPS range to be between $3.91 and $3.97​.‍Third-quarter pharmaceutical sales decreased 3 percent to $9.2 billion, including a 1 percent positive impact from foreign exchange​.Qtrly Keytruda sales $‍1,047​ million versus $356 million.FY2017 earnings per share view $3.87, revenue view $40.32 billion -- Thomson Reuters I/B/E/S.Qtrly remicade sales $214 ‍​ million versus $311 million.Worldwide sales for Q3 included a 1 percent positive impact from foreign exchange​.Q3 GAAP loss per share reflects $2.35 billion charge related to formation of strategic oncology collaboration with Astrazeneca​.Qtrly revenue was unfavorably impacted by about $135 million from lost sales in certain markets related to cyber-attack​.Q3 ‍sales reduced by about $240 million due to borrowing from U.S. centers for disease control & prevention pediatric vaccine stockpile of Gardasil 9​.  Full Article

ACIP votes 8-7 to prefer GSK's shingles vaccine Shingrix over Merck's Zostavax
Wednesday, 25 Oct 2017 08:00am EDT 

Oct 25 (Reuters) - Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), responsible for U.S. vaccination schedules: :* Votes 8-7 to give GlaxoSmithKline's Shingrix preferential recommendation over Merck's Zostavax.  Full Article

AstraZeneca and Merck submit application for breast cancer drug in Japan
Monday, 23 Oct 2017 02:05am EDT 

By plc:‍ASTRAZENECA AND MSD RAPIDLY ADVANCE LYNPARZA IN JAPAN WITH A SECOND REGULATORY SUBMISSION​.‍JAPAN NDA IS BASED ON POSITIVE RESULTS FROM PHASE III OLYMPIAD TRIAL PUBLISHED IN NEW ENGLAND JOURNAL OF MEDICINE​.  Full Article

U.S. FDA accepts regulatory submission for lynparza
Wednesday, 18 Oct 2017 06:55am EDT 

Oct 18 (Reuters) - Merck & Co Inc ::U.S. FDA accepts regulatory submission for lynparza® (olaparib) in metastatic breast cancer and grants priority review.Merck & Co Inc - ‍a prescription drug user fee act (PDUFA) date is set for Q1 of 2018​.  Full Article

Aeglea Biotherapeutics announces clinical collaboration with Merck
Monday, 16 Oct 2017 08:00am EDT 

Oct 16 (Reuters) - Aeglea Bio Therapeutics Inc :Aeglea Biotherapeutics announces clinical collaboration with Merck to evaluate the combination of Aeglea’S AEB1102 (pegzilarginase) with Merck's Keytruda® (pembrolizumab) for the treatment of small cell lung cancer.Aeglea Bio Therapeutics Inc - ‍collaboration agreement is between Aeglea Biotherapeutics and Merck, through a subsidiary​.Aeglea Bio Therapeutics Inc - ‍additional details of collaboration were not disclosed​.Aeglea Bio Therapeutics Inc - ‍enrollment to multicenter phase 1/2 study​ is expected to begin in Q1 of 2018.  Full Article

Kalvista Pharmaceuticals announces collaboration with Merck
Tuesday, 10 Oct 2017 07:30am EDT 

Oct 10 (Reuters) - Kalvista Pharmaceuticals Inc :Kalvista Pharmaceuticals announces collaboration with Merck.Kalvista Pharmaceuticals - ‍investigational intravitreal DME candidate KVD001 phase 2 clinical trial still planned to initiate in 2017​.Kalvista Pharmaceuticals Inc - ‍Merck acquires 9.9% stake in Kalvista in private placement​.Kalvista Pharmaceuticals Inc - deal includes ‍$37 million upfront fee plus potential milestone payments and sales royalties​.Kalvista Pharmaceuticals Inc - ‍Kalvista also has granted to Merck a similar option to acquire investigational orally delivered molecules for DME​.Kalvista - ‍under deal terms, co granted to Merck rights including an option to acquire KVD001 through a period following completion of phase 2 trial.Kalvista - Co will fund, retain control over planned phase 2 clinical trial of KVD001, development of investigational oral DME compounds through phase 2​.Kalvista - eligible to get payments associated with exercise of options by Merck, achievement of milestones for each program potentially total $715 million​.  Full Article

BRIEF-Merck says First-Time Data For Keytruda In Patients With Previously Treated Advanced Hepatocellular Carcinoma To Be Presented At 2018 ASCO GI Symposium

* FIRST-TIME DATA FOR MERCK'S KEYTRUDA® (PEMBROLIZUMAB) IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED HEPATOCELLULAR CARCINOMA (HCC) TO BE PRESENTED AT 2018 ASCO GI SYMPOSIUM