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July 24, 2014
05:37 EDTGILDGilead announces new agreement with MPP
Gilead Sciences announced a new agreement with the Medicines Patent Pool, or MPP, to expand access to Gileadís investigational drug tenofovir alafenamide, or TAF, for HIV and hepatitis B, contingent on the medicineís U.S. regulatory approval. Under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries.
News For GILD From The Last 14 Days
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October 6, 2015
13:32 EDTGILDBiotechs plummet with TPP seen as industry negative
Biotechs are falling intraday after reports that the Trans-Pacific Partnership, or TPP, has language that the exclusivity period for bioligics, or drugs derived from a biological sources, would be eight years, less than the twelve years it is currently in the United States. WHAT'S NOTABLE: In the U.S., biologics are protected from competition by follow-on products for twelve years from the time they are first granted marketing approval by the U.S. Food and Drug Administration, a protection that is distinct from patent protection. Recent reports on the TPP suggest that the protection will last five years with an additional safety monitoring period of up to three years before a biosimilar can be registered, which would effectively be an eight year exclusivity period. ANALYST REACTION: Piper Jaffray analyst Joshua Schimmer, however, said the development is a "step forward," especially since it does not overrule the 12 years' exclusivity for the drugs in the U.S. While the sector asked for twelve years' exclusivity to match the U.S., eight years is a "reasonable compromise," the analyst argued. His top picks were Alexion (ALXN), Celgene (CELG), and Amgen (AMGN) in the large-cap space, GW Pharmaceuticals (GWPH) and bluebird bio (BLUE) among mid-caps, and Flex Pharma (FLKS), Lion Biotechnologies (LBIO), Otonomy (OTIC), and Ignyta (RXDX) in the small-cap sector. Further, Schimmer stated that more names look "increasingly compelling" amid the selloff. NOTABLE DECLINERS: Alexion is lower by 2.53%, Celgene is down 4.32%, Amgen is declining 1.91%, Biogen (BIIB) is down 3.4%, and Gilead Sciences (GILD) is falling 2.22%. STOCKS TO WATCH: Other publicly traded companies in the pharmaceutical space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).
October 5, 2015
10:02 EDTGILDBofa/Merrill healthcare analysts hold an analyst/industry conference call
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06:13 EDTGILDContraVir reports data shows CMX157 more potent against HBV than Gilead Viread
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October 2, 2015
18:21 EDTGILDGilead announces FDA approval of Letairis
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11:18 EDTGILDMorgan Stanley downgrades select pharma stocks amid drug price scrutiny
Morgan Stanley downgraded several stocks in the pharmaceutical sector, dropping drugmakers Valeant (VRX), Gilead (GILD) and Regeneron (REGN) to Equal Weight from Overweight. The firm also downgraded specialty pharmacy Diplomat Pharmacy (DPLO) to Equal Weight and cut its rating on drug distributor AmerisourceBergen (ABC) to Underweight, the firm's equivalent of a sell rating. WHAT'S NEW: Democrats' scrutiny of high drug prices may continue, warned Morgan Stanley analyst David Risinger. As a result, it is hard to predict when Valeant, which generated 14% of its Q2 sales rise from price increases, will see its P/E multiple rise, Risinger believes. The company's lower multiple will hinder its ability to conduct M&A and swap or issue equity, according to Risinger, who set a $200 price target on the stock. Morgan Stanley analyst Matthew Harrison downgraded Gilead, noting that U.S. hepatitis C volume growth has dropped in the last few months. Although Harrison thinks that the U.S. hepatitis C market is still strong, he believes that the data could cause the Street to become concerned about Gilead's fourth quarter and 2016 outlook. He set a $127 price target on the shares. Harrison also downgraded Regeneron, stating his belief that two other drug makers, Alexion (ALXN) and Vertex (VRTX), have stronger near-term appreciation potential. He added that Regeneron has a number of potential negative catalysts, including drug pricing concerns and his belief, based on physician feedback, that the launch of the company's cholesterol drug, Praluent, could miss expectations. He set a $593 price target on the shares. AmerisourceBergen, which provides pharmaceutical sourcing and distribution service to healthcare providers, is the most levered to branded price inflation and that attribute could weigh on the shares, said Risinger, who cut his price target to $93 from $120 on the stock. The uncertain outlook for drug prices could keep the stock range-bound, added the analyst. PRICE ACTION: In morning trading, Valeant dropped 2.3% to $175.50, Gilead declined 1% to $97.26, Regeneron was flat near to $472 per share and AmerisourceBergen slid 1.3% to $93.25.
10:55 EDTGILDStocks with call strike movement; FB GILD
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10:00 EDTGILDOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: AGCO (AGCO) downgraded to Underperform from Neutral at BofA/Merrill... AIG (AIG) downgraded to Market Perform with $63 target at FBR Capital... AmerisourceBergen (ABC) downgraded to Underweight from Equal Weight at Morgan Stanley... Astoria Financial (AF) downgraded to Hold from Buy at Sandler O'Neill... Capstone Turbine (CPST) downgraded to Hold from Buy at Craig-Hallum... Diplomat Pharmacy (DPLO) downgraded to Equal Weight from Overweight at Morgan Stanley... Fifth Third (FITB) downgraded to Neutral from Buy at Goldman... Gilead (GILD) downgraded to Equal Weight from Overweight at Morgan Stanley... Henkel (HENKY) downgraded to Neutral from Outperform at Exane BNP Paribas... Horsehead Holding (ZINC) downgraded to Perform from Outperform at Oppenheimer... LPL Financial (LPLA) downgraded to Sell from Neutral at UBS... MYR Group (MYRG) downgraded on electricity outlook at BB&T... Orion Marine (ORN) downgraded on reduced dredging awards at BB&T... QTS Realty Trust (QTS) downgraded to Hold from Buy at Stifel... Quanta Services (PWR) downgraded to Hold from Buy at BB&T... Regeneron (REGN) downgraded to Equal Weight from Overweight at Morgan Stanley... Ryanair (RYAAY) downgraded to Hold from Buy at HSBC... T. Rowe Price (TROW) downgraded to Neutral from Buy at UBS... Telekom Austria (TKAGY) downgraded to Hold from Buy at HSBC... Valeant (VRX) downgraded to Equal Weight from Overweight at Morgan Stanley.
09:36 EDTGILDActive equity options trading on open
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09:13 EDTGILDOn The Fly: Pre-market Movers
HIGHER: Wynn Resorts (WYNN), up 6.7% after reports indicate Chinese government may enact new policies to support Macau's economy. Shares of fellow Macau casino operators Las Vegas Sands (LVS) and MGM Resorts (MGM) are also higher in pre-market trading. UP AFTER EARNINGS: Micron (MU), up 3.3%... CalAmp (CAMP), up 9%. DOWN AFTER EARNINGS: Progress Software (PRGS), down 14.5%. ALSO LOWER: Valeant (VRX), down 4.5% after being downgraded to Equal Weight from Overweight at Morgan Stanley... Keurig Green Mountain (GMCR), down 3.4% after disclosing that its president of U.S. sales and marketing resigned... AIG (AIG), down 3% after being downgraded to Market Perform from Outperform at FBR Capital... Gilead (GILD), down 2% following a downgrade to Equal Weight at Morgan Stanley.
07:06 EDTGILDGilead downgraded to Equal Weight from Overweight at Morgan Stanley
Morgan Stanley downgraded Gilead to Equal Weight and maintained its $127 price target. Matthew Harrison downgraded shares based on relative valuation and said a single acquisition would not be enough to re-rate shares.
October 1, 2015
09:35 EDTGILDActive equity options trading on open
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September 30, 2015
09:59 EDTGILDActive equity options trading on open
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September 29, 2015
16:00 EDTGILDOptions Update; September 29, 2015
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11:11 EDTGILDStocks with call strike movement; CELG GILD
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09:35 EDTGILDActive equity options trading on open
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September 28, 2015
16:00 EDTGILDOptions Update; September 28, 2015
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15:22 EDTGILDGilead volatility at 52-week high
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09:36 EDTGILD Active equity options trading on open
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September 25, 2015
16:35 EDTGILDStocks end week lower as biotechs sink, Volkswagen crashes
Stocks ended the week lower after concerns about drug prices were reignited, sinking biotech stocks, an emissions scandal engulfed Volkswagen (VLKAY), dragging down shares of automakers and their suppliers, and Caterpillar (CAT) announced that it may eliminate as many as 10,000 jobs in the next three years as commodity prices continue to slump. MACRO NEWS: Following the Federal Reserve's decision last week to wait before raising rates, the central bank made a concerted effort to give the market more clarity this week. Over last weekend, three Federal Reserve officials - San Francisco Fed President John Williams, St. Louis Fed President James Bullard and Richmond Fed President Jeffrey Lacker - all argued that an interest-rate increase is still warranted this year. Then, on Thursday night, Fed Chair Janet Yellen said during a speech at UMass Amherst that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago... In the U.S., Markit's flash manufacturing purchasing manager's index was flat at 53.0 in September, which was slightly better than the expectation for it to dip to 52.8. Durable goods orders for August declined 2.0%, versus expectations for a drop of 2.3%. When transportation items were removed, the core reading was breakeven, versus expectations for a rise of 0.1%. The third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... The Asian Development Bank cut its growth forecast for the region, citing a weaker outlook for China and India and a delayed recovery in the world's advanced economies. The bank now sees the Chinese economy growing 6.8% this year and 6.7% next year, down from its previous forecasts of 7.2% and 7%, respectively. Markit's flash manufacturing PMI for China fell to 47.0 in September from 47.3 last month. Meanwhile, Japanese Prime Minister Shinzo Abe unveiled new economic targets, including a goal for a 20% increase in the target size of the Japanese economy to 600T yen, though he gave no timeframe for achieving this aspiration... In Europe, Markit's composite PMI for the eurozone came in at 53.9 in the first look for September, down from 54.3 in August and below expectations for a reading of 54.1. COMPANY NEWS: Biotech stocks declined after privately-held Turing Pharmaceuticals made headlines by enacting a 5,000% price increase on its treatment for toxoplasmosis, reigniting a debate around drug prices that previously embroiled costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni. Presidential candidate Hillary Clinton sent the debate to center stage by criticizing the "outrageous" prices of specialty drugs and laying out a plan to tackle "price gouging" in the specialty drug market. The NASDAQ Biotechnology index fell roughly xxx% for the week amid the attention paid to Turing's drug and Clinton's response... Volkswagen (VLKAY) shares trading in New York fell sharply to begin the week and ended the week far from where they'd been last Friday before the EPA said it found manipulations that violate U.S. environmental standards while testing certain of the automaker's diesel cars. The EPA said Volkswagen may face civil penalties of $37,500 for each vehicle not in compliance with federal clean air rules, which could total as much as $18B, according to Reuters. In the wake of the scandal, Chief Executive Officer Martin Winterkorn resigned, with the company's supervisory board subsequently praising the decision and selecting Matthias Mueller, the former head of Porsche (POAHY), as Winterkorn's successor as the company's new CEO... Caterpillar (CAT) shares dropped after the heavy machinery maker announced plans for job cuts and lowered its revenue guidance for this year and next. Caterpillar said that it would lay off 4,000-5,000 of its employees between now and the end of 2016 and could lay off up to 10,000 employees by 2018. Caterpillar cut its fiscal year 2015 revenue forecast by $1B and said its sees its fiscal year 2016 revenue to be 5% below this year, adding that it expects revenue declines in all three large segments next year... Online and mobile deal provider Groupon (GRPN) said it plans to cut 1,100 jobs relating primarily to the company's international operations... Nike jumped after the athletic gear giant reported better than expected earnings and futures orders, prompting numerous price target hikes and at least one upgrade at Street research firms. Among other companies reporting earnings this week, BlackBerry (BBRY), ConAgra (CAG), Carnival (CCL), and CarMax (KMX) fell immediately following their quarterly reports... Apple (AAPL), which has previously been reported to be working on an electric car via its "Project Titan," is speeding up those efforts and setting 2019 as a target to ship its first vehicle, according to The Wall Street Journal... Against the backdrop of China's President Xi Jinping visiting the U.S., Boeing (BA) announced deals to sell 300 planes to three Chinese companies and set up an aircraft factory in in the Asian nation, while Cisco (CSCO) announced a partnership with Chinese server maker Inspur Group... Lloyd Blankfein, Goldman Sachs (GS) Chairman and CEO, disclosed that he was diagnosed with lymphoma. "Fortunately, my form of lymphoma is highly curable and my doctors' and my own expectation is that I will be cured," Blankfein stated in an open letter that was shared by the bank... GoPro (GPRO) finished the week about xxx% lower after Barron's contended in a feature article last weekend that the company's stock could plunge another 30% to $25 as Apple, Sony (SNE) and others pressure the company's "one-hit wonder" products... On the M&A front, Atmel (ATML) agreed to be acquired by German chipmaker Dialog Semiconductor in a deal valued at roughly $4.6B and Starwood Waypoint (SWAY) announced a stock-for-stock merger agreement with Colony American Homes. INDEXES: The Dow lost about 0.43% to close at 16,314.67, the S&P 500 fell about 1.35% to close at 1,931.34, and the Nasdaq declined about 2.89% to close at 4,686.50.
07:34 EDTGILDGilead says CHMP adopts poistive opinion for single tablet regimen Genvoya
Gilead Sciences announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion on the company's Marketing Authorization Application for the investigational, once-daily single tablet regimen Genvoya for the treatment of HIV-1 infection. The data submitted in the MAA support the use of the regimen among adult and adolescent treatment-naive individuals, virologically suppressed adults who switch regimens and adults with mild-to-moderate renal impairment. The CHMP's recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use in the 28 countries of the European Union. If authorized, Genvoya would be Gilead's first single tablet regimen to contain TAF. The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies in which the regimen met its primary objective of non-inferiority compared to Gilead's Stribild among treatment-naive adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.

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