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Stock Market & Financial Investment News

News Breaks
March 5, 2014
13:02 EDTMRK, ARWR, BMY, NVS, RHHBYAnalyst: Arrowhead Research could be in early stages of major run, Barron's says
RBC analyst Michael Yee believes Arrowhead Research is in the early innings of a potentially major run, according to Barron's. Yee cites the company's promising lead drug for Hep B, its RNAi platform technology, and the fact that it could partner with larger firms such as Roche (RHHBY), Bristol Myers (BMY), Merck (MRK), and Novartis (NVS).Reference Link
News For ARWR;RHHBY;BMY;MRK;NVS From The Last 14 Days
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July 22, 2015
06:05 EDTMRKMerck, Ablynx expand immuno-oncology collaboration
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July 21, 2015
14:03 EDTBMYBristol-Myers: Data from Phase IIa study support further evaluation of BMS955176
Bristol-Myers Squibb announced additional Phase IIa proof-of-concept data for BMS-955176, a novel investigational agent designed to prevent the maturation of HIV-1. The study findings, which are being presented in a late-breaking oral presentation at the 8th IAS Conference on HIV Pathogenesis, Treatment and Prevention in Vancouver, confirmed the antiretroviral activity of BMS-955176 when administered with atazanavir and support further development of the second-generation HIV-1 maturation inhibitor. BMS-955176 is designed to inhibit one of the last steps of the HIV-1 viral lifecycle, resulting in the release of immature non-infectious HIV-1 particles. As part of a multi-part proof-of-concept study, a two-drug combination of BMS-955176 plus atazanavir had a maximum median change in HIV-1 RNA of -2.23 log10 c/mL from baseline through study discharge. The standard of care control of atazanavir 300 mg and ritonavir 100 mg plus tenofovir disoproxyl fumarate 300 mg plus emtricitabine 200 mg in a fixed dose combination had a maximum median change in HIV-1 RNA of -2.39 log10 c/mL from baseline through study discharge. In addition, a lower dose of BMS-955176 plus atazanavir and ritonavir had a similar maximum median change in HIV-1 RNA of -2.20 log10 c/mL. Length of therapy for all treatment groups was 28 days. Study endpoints included change in HIV-1 RNA from baseline to Day 28 and from baseline to the end of the study and safety. Data from Part A and Part B of the Phase IIa proof-of-concept study support the further evaluation of BMS-955176 in novel treatment regimens such as nucleos(t)ide- and booster-sparing regimens to address key unmet needs for HIV-1 treatment-experienced patients. Two Phase IIb studies have started in 2015: a traditional dose-finding study in treatment-naive patients and a second Phase IIb study to evaluate a nucleos(t)ide- and booster-sparing regimen in treatment-experienced patients.
11:49 EDTNVSNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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09:02 EDTBMYBristol-Myers Squibb receives FDA breakthrough designation for HIV-1 inhibitor
Bristol-Myers Squibb announced that the FDA has granted Breakthrough Therapy Designation to the investigational compound BMS-663068 when used in combination with other antiretroviral, or ARV, agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors’ activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus’ initial interaction with immune cells entirely, and thus blocks its entry into the cell.
07:05 EDTRHHBYOphthotech names Shima as Chief Scientific Officer, Bjarke as CCO
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05:20 EDTNVSNovartis backs FY15 revenue guidance of up mid-single digit
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05:17 EDTNVSNovartis reports Q2 core EPS $1.27, consensus $1.24
Reports Q2 revenue $12.7B, consensus $12.44B. Further strengthening of USD impacted sales by -11% and core operating income by -13%. Growth Products, an indicator of the rejuvenation of the portfolio, contributed 35% of continuing operations net sales in Q2, and were up 24%. In Pharmaceuticals, Growth Products contributed 44% of division net sales in the quarter, and sales for these products were up 38%.
July 20, 2015
12:09 EDTBMYBristol-Myers says Nivolumab BMS approved in EU for SQ NSCLC
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12:08 EDTBMYOn The Fly: Top stock stories at midday
Stocks on Wall Street were slightly higher at midday in the first trading day of a week that will be light on domestic economic data but heavy on earnings reports. Investors will be receiving profit reports from about 25% of the companies on the S&P 500 this week, making this the highest volume earnings week of this season. ECONOMIC EVENTS: In the U.S., no major data was released. In Europe, Greece reopened its banks three weeks after closing as the country worked out another bailout agreement. The country announced it has started the process of paying off its creditors, including the European Central Bank and the International Monetary Fund, with a bridge loan it just received. COMPANY NEWS: Lockheed Martin (LMT) agreed to buy the Sikorsky Aircraft business from United Technologies (UTX) for $9B, noting the price is "effectively reduced" to $7.1B after taking into account tax benefits resulting from the transaction. Shares of Lockheed, which also reported better than expected second quarter results and increased its fiscal year guidance, gained nearly 2% after the Sikorsky announcement and saying it will conduct a strategic review of its government IT infrastructure services business and technical services business... Shares of Morgan Stanley (MS) shares were little changed near noon after the bank reported earnings and revenue, excluding certain adjustments, that topped analysts' consensus forecasts... SunEdison (SUNE) announced a deal to acquire Vivint Solar (VSLR) for approximately $2.2B, payable in a combination of cash, shares of SunEdison common stock and SunEdison convertible notes. In connection with the proposed acquisition of Vivint Solar, SunEdison has entered into a definitive purchase agreement with a subsidiary of TerraForm Power (TERP) which, concurrently with the completion of SunEdison's acquisition of Vivint, will acquire Vivint Solar's rooftop solar portfolio, consisting of 523 MW expected to be installed by year-end 2015, for $922M in cash. Shares of Vivint rose 44% following the announcement, while SunEdison's stock gained 4% and TerraForm dropped 3%. Fellow residential solar installer SolarCity (SCTY), which is backed by Tesla's (TSLA) Elon Musk, rose 7% following the deal in the space. MAJOR MOVERS: Among the notable gainers was Exelixis (EXEL), which rallied 43% after the company reported that a study of cabozantinib in metastatic renal cell carcinoma met its primary endpoint of significant improvement in progression-free survival. The shares were indicated to rise even more in early pre-market trading, but lost some of their gains after Bristol-Myers (BMY) announced that its Opdivo study was stopped early after showing superior overall survival in a Phase 3 study of previously treated patients with advanced or metastatic renal cell carcinoma. Bristol-Myers rose a bit less than 1% to trade near $70 per share after its own announcement. Also higher was PayPal (PYPL), which gained more than 5.5% in its first day of trading after being spun out of eBay (EBAY). Meanwhile, eBay shares rose over 2%. Cal-Maine Foods (CALM) dropped 8% after posting lower than expected sales and profits in its fourth quarter and warning that while it should have an adequate supply of its primary feed ingredients, the company expects that prices will be "volatile" in the year ahead. Also lower were shares of several gold miners, including Barrick Gold (ABX) and Newmont Mining (NEM), which each fell about 11%, as gold prices declined about 2% near midday. INDEXES: Near midday, the Dow was up 31.66, or 0.18%, to 18,118.11, the Nasdaq was up 9.81, or 0.19%, to 5,219.96, and the S&P 500 was up 2.82, or 0.13%, to 2,129.46.
08:28 EDTBMYExelixis off highs, but still up 34% after Bristol-Myers data
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08:25 EDTNVSNovartis management to meet with JPMorgan
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08:05 EDTBMYBristol-Myers says Phase III study evaluating Opdivo stopped early
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07:33 EDTRHHBY, BMYInternational AIDS Society to hold a conference
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07:32 EDTNVSAlzheimer's Association to hold a conference
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05:13 EDTRHHBYRoche expands HIV Global Access Program
Roche announced an expansion to the HIV Global Access Program to include early infant HIV diagnostic testing for low and middle income countries. Roche, in partnership with the Joint United Nations Programme on HIV/AIDS, or UNAIDS, the Clinton Health Access Initiative, or CHAI, UNITAID, the U.S. President's Emergency Plan For AIDS Relief, or PEPFAR, and the Global Fund to fight AIDS, TB and Malaria, is committed to working with the Diagnostics Access Initiative by providing state-of-the-art solutions to achieve the 90-90-90 goal set forth by UNAIDS. Announced in 2014, the HIV Global Access Program is Roche's most recent addition to the AmpliCare Initiative, which launched in 2002 in South Africa.
July 16, 2015
09:22 EDTBMYBristol-Myers says EU approves Evotaz for treatment of HIV-1 infection in adults
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09:01 EDTBMYuniQure has reached compelling entry point, says Roth Capital
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July 15, 2015
08:32 EDTBMYBristol-Myers Squibb, MUSC announce translational research collaboration
The Medical University of South Carolina, or MUSC, and Bristol-Myers Squibb (BMY) announced that they have entered into a translational research collaboration focused on fibrotic diseases, including scleroderma, renal fibrosis and idiopathic pulmonary fibrosis. The agreement includes studies designed to improve the mechanistic understanding of fibrosis, explore patient segmentation based on disease characteristics and/or biomarker approaches and predictors of disease progression.
07:58 EDTNVSAnalysts break down impact of $7.2B Receptos buyout
After Celgene (CELG) announced last night that the company has agreed to acquire Receptos (RCPT) for $232 per share in cash, or a total of about $7.2B net of cash acquired, research firms have chimed in with their opinions on how the proposed deal may impact others in the biotech space. Receptos key asset is Ozanimod, which is being studied in Phase III trials for relapsing multiple sclerosis and ulcerative colitis. DERIVATIVE CALLS: Piper Jaffray analyst Edward Tenthoff told investors that he views Celgene's deal for Receptos as good for Arena Pharmaceuticals (ARNA). The analyst notes that Arena's APD334 is already showing dose-dependent decreases in circulating lymphocyte counts and that the company will initiate Phase II studies in ulcerative colitis and Crohn's disease this year. Tenthoff reiterates an Overweight rating and $7.50 price target on Arena, which has a market capitalization around $1B and closed yesterday up 8c to $4.47. In its own note to investors this morning, Nomura said Celgene's deal could put downward pressure on Biogen's (BIIB) long-term multiple sclerosis estimates. Nomura's M. Ian Somaiya contended that one-year Phase II efficacy data for Ozanimod looked as good as Novartis’s (NVS) Gilenya and Biogen's Tecfidera’s Phase III at year 2. Somaiya also wondered if rival Gilead (GILD) could be "looking for something bigger" than Receptos for its own deal, telling investors that the firm views Incyte (INCY) as Gilead's most likely takeout target. Incyte's shares closed up $4.46 at $117.46 yesterday, giving the company a market cap of about $20B. RIVAL BID?: Wedbush analyst Liana Moussatos believes another bidder may seek to acquire Receptos, noting that she previously estimated Receptos could be valued at $348 per share, or about $10.9B, in a buyout. Moussatos noted that Celgene said it expects annual peak sales for Ozanimod to reach about $4B-$6B for RMS and UC, making its acquisition price of $7.2BN only a bit more than about 1X peak sales without accounting for other possible indications or the rest of its pipeline. Moussatos told investors she sees "plenty" of potential upside to justify a rival bidder stepping in and reiterated the firm's Outperform rating on Receptos shares. PRICE ACTION: In pre-market trading, Receptos rose 10% to $228.61 while Gilead gained 1.4% to about $119 per share.
July 14, 2015
06:04 EDTRHHBYRoche says atezolizumab met primary endpoint in IMvigor 210 trial
Roche announced that in the IMvigor 210 study, the investigational cancer immunotherapy atezolizumab shrank tumors -- objective response rate, ORR, the primary end point of this Phase II study -- in people with locally advanced or metastatic urothelial bladder cancer who had progressed on initial treatment. High amounts of PD-L1 expression by a person’s cancer correlated with increased response to the medicine. Adverse events were consistent with what has been previously observed for atezolizumab. Sandra Horning, M.D., chief medical officer and head of Global Product Development, said, “We plan to present results at an upcoming medical meeting and will discuss next steps with health authorities to bring a new treatment option to patients as soon as possible.” Last year, the U.S. FDA granted Breakthrough Therapy Designation for atezolizumab in people whose metastatic bladder cancer expressed PD-L1. This designation is designed to expedite the development and review of medicines intended to treat serious diseases. In addition to the IMvigor 210 study, Roche has an ongoing randomised Phase III study, IMvigor 211, comparing atezolizumab with standard-of-care chemotherapy in people who have relapsed UBC, and a planned Phase III study, IMvigor 010, that will evaluate atezolizumab compared with observation in people with early-stage muscle-invasive bladder cancer who are selected for PD-L1 expression and are at risk for recurrence.
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