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Stock Market & Financial Investment News

News Breaks
February 5, 2014
06:18 EDTAMGN, MRKAmgen, Merck collaborate on combination treatment for advanced melanoma
Amgen (AMGN) and Merck (MRK), known as MSD outside the United States and Canada, announced that they have entered into an agreement through a subsidiary to evaluate the safety and efficacy of talimogene laherparepvec, an investigational oncolytic immunotherapy, combined with MK-3475, an investigational anti-PD-1 immunotherapy, in a Phase 1b/2 study of patients with mid- to late-stage melanoma. The multicenter, open-label clinical trial will be conducted in two parts and is planned to begin in the fall of 2014. Phase 1b is designed to determine the safety and tolerability of talimogene laherparepvec in combination with MK-3475 in patients with previously untreated, unresected, stage IIIB to IVM1a melanoma. The Phase 2 portion will evaluate efficacy, as assessed by the confirmed objective response rate, with talimogene laherparepvec in combination with MK-3475 versus MK-3475 alone in patients with previously untreated, unresected, stage IIIB to IVM1c melanoma. The study will also evaluate the efficacy of treatment with talimogene laherparepvec in combination with MK-3475 following disease progression on MK-3475 alone.
News For AMGN;MRK From The Last 14 Days
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August 28, 2014
09:18 EDTAMGNAmgen anounces Evolocumab YUKAWA-2 study meets co-primary endpoints
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09:04 EDTAMGNAmgen submits evolocumab BLA to FDA
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August 27, 2014
09:53 EDTMRKOn The Fly: Analyst Initiation Summary
Bristol-Myers (BMY) initiated with a Hold at Deutsche Bank... ASML (ASML) initiated with a Hold at Stifel... Akamai (AKAM) initiated with an Outperform at RW Baird... Concur (CNQR) initiated with a Neutral at DA Davidson... CyrusOne (CONE) initiated with a Neutral at Citigroup... Eli Lilly (LLY) initiated with a Buy at Deutsche Bank... Garmin (GRMN) initiated with a Neutral at RW Baird... Merck (MRK) initiated with a Hold at Deutsche Bank... NetSuite (N) initiated with a Buy at DA Davidson... Oracle (ORCL) initiated with a Neutral at DA Davidson... Oxford Industries (OXM) initiated with a Buy at Wunderlich... Pfizer (PFE) initiated with a Buy at Deutsche Bank... ServiceNow (NOW) initiated with a Buy at DA Davidson... Workday (WDAY) initiated with a Neutral at DA Davidson... MannKind (MNKD) initiated with a Buy at Jefferies... STMicroelectronics (STM) initiated with an Underperform at Credit Suisse... Kirkland's (KIRK) initiated with an Outperform at Barrington.
09:20 EDTAMGNFDA grants Amgen priority review designation for ivabradine
Amgen announced the U.S. Food and Drug Administration has granted priority review designation for ivabradine for the treatment of chronic heart failure. Ivabradine is an oral drug that inhibits the If current in the sinoatrial node, the body's cardiac pacemaker. The New Drug Application is based on global clinical trial data from the Phase 3 SHIFT, or Systolic Heart failure treatment with the If inhibitor ivabradine Trial), study. The SHIFT study compared ivabradine to placebo on top of standard-of-care therapies, including beta-blockers, in more than 6,500 patients in sinus rhythm with reduced left ventricular function and heart rate greater than 70 beats per minute.
06:42 EDTMRKMerck initiated with a Hold at Deutsche Bank
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August 26, 2014
11:21 EDTAMGNAmgen added to short term buy list at Deutsche Bank
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08:01 EDTMRKPfizer, Merck to collaborate on study evaluating anti-cancer combination regimen
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August 25, 2014
16:17 EDTAMGNWestern Digital CFO Leyden to retire, Olivier Leonetti to succeed
Western Digital (WDC) announced that CFO Tim Leyden is retiring. He is being succeeded by Olivier Leonetti, who has served as vice president, finance at Amgen (AMGN) from 2011. Leyden will remain with the company through January 2015 in a transition role and advisory capacity to president and chief executive officer Steve Milligan and to Leonetti for an interim period to ensure a smooth transition. The changes are effective as of September 8.
16:13 EDTMRKOn The Fly: Closing Wrap
Stocks began the session in positive territory and proceeded to tack on gains throughout the morning. Despite a disappointing report on new home sales in July, the S&P surpassed the 2,000 level for the first time before noon. The market pared its gains shortly after the milestone was reached and drifted for the remainder of the session on light volume, as trading activity may be restrained all week ahead of the Labor Day weekend. ECONOMIC EVENTS: In the U.S., the Chicago Fed's National Activity index jumped to 0.39 in July from an upwardly revised 0.21 in June. Markit's preliminary August services PMI came in at 58.5, which was down from a prior reading of 60.8 but above the 58.0 consensus projection. New home sales dropped 2.4% to a 412K rate in July, missing expectations for them to have risen to a 430K annualized rate. COMPANY NEWS: Shares of InterMune (ITMN) surged $19.05, or 35.41%, to $72.85 after the company agreed to be acquired by Roche (RHHBY) for $74.00 per share in an all-cash transaction. The deal announcement comes less than two weeks after Bloomberg reported that Roche, along with big pharma peers Sanofi (SNY) and GlaxoSmithKline (GSK), had made takeover bids for the smaller drugmaker. A number of other biotech companies gained following the deal announcement, including bigger names like Gilead (GILD) and Celgene (CELG) and smaller ones such as Achillion Pharmaceuticals (ACHN) and Receptos (RCPT)... Burger King (BKW) shares rose $5.29, or 19.51%, to $32.40 after the company confirmed it is in talks regarding a potential strategic transaction with Canadian donut chain Tim Hortons (THI). Shares of Tim Horton's trading in New York also gained $11.88, or 18.91%, to $74.72 following the confirmation of news first reported by The Wall Street Journal. MAJOR MOVERS: Among the other notable gainers was Advaxis (ADXS), which advanced 75c, or 23.08%, to $4.00 after announcing it has entered into a clinical trial collaboration agreement with Merck (MRK). Also rising were shares of Comtech (CMTL), which jumped $1.70, or 4.84%, to $36.81 after Reuters said the company is working with Citigroup to explore a potential sale. Among the noteworthy losers was Chinese internet and software company Qihoo 360 Technology (QIHU), which fell $7.88, or 7.74%, to $93.87 despite reporting second quarter earnings and revenue that beat analysts' estimates. Also lower were shares of GrubHub (GRUB), which fell $3.60, or 8.42%, to $39.16 after filing to sell 10M shares of common stock. INDEXES: The Dow gained 75.65, or 0.44%, to 17,076.87, the Nasdaq rose 18.80, or 0.41%, to 4,557.35, and the S&P 500 advanced 9.54, or 0.48%, to 1,997.94.
09:11 EDTMRKOn The Fly: Pre-market Movers
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05:17 EDTMRKAdvaxis, Merck enter clinical trial collaboration agreement
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August 19, 2014
05:11 EDTAMGNGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
07:57 EDTMRKCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
06:54 EDTAMGNAmgen shares should 'grind higher' this year, says RBC Capital
RBC Capital expects Amgen shares to "grind higher" this year driven by a greater appreciation of pipeline programs, the Analyst Day on October 28, an expected filing of the PCSK-9 program soon, and positive Ph iiB anti-CGRP migraine data expected year-end. Shares are Outperform rated.
August 14, 2014
12:01 EDTAMGNThird Point gives quarterly update on stakes
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
11:52 EDTAMGNThird Point discloses new stakes in Finisar, Amgen, Ally Financial

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