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Merck & Co Inc (MRK.N)

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Latest Key Developments (Source: Significant Developments)

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

Merck discontinues MK-3682B and MK-3682C development programs
Friday, 29 Sep 2017 06:55am EDT 

Sept 29 (Reuters) - Merck & Co Inc : :Merck discontinues MK-3682B and MK-3682C development programs.Merck & Co Inc - company to focus on maximizing potential of Zepatier (Elbasvir and Grazoprevir).Merck - ‍decision made based on review of phase 2 efficacy data, considering of evolving marketplace, growing treatment options.  Full Article

Merck says Isentress HD now available in Canada
Tuesday, 12 Sep 2017 02:20pm EDT 

Sept 12 (Reuters) - Merck & Co Inc ::Now available in Canada: Isentress HD (raltegravir), a new once-daily option, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in appropriate patients.‍Availability of Isentress HD, a new 1200 mg once-daily dose of company's integrase strand transfer inhibitor, Isentress​.  Full Article

European Commission approves Merck’S KEYTRUDA (pembrolizumab)
Tuesday, 5 Sep 2017 06:30am EDT 

Sept 5 (Reuters) - Merck & Co Inc :European Commission approves Merck’s KEYTRUDA (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.Merck & Co Inc - ‍there was no statistically significant difference between KEYTRUDA and chemotherapy with respect to PFS​.Merck - ‍KEYTRUDA now approved for adults previously treated with platinum-containing chemotherapy, for adults ineligible for cisplatin-containing chemotherapy ​.Merck- ‍KEYTRUDA approved for use as monotherapy for treatment of locally advanced/metastatic urothelial carcinoma in adults who received prior platinum-containing chemotherapy​.  Full Article

CDER's Director Woodcock issues statement on investigational use of Keytruda
Thursday, 31 Aug 2017 11:50am EDT 

Aug 31 (Reuters) - Center for Drug Evaluation and Research: :Center for Drug Evaluation and Research director Janet Woodcock issues statement regarding safety concerns related to investigational use of Keytruda in multiple myeloma.  Full Article

U.S. FDA alerts about 2 clinical trials on hold evaluating Keytruda with multiple myeloma
Thursday, 31 Aug 2017 11:16am EDT 

Aug 31 (Reuters) - U.S. FDA :U.S. FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating Keytruda in patients with multiple myeloma.Says Merck was made aware of issue through external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017‍​.Says statement does not apply to patients taking Keytruda (pembrolizumab) for an approved indication​.Says on July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with the drug​.Says will be working with sponsors of Keytruda, PD-1/PD-l1 cancer drugs, clinical investigators to determine extent of safety issue.  Full Article

Merck announces results of REVEAL outcomes study of Anacetrapib
Tuesday, 29 Aug 2017 02:31am EDT 

Aug 29 (Reuters) - Merck & Co Inc :Merck announces results of REVEAL outcomes study of Anacetrapib, investigational medicine for cardiovascular disease.Merck- reviewing results of trial with external experts,will consider whether to file new drug applications with U.S. FDA and other regulatory agencies.The safety of Anacetrapib was generally consistent with data from earlier trials of the drug.However, a sub-study also showed that Anacetrapib accumulates in adipose tissue with prolonged dosing.  Full Article

Merck & Co says received investigative subpoena from california insurance commissioner’s fraud liaison bureau - sec filing
Tuesday, 8 Aug 2017 05:28pm EDT 

Aug 8 (Reuters) - Merck & Co Inc :Merck & co says recently received investigative subpoena from california insurance commissioner’s fraud liaison bureau - sec filing.Merck - the fraud liaison bureau investigating if cubist pharmaceuticals unlawfully induced presentation of false claims for cubicin to private insurers.Merck & co - investigative subpoena from fraud liaison bureau seeks information from jan 1, 2007 to present related to pricing and promotion of cubicin‍​.  Full Article

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Merck cyber attack may cost insurers $275 million: Verisk's PCS

NEW YORK Insurers could pay $275 million to cover the insured portion of drugmaker Merck & Co's loss from a cyber attack in June, according to a forecast by Verisk Analytics Inc's Property Claim Services (PCS) unit.