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Stock Market & Financial Investment News

News Breaks
April 14, 2014
08:15 EDTGILD, BMYBristol-Myers submits NDA for Reyataz-cobicistat combo for HIV-1
Bristol-Myers Squibb (BMY) announced the submission of a new drug application, or NDA, on April 4 to the FDA for a fixed-dose combination of atazanavir sulfate, a protease inhibitor marketed as Reyataz, and cobicistat, an investigational pharmacokinetic enhancer, or boosting agent, that can increase the level of certain HIV-1 medicines in the blood and make them more effective. Bristol-Myers Squibb is seeking approval of the fixed-dose combination tablet for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. If approved, atazanavir sulfate and cobicistat could offer patients living with HIV-1 a single tablet that eliminates the need to take a boosting agent in a separate tablet. Cobicistat is being developed by Gilead Sciences (GILD). Under the terms of a previously announced agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the atazanavir sulfate and cobicistat fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
News For BMY;GILD From The Last 14 Days
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September 1, 2015
07:31 EDTBMYBristol-Myers, AbbVie say FDA accepts BLA for Empliciti for priority review
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07:07 EDTBMYHeat Biologics announces clinical trial combining HS-110, PD-1 in NSCLC
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August 31, 2015
09:11 EDTBMYEuropean Society of Cardiology
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08:32 EDTBMYBristol-Myers reports agreement providing exclusive right to acquire Promedior
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August 30, 2015
19:07 EDTBMYBristol-Myers partners with QIMR Berghofer for immuno-oncology research
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August 28, 2015
07:59 EDTBMYBristol-Myers management to meet with Leerink
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August 27, 2015
10:35 EDTBMYBristol-Myers calls active
Bristol-Myers August weekly 61 and 61.5 calls are active on total call volume of 7K contracts (4K puts). August weekly call option implied volatility is at 35, September is at 34, October is at 28; compared to its 52-week range of 14 to 36. Active call volume suggests traders taking positions for price movement.
07:51 EDTBMYRoche catching up fast to Bristol-Myers in immuno-oncology, says Jefferies
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05:28 EDTBMYAllied-Bristol Life Sciences announces licensing agreement with Yale University
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August 26, 2015
17:06 EDTGILDGilead AMBITION study results published in New England Journal of Medicine
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
August 25, 2015
19:34 EDTGILDExperts tell White House to expand use of Hepatitis C drugs, NYT says
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
August 24, 2015
13:36 EDTGILDBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
09:45 EDTBMYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Bank of America (BAC) upgraded to Outperform from Market Perform at Keefe Bruyette... Bristol-Myers (BMY) upgraded to Neutral from Underweight at Piper Jaffray... Chevron (CVX) upgraded to Neutral from Underperform at BofA/Merrill... Abercrombie & Fitch (ANF) upgraded to Overweight from Neutral... Nike (NKE) upgraded to Outperform from Market Perform at Telsey Advisory... DreamWorks (DWA) upgraded to Buy from Neutral at B. Riley... Caesarstone (CSTE) upgraded to Overweight from Equal Weight at Barclays... TransAlta (TAC) upgraded to Outperform from Market Perform at BMO Capital... Sarepta (SRPT) upgraded to Overweight from Neutral at Piper Jaffray... AutoZone (AZO) upgraded to Buy from Neutral at BofA/Merrill... Royal Dutch Shell (RDS.A) upgraded to Buy from Hold at Jefferies... Allscripts (MDRX) upgraded to Buy from Hold at Argus... China Unicom (CHU) upgraded to Buy from Hold at Jefferies... Ross Stores (ROST) upgraded to Buy from Neutral at Buckingham.
08:16 EDTBMYBristol-Myers, Pfizer to present new data on Eliquis at ESC Congress 2015
Bristol-Myers Squibb Company (BMY) and Pfizer Inc. (PFE) announced that 22 abstracts will be presented at the ESC Congress 2015, to be held August 29 to September 2 in London, United Kingdom. The new data reinforce the Alliance's commitment to the ongoing evaluation of Eliquis in both the nonvalvular atrial fibrillation and venous thromboembolism patient populations. In addition, data from the AEGEAN study evaluating adherence among NVAF patients further extends the Alliance's commitment to patient care.
07:08 EDTBMYBristol-Myers upgraded to Neutral from Underweight at Piper Jaffray
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August 23, 2015
12:35 EDTBMYBiotech firms could see 'billions' in sales from new cancer drugs, Barron's says
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August 20, 2015
16:34 EDTGILDGilead MAA for HIV regimen has been fully validated by EMA
Gilead Sciences announced that the company's Marketing Authorization Application, MAA, for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg has been fully validated and is now under evaluation by the European Medicines Agency, EMA. Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older. "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV."
06:01 EDTBMYBristol-Myers announces Canadian approval of Daklinza
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August 19, 2015
05:46 EDTBMYStocks with implied volatility movement; ESRX BMY
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August 18, 2015
07:22 EDTBMYBristol-Myers combo data could push shares above $70, says JPMorgan
JPMorgan analyst Chris Schott says the risk/reward for shares of Bristol-Myers Squibb looks "very attractive" ahead of the World Conference on Lung Cancer, which begins September 6. Data at the conference supportive of an Opdivo/Yervoy combo would represent a clear catalyst for the shares, Schott tells investors in a research note. Bristol is "already extremely well-positioned" in the advanced non-small cell lung cancer market, and data suggesting that the company has addressed toxicity concerns with the combo could push the stock above $70, Schott argues. Bristol closed yesterday up 39c to $63.47. The analyst sees limited downside to stock even with disappointing results at the World Conference on Lung Cancer. He reiterates an Overweight rating on Bristol with a $75 price target.

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