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Stock Market & Financial Investment News

News Breaks
May 23, 2014
10:55 EDTAMGN, AMGN, NVS, NVS, MRK, MRK, INCY, INCY, GSK, GSK, EXEL, EXEL, BMY, BMY, AZN, AZN, ARRY, ARRY, RHHBY, RHHBYLeerink's pharma and biotech analysts hold an analyst/industry conference call
Biotech and Pharmaceuticals Analysts Liang and Kapur discuss the market opportunity and role of immunotherapy in the adjuvant melanoma setting ahead of the upcoming ASCO Annual Meeting on an Analyst/Industry conference call. Relevant companies AMGN, ARRY, AZN, BMY, EXEL, GSK, INCY, MRK, NVS and RHHBY may be discussed on the Analyst/Industry conference call to be held on May 28 at 11:30 am.
News For AMGN;ARRY;AZN;BMY;EXEL;GSK;INCY;MRK;NVS;RHHBY From The Last 14 Days
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February 2, 2016
07:24 EDTMRKSanofi, Merck mulling exiting vaccine JV, Bloomberg reports
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07:03 EDTARRYArray BioPharma plans to submit binimetinib for marketing approval in 1H16
In December 2015, Array reported top-line results from the ongoing Phase 3 NEMO clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma. The study met its primary endpoint of improving progression-free survival compared with dacarbazine treatment, with a hazard ratio of 0.62, [95% CI 0.47-0.80] and a p-value of less than 0.001. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm. In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients. Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical conference in 2016. In addition, Array expects top-line results from Part 1 of the COLUMBUS trial in the first half of 2016 and projects a regulatory filing of binimetinib and encorafenib in 2016. In October 2015, Part 2 of COLUMBUS achieved its target patient enrollment. The MILO Phase 3 study in patients with low-grade serous ovarian cancer continues to enroll patients, and Array estimates enrollment to be complete in 2016 with the availability of top-line data, along with a projected regulatory filing, in 2017. Based on the strength of the Phase 2 combination data with encorafenib in patients with BRAF-mutant colorectal cancer shared at the 2015 European Society of Medical Oncology's (ESMO) World Congress of Gastrointestinal Cancer, Array plans to initiate a Phase 3 global registration trial in that patient population in 2016.
07:03 EDTARRYArray BioPharma reports Q2 EPS (17c), consensus (6c)
Reports Q2 revenue $35.43M, consensus $32.7M.
06:44 EDTMRKMerck volatility elevated into Q4 and outlook
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06:32 EDTGSKGSK, J&J back Index Ventures' $1B biotech business spinoff, Reuters says
GlaxoSmithKline (GSK) and Johnson & Johnson (JNJ) will back a new spinoff from Index Ventures, which is spinning off its biotech portfolio into a new $1B entity, Reuters reports. The New Medicxi Ventures business will be helmed by the existing life sciences team from Index and will include all the current biotech portfolio firms, the report says. Medicxi raises $229M for a new fund in Europe with GSK and J&J each putting in 25%, Reuters reports. Reference Link
February 1, 2016
11:57 EDTARRYDana-Farber, Array BioPharma to collaborate on immuno-oncology research
Dana-Farber Cancer Institute announced announced an immuno-oncology collaboration with potential applicability in a wide range of oncology indications with Array BioPharma. The research team at Dana-Farber's Robert and Renee Belfer Center for Applied Cancer Science will work with Array scientists on novel immune-oncology targets with the goal of bringing innovative medicines to patients. The collaboration will leverage the Belfer Center's proprietary immuno-oncology platform. Combining Dana Farber's oncology expertise with the Array's proficiency in drug discovery provides a unique opportunity to accelerate drug discovery of effective medicines for patients with unmet medical need.
11:02 EDTRHHBYRoche: Updated cervical cancer screening guidelines support use of cobas test
Roche announced that recently updated cervical cancer screening guidelines from the American College of Obstetricians and Gynecologists support the use of its cobas HPV Test for primary cervical cancer screening as an alternative to current cytology-based cancer screening methods in women 25 and older. The College's revised Practice Bulletin 157, published in the January issue of Obstetrics & Gynecology, reinforces similar guidance issued in 2015 by the Society for Gynecologic Oncology and the American Society for Colposcopy and Cervical Pathology. The cobas HPV Test was approved by the FDA in 2011 for use in screening women 21 and older with unclear Pap test results and for co-testing with a Pap test in women 30 and older. The FDA approved it for first-line primary cervical cancer screening for women 25 and older in April 2014 following a unanimous recommendation from the independent Microbiology Devices Panel of the FDA's Medical Devices Advisory Committee. Currently utilized by more than 250 labs in the U.S., the cobas HPV Test is the only test approved in the U.S. for all three HPV testing options now supported by three major medical societies.
08:25 EDTAMGNAlder pullback Friday a buying opportunity, says Leerink
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08:07 EDTEXELExelixis announces positive overall survival results from Meteor trial
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06:58 EDTBMYPortola Pharma licensed right to andexanet alfa to Bristol-Myers and Pfizer
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06:57 EDTBMYBristol-Myers and Pfizer sign collaboration with Portola Pharmaceuticals
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January 31, 2016
16:13 EDTRHHBYGenentech receives orphan designation for Avastin in mesothelioma
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January 29, 2016
17:12 EDTMRKOn The Fly: Top stock stories for Friday
Stocks began the session in positive territory and remained there throughout the day. The early strength was attributed to the surprise cut in interest rates by the Bank of Japan that put the country in a negative interest rate scenario. The market gained strength throughout the day and put in gains of almost 2.5% in what was a broad based advance for the major averages. January closed out with two winning weeks, but the month was still a very bad one for stocks, as the S&P lost over 5% even after today's strong showing. ECONOMIC EVENTS: In the U.S., the Commerce Department's first read on fourth quarter gross domestic product came in at 0.7% annualized growth, below the already anemic 0.8% growth forecast. The Chicago PMI business barometer bounced to 55.6 in January, topping forecasts for a 45.3 reading. The University of Michigan consumer sentiment index slipped to 92.0 in the final January print, missing the 93.0 reading that was forecast. In a surprise move in Asia, the Bank of Japan introduced a rate of minus 0.1% on certain excess holdings of cash while maintaining the pace of its asset purchases. Japan also reported data pointing to a softening economy, as total CPI grew 0.2% year-over-year in December, core CPI rose at only a 0.1% pace and industrial production fell a preliminary 1.4% month-over-month in December. COMPANY NEWS: Shares of Amazon (AMZN) declined 7.6% to $587 after the company's fourth quarter results came in below expectations. Meanwhile, Microsoft (MSFT), which reported better than expected earnings after last night's closing bell, gained 5.8% to $55.09... Confirming a news report that broke late in the day yesterday, Xerox (XRX) announced plans to separate into two independent publicly-traded companies: one focused on Document Technology and another Business Process Outsourcing company. Xerox also announced an agreement related to the governance of the Business Process Outsourcing company under which six directors of the new company will be selected by Xerox and three will be selected by current Xerox shareholder Carl Icahn... Chevron (CVX) reported a quarterly loss due to taking impairments and other charges of $1.1B. The company, which also reported that its average sales price per barrel of crude oil and natural gas liquids in the U.S. was $35 in fourth quarter, down from $66 a year ago, edged up 0.7% to $86.44. MAJOR MOVERS: Among the notable gainers was Axiall (AXLL), which jumped 83% to $17.94 after it came to light that the company received, and rejected, an unsolicited proposal from Westlake Chemical (WLK) offering to acquire the company for $20 per share in cash and stock. Also higher were Visa (V) and Mastercard (MA), which gained 7% and 6.4%, respectively, after reporting quarterly earnings. Among the notable losers was Gilead (GILD), which fell 5.5% to $82.70 after rival Merck (MRK) received FDA approval for its own hepatitis C drug. Also potentially weighing on Gilead shares was the fact that competitor AbbVie (ABBV) announced financial results for the fourth quarter, including sales of Viekira Pak, its own hep C treatment, that fell short of estimates. AbbVie fell 2.3% to $54.58 following its quarterly report. INDEXES: The Dow rose 396.66, or 2.47%, to 16,466.30, the Nasdaq gained 107.28, or 2.38%, to 4,613.95, and the S&P 500 added 46.88, or 2.48%, to 1,940.24.
13:38 EDTAMGNAmgen wins right to allege willful infringement in Praluent suit, Markman says
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09:44 EDTMRKGilead slips as another drug enters Hepatitis C virus space
Shares of Gilead (GILD), a leader in the hepatitis C virus treatment space, are sliding this morning after one competitor's hep C drug was granted FDA approval and another's sales disappointed. Additionally, Gilead reported its own news, announcing a shakeup of the roles held by its top executives. MERCK APPROVAL: Merck (MRK) announced last night that the FDA has approved Zepatier for the treatment of adult patients with chronic hepatitis C virus, or HCV, genotype, or GT, 1 or GT4 infection. Merck has established a list price of $54,600 for a 12-week regimen of Zepatier, which the company said it believes to "be in the range of net prices for other commonly used HCV direct-acting antiviral regimens at 12 weeks of therapy." In contrast, a 12-week regimen of Gilead's Sovaldi is reported to be priced at $84,000. Merck added that it anticipates that this price, as well as its "strategy to seek broad coverage across commercial and public segments," will help broaden and accelerate patient access to treatment. ABBVIE RESULTS: Meanwhile, Gilead competitor AbbVie (ABBV) announced financial results for the fourth quarter this morning. AbbVie announced Q4 sales of Viekira Pak, its own hep C treatment, of $554M, including U.S. sales of $197M and international sales of $357M. Analysts expected AbbVie to report Q4 Viekira sales of $568.5M, according to a Bloomberg consensus estimate that factored in four forecasts. EXECUTIVE CHANGES: Additionally, Gilead announced this morning that current chairman and CEO John Martin will assume the role of executive chairman, effective March 10. John Milligan, currently president and COO, will be promoted to CEO and appointed to the company's board. PRICE ACTION: In morning trading, Gilead shares slipped 3.5% to $84.50, while AbbVie fell 2.4% to $54.53 and Merck (MRK) gained 1% to $49.75.
07:53 EDTNVSNovartis management to meet with JPMorgan
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07:49 EDTBMYBristol-Myers, AbbVie receive 'positive' CHMP opinion for Empliciti
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07:37 EDTNVSRadius Health should be bought aggressively at current prices, says Canaccord
Canaccord said they would be aggressive buyers of Radius Health (RDUS) especially at current share prices. The firm cited its partnership with Novartis (NVS), its drug pipeline, and expectations for an FDA filing of abaloparatide in the first quarter of 2016. Canaccord reiterated its Buy rating and $85 price target on Radius Health shares.
07:11 EDTAZNAllergan enters into global agreement with AstraZeneca for ATM-AVI
Allergan announced that it has entered into a global agreement with AstraZeneca to develop and commercialize ATM-AVI, an investigational, fixed-dose antibiotic combining aztreonam and avibactam. Together, the two companies will evaluate the combination to treat serious infections caused by metallo betalactamase MBL-producing Gram-negative pathogens, a difficult-to-treat sub-type of carbapenem-resistant Enterobacteriaceae, or CRE, for which there are currently very limited treatments, thus presenting a new treatment option for patients with MBL-producing pathogens. Under the terms of the agreement, Allergan will maintain commercialization rights in the U.S. and Canada and AstraZeneca will maintain commercialization rights in all other countries.
05:33 EDTMRKStocks with implied volatility movement; VRX MRK
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