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Stock Market & Financial Investment News

News Breaks
May 20, 2014
08:15 EDTQSII, EXEL, SGEN, MNK, CGIX, AHS, GILD, ARRYUBS to hold a conference
2014 Global Healthcare Conference to be held in New York on May 19-21 with webcasted company presentations to begin on May 20 at 8 am; not all company presentations may be webcasted. Webcast Link
News For ARRY;CGIX;EXEL;GILD;MNK;QSII;AHS;SGEN From The Last 14 Days
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January 29, 2016
10:16 EDTGILDOptions with increasing implied volatility: WMB W CERS RAD CRM GILD MNST
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09:44 EDTGILDGilead 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.
09:35 EDTGILDGilead falls, levels to watch
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09:34 EDTGILDActive equity options trading on open: AMZN MSFT FB AAPL GILD GE
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09:21 EDTGILDOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Gigamon (GIMO), up 17.7%... Fortinet (FTNT), up 10%... Flextronics (FLEX), up 10%... Skyworks (SWKS), up 5.7%... Seagate Technology (STX), up 4.9%.. Microsoft (MSFT), up 4.6%. ALSO HIGHER: Inovio Pharmaceuticals (INO), up 8.1% after CEO says Zika vaccine could enter human testing this year... J.C. Penney (JCP), up 2.1% after being upgraded to Neutral from Underperform at Credit Suisse... BRF S.A. (BRFS), up 3.1% after being upgraded to Buy from Hold at Deutsche Bank... Axiall (AXLL), up 83.4% after rejecting $20 per share acquisition proposal from Westlake Chemical (WLK)... Energous (WATT), up 12% after Bloomberg reported that Apple (AAPL) is working with partners in the U.S. and Asia to develop new wireless charging technology. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 10.1%... Electronic Arts (EA), down 6.2%... AbbVie (ABBV), down 4%... American Airlines (AAL), down 1.3%. ALSO LOWER: Gilead Sciences (GILD), down 5.5% after CEO John Martin to assume role of executive chairman and COO John Milligan will be promoted to CEO.
08:14 EDTGILDPiper Jaffray holds an analyst/industry conference call to discuss Gilead
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08:01 EDTGILDGilead chairman, CEO John C. Martin to assume role of executive chairman
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January 28, 2016
19:09 EDTQSIIOn The Fly: After Hours Movers
UP AFTER EARNINGS: Gigamon (GIMO), up 15.2%... QLogic (QLGC), up 11%... Fortinet (FTNT), up 9.2%... ShoreTel (SHOR), up 5.7%... Skyworks (SWKS), up 3.6%... Flextronics (FLEX), up 4.6%... Microsoft (MSFT), up 3.6%... Proofpoint (PFPT), up 3.1%. ALSO HIGHER: Palo Alto Networks (PANW) is up 1.1% and FireEye (FEYE) is up 1.6% after Fortinet reported quarterly results. DOWN AFTER EARNINGS: Amazon.com (AMZN), down 13.2%... Synaptics (SYNA), down 3.8%... Electronic Arts (EA), down 8%... Quality Systems (QSII), down 9%... Visa (V), down 1.2%. ALSO LOWER: Facebook (FB) is down 1.2%, Netflix (NFLX) is down 2.7%, and Alphabet (GOOG, GOOGL) is down 1.5% and 1.7%, respectively, after Amazon reported quarterly results.
16:17 EDTEXELExelixis announces EMA acceptance of MAA for cabozantinib
Exelixis announced the European Medicines Agency, or EMA, has accepted for review the Marketing Authorization Application, or MAA, for cabozantinib as a treatment for patients with advanced renal cell carcinoma, or RCC, who have received one prior therapy. The completion of the MAA validation process confirms that the submission is sufficient to permit a substantive review for marketing authorization in the European Union. The EMA's Committee for Medicinal Products for Human Use, or CHMP, previously granted accelerated assessment to cabozantinib for advanced RCC. As a result, the MAA will be eligible for a 150-day review, versus the standard 210 days.
16:03 EDTQSIIQuality Systems reports Q3 adjusted EPS 16c, consensus 15c
Reports Q3 revenue $116.4M, consensus $125.5M.
09:19 EDTEXELOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Facebook (FB), up 13.9%... Under Armour (UA), up 14.6%... MicroStrategy (MSTR), up 8.9%... Harley-Davidson (HOG), up 8%... Paypal (PYPL), up 6%... Mellanox (MLNX), up 7.9%... Cirrus Logic (CRUS), up 6.2%... Alibaba (BABA), up 4.5%. ALSO HIGHER: Neos Therapeutics (NEOS), up 61.4% after the FDA approved Adzenys XR-ODT for the treatment of ADHD... Exelixis (EXEL), up 4.7% after the U.S. FDA determined the company's New Drug Application for cabozantinib is sufficiently complete... Kinder Morgan (KMI), up 6.7% after being upgraded at Credit Suisse and Stifel. DOWN AFTER EARNINGS: OSI Systems (OSIS), down 21.3%... ServiceNow (NOW), down 22.3%... eBay (EBAY), down 11.5%... InvenSense (INVN), down 10.5%... Juniper Networks (JNPR), down 9.3%... Hologic (HOLX), down 4.4%... Abbott Laboratories (ABT), down 3.6%... Potash (POT), down 2.1%... Qualcomm (QCOM), down 3.6%.
08:03 EDTEXELExelixis: FDA deems NDA for cabozantinib as 'sufficiently complete'
Exelixis announced that the U.S. FDA has determined the company's New Drug Application for cabozantinib as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy to be sufficiently complete to permit a substantive review. The NDA will be considered officially filed 60 days from the date of the completion of the submission, or February 20, 2016. The FDA granted Priority Review to the filing and assigned a Prescription Drug User Fee Act action date of June 22, 2016. "With FDA granting Priority Review to our application, Exelixis is one step closer to offering physicians cabozantinib as an important new therapeutic option for their patients with advanced renal cell carcinoma," said Michael M. Morrissey, Ph.D., president and CEO of Exelixis. "While we work closely with the FDA during the review process, Exelixis will continue to execute on our commercial plans, including our commitment to be ready for a potential launch by April 1st of this year." A Priority Review designation is granted by the FDA for drugs that, if approved, would be significant improvements in the treatment, prevention or diagnosis of a disease. Previously, the FDA granted cabozantinib Breakthrough Therapy designation and Fast Track designation for the compound's proposed RCC indication. The NDA is based on the results of METEOR, a phase 3 pivotal trial comparing cabozantinib to everolimus in patients with advanced RCC who experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor. In July 2015, Exelixis announced top-line results demonstrating that the trial had met its primary endpoint of improving progression-free survival; compared with everolimus, cabozantinib was associated with a 42% reduction in the rate of disease progression or death. These data were later presented at the European Cancer Congress in September 2015 and concurrently published in The New England Journal of Medicine.
January 27, 2016
11:07 EDTGILDGilead sinks as Attorney General probes pricing strategy
Shares of drugmaker Gilead (GILD) are underperforming after Massachusetts Attorney General Maura Healey warned that her office may bring an unfair commercial conduct complaint against it related to the pricing for its Hepatitis C virus treatments Sovaldi and Harvoni. UNFAIR PRICING: Healey, in a letter addressed to Gilead CEO John Martin dated January 22 that has just been made public, said that her office is considering whether Gilead's pricing strategy for Sovaldi and Harvoni may constitute an "unfair trade practice" in violation of Massachusetts law. "Because Gilead's drugs offer a cure for a serious and life-threatening infectious disease, pricing the treatment in a manner that effectively allows HCV to continue spreading through vulnerable populations, as opposed to eradicating the disease altogether, results in massive public harm," Healey stated in her letter to Martin. Healey, who urged Gilead to adjust its pricing strategy, noted that the company has invoked the high cost and risk associated with research and development as a justification for its prices, but she said that Gilead quickly recouped its outlay to acquire Pharmasset by selling "$12.4B worth of HCV medication in the first year alone" after its deal. The AG, who said that Sovaldi costs $1,000 per pill in the U.S. but only $10 per pill in Egypt and about $4 per pill in India, contends that American taxpayers "have been footing the bill for Gilead's record profits." FREQUENT TARGET: The pricing of Gilead's hep C treatments have been the focus of significant criticism and political rhetoric in the past. In December, Senate Finance Committee Ranking Member Ron Wyden and senior committee member Chuck Grassley released the results of an 18-month investigation into the pricing and marketing of Sovaldi and Harvoni. The company "pursued a marketing strategy and final wholesale price of Sovaldi - $1,000 per pill, or $84,000 for a single course of treatment - that it believed would maximize revenue," and "fostering broad, affordable access was not a key consideration in the process of setting the wholesale prices," the senators wrote. Members of the Affordable Drug Pricing Task Force, who held a press conference last November to announce "meaningful action" to combat the "skyrocketing" costs of pharmaceuticals, specifically took aim at Sovaldi. During her campaigning efforts, presidential candidate Hillary Clinton has repeatedly decried the "outrageous" prices of specialty drugs. OTHERS TO WATCH: AbbVie (ABBV), Merck (MRK) and Johnson & Johnson (JNJ) also market or are at work on therapies for hepatitis C. PRICE ACTION: In morning trading, Gilead slid 2% to $90.35.
10:38 EDTGILDGilead trades near session lows
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08:52 EDTGILDMassachusetts AG warns Gilead hep C drug prices may be unfair, Boston Globe says
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January 26, 2016
15:53 EDTGILDGilead mentioned positively ahead of earnings at Barclays
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09:55 EDTQSIILeerink /healthcare tech analysts hold analyst/industry conference call
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January 25, 2016
10:00 EDTQSIIOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: American Express (AXP) upgraded to Perform from Underperform at Oppenheimer... BankMutual (BKMU) upgraded to Outperform from Market Perform at Hovde Group... Black Hills (BKH) upgraded on acquisition at BMO Capital... Bruker (BRKR) upgraded to Buy from Hold at Cantor... Cedar Fair (FUN) upgraded to Conviction Buy from Buy at Goldman... Charles Schwab (SCHW) upgraded to Buy from Neutral at Nomura... Corporate Office Properties (OFC) upgraded to Buy from Neutral at Mizuho... Entegris (ENTG) upgraded on valuation, outlook at Pacific Crest... First Financial upgraded to Outperform from Market Perform at Keefe Bruyette... Goldman Sachs (GS) upgraded to Buy from Neutral at Nomura... Graphic Packaging (GPK) upgraded to Outperform from Neutral at Macquarie... Home Depot (HD) upgraded to Buy from Hold at Deutsche Bank... Intel (INTC) upgraded to Outperform from Neutral at Macquarie... J.B. Hunt (JBHT) upgraded to Buy from Hold at BB&T... Magna (MGA) upgraded to Buy from Neutral at Citi... Masco (MAS) upgraded to Buy from Hold at Evercore ISI... Mattel (MAT) upgraded to Conviction Buy from Buy at Goldman... O'Reilly Automotive (ORLY) upgraded to Buy from Hold at Deutsche Bank... PACCAR (PCAR) upgraded to Buy from Neutral at Citi... People's United (PBCT) upgraded to Neutral from Underweight at Piper Jaffray... Quality Systems (QSII) upgraded to Overweight from Neutral at Piper Jaffray... RadiSys (RSYS) upgraded to Buy from Hold at Needham... Standard Motor (SMP) upgraded to Buy from Neutral at CL King... Swedbank (SWDBY) upgraded to Hold from Underperform at Jefferies... Toll Brothers (TOL) upgraded to Strong Buy from Outperform at Raymond James... Voyager Therapeutics (VYGR) upgraded to Neutral from Sell at Chardan... Yahoo (YHOO) upgraded to Buy from Hold at Pivotal Research.
05:37 EDTQSIIQuality Systems upgraded to Overweight from Neutral at Piper Jaffray
Piper Jaffray analyst Sean Wieland upgraded Quality Systems to Overweight saying changes made by CEO Rusty Frantz will stabilize the business in 2016 and drive organic revenue growth and operating leverage in 2017. Wieland upped his price target for the shares to $23 from $13.
January 22, 2016
09:34 EDTGILDActive equity options trading on open
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