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February 5, 2013
11:25 EDTACHN, ACHN, IDIX, IDIX, BMY, BMY, MRK, MRK, RHHBY, RHHBY, GILD, GILD, VRTX, VRTXLazard's biotech analyst research team holds an analyst/industry conference call
Biotech Analyst Research Team discusses the HCV treatment outlook on an Analyst/Industry conference call. Relevant companies BMY, MRK, RHHBY, GILD, VRTX, ACHN and IDIX may be discussed on the Analyst/Industry conference call to be held on February 5 at 12 pm.
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September 27, 2015
17:02 EDTRHHBYNewLink Genetics reports early Phase 1a data on GDC-0919
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16:47 EDTMRKMerck reports Phase 1b data on Keytruda for two gastrointestinal cancers
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16:42 EDTRHHBYRoche present Phase 2 results on atezolizumab for urothelial cancer
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16:40 EDTRHHBYRoche reports results from two Phase 2 studies on atezolizumab
Genentech, a member of the Roche Group, announced results from two Phase 2 studies that evaluated the investigational cancer immunotherapy atezolizumab -- or anti-PDL1; MPDL3280A -- in people with advanced non-small cell lung cancer. In the randomized Phase 2 study POPLAR, atezolizumab met its primary endpoint and showed a statistically significant survival benefit compared to chemotherapy in people with recurrent NSCLC whose tumors expressed medium and high levels of PD-L1, which corresponded with people living 7.7 months longer than people who received docetaxel chemotherapy. A separate, single-arm Phase 2 study, BIRCH, met its primary endpoint and showed that atezolizumab shrank tumors in up to 27% of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1. Median survival had not yet been reached. In both studies of atezolizumab, adverse events were consistent with those observed in previous studies. "We plan to submit these results to global health authorities to bring this potential new option to people as soon as possible," said Chief Medical Officer Sandra Horning.
14:58 EDTMRKMerck announces Phase 1b data on Keytruda for nasopharyngeal cancer
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September 25, 2015
18:06 EDTBMYBristol-Myers says Opdivo demonstrates superior survival in Phase 3 trial
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17:08 EDTBMYBristol-Myers' Opdivo approved by Health Canada for metastatic melanoma
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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.
16:17 EDTVRTXOn The Fly: Top stock stories for Friday
Stocks opened with sharp gains the day after Fed Chair Janet Yellen gave some clarity to the market by suggesting the Fed will most likely raise interest rates by the end of the year. During afternoon trading, the news flow slowed and the volume lightened on the buy side, leaving the sellers with the upper hand. The Nasdaq was the first index to move into negative territory, led by broad weakness in biotech stocks, while the Dow was helped to stay in the green by a big post-earnings move higher in Nike (NKE). The averages limped into the close, leaving the market with an interesting set-up to begin next week. Outside of stock news, it was certainly a headline packed day, as Speaker of the House John Boehner announced that he will resign at the end of October, Chinese President Xi Jinping continued his U.S. visit and Pope Francis addressed the United Nations while spending a second day in New York City. ECONOMIC EVENTS: In the U.S., 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... Federal Reserve Chair Janet Yellen said during a speech at UMass Amherst last night 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. Of note, the Fed chair paused multiple times toward the end of her speech and received medical attention afterward, but returned to her regular schedule later in the evening, with the bank explaining that Yellen was dehydrated after a long day but was otherwise fine. COMPANY NEWS: Nike jumped $10.23, or 8.9%, to $125.02 after Thursday night's report of better than expected earnings and futures orders prompted numerous price target hikes at Street research firms. Additionally, Sterne Agee upgraded Nike to Buy from Neutral, saying it thinks the company is benefiting from its "global grass roots engagement with its customers," which enables it to meet its customers' needs and determine to what extent it can raise prices. The firm, which thinks that the company is continuing to gain share, has a $150 price target on the athletic gear giant... Biotech stocks, which were already having a bad week, ended the week on a down note, as the iShares NASDAQ Biotechnology Index (IBB) fell 4.9%, giving it a weekly decline of about 13%. Among the biggest large-cap losers in the space were Vertex (VRTX), which fell 7%, Regeneron (REGN), which dropped 6% and Celgene (CELG), which slid 4.8%. MAJOR MOVERS: Among the notable gainers was Jabil Circuit (JBL), which advanced $2.38, or 12.2%, to $21.88 after it reported higher than expected earnings and gave guidance for its November quarter that was significantly above expectations. Also higher was Cirrus Logic (CRUS), which gained $3.90, or 14.4%, to $31.03 after tear downs of Apple's (AAPL) iPhone 6S and 6S Plus led analysts to conclude that the chipmaker appears poised to obtain more revenue from the new devices than from the previous generation of the market-leading smartphone. Among the noteworthy losers was Finish Line (FINL), which fell $4.86, or 19.6%, to $19.91 after reporting second quarter revenue that missed expectations and saying it expects adjusted earnings this fiscal year to increase in a low single to mid single digits percentage from last year. Also lower following its earnings report was smartphone and software maker BlackBerry (BBRY), which slid 7.68% to $6.49 after the company posted a second quarter loss that was steeper than analysts expected. BlackBerry also confirmed press reports that it plans to launch a new phone that uses Google's (GOOG) Android operating system instead of its own proprietary BB10 OS. Shares of Aratana Therapeutics (PETX), which dropped $6.81, or 38.97%, to $10.68 after the company said that, based on "mixed clinical and scientific results," it does not believe that canine lymphoma products AT-004 and AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. INDEXES: The Dow rose 113.35, or 0.7%, to 16,314.67, the Nasdaq fell 47.98, or 1.01%, to 4,686.50, and the S&P 500 added/slipped 0.90, or 0.05%, to 1,931.34.
16:17 EDTBMYBristol-Myers announces FDA filing update for Opdivo+Yervoy regimen
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15:31 EDTMRKMerck volatility elevated as shares trend lower
Merck October weekly call option implied volatility is at 39, October is at 34, November is a 29; compared to its 52-week range of 15 to 34, suggesting large price movement after presidential candidate Hilary Clinton announced plans early this week to cap prescription drug prices.
08:15 EDTMRKMerck narrow Keytruda label may not matter as much as thought, says Bernstein
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08:14 EDTBMYJPMorgan reiterates Overweight on Bristol-Myers after physician survey
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08:02 EDTBMYBristol-Myers announces collaboration agreement with Moffitt Cancer Center
Bristol-Myers Squibb Company and Moffitt Cancer Center announced that they have entered into a collaboration agreement as part of Bristol-Myers Squibb's Immuno-Oncology Rare Population Malignancy program in the U.S. The I-O RPM program is a multi-institutional initiative with academic-based cancer centers focused on the clinical investigation of immuno-oncology therapeutics as potential treatment options for patients with high risk, poor prognostic cancers, defined as a rare population malignancy. As part of the I-O RPM program, Bristol-Myers Squibb and Moffitt will conduct a range of early phase clinical studies, including clinical investigations by young investigators to strengthen their development as clinical research scientists.
07:42 EDTRHHBYExelixis: CHMP adopts positive opinion for cobimetinib, vemurafenib combination
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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.
07:22 EDTRHHBY, BMYEuropean Society for Medical Oncology to hold a conference
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07:18 EDTVRTXVertex receives CHMP positive opinions for Orkambi, Kalydeco in EU
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06:24 EDTBMYLeerink says AMAG 'extremely attractive' after McGuff label disclosure
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06:23 EDTRHHBYRoche CEO: Will see growth regardless of setbacks, Reuters reports
Roche Holding's product lineup is so good that the company will see growth regardless of setbacks, Reuters reports, citing an interview with CEO Severn Schwan with Finanz und Wirtschaft. "Roche could have six new active pharmaceutical ingredients approved within two years. We never had this before," Schwan said. Reference Link
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