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June 9, 2014
07:34 EDTMYL, BMYMylan launches generic version of Bristol-Myers' Paraplatin
Mylan (MYL) announced the launch of carboplatin injection 50mg / 5 ml, in multi-dose vials, which is the generic version of Bristol-Myers' (BMY) Paraplatin injection. Mylan received final FDA approval for its ANDA for this product and also received final approval from the FDA for 150 mg/ 15 ml, 450 mg / 45 ml, and 600 mg / 60 ml versions, which it intends to launch subsequently.
News For MYL;BMY From The Last 14 Days
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July 23, 2015
09:04 EDTMYLTeva says 'strongly disagrees' with Stichting stated analysis
Teva Pharmaceutical Industries (TEVA) issued the following statement regarding Stichting Preferred Shares Mylan’s (MYL) decision to exercise its call option: "We strongly disagree with the stated analysis of Stichting Preferred Shares Mylan and its decision to exercise its call option, which is unwarranted, relies on false assumptions, and risks depriving Mylan stockholders and other stakeholders of the value inherent in a combination of Teva and Mylan. We continue to believe that our proposed transaction offers a compelling opportunity for value-creation and many other benefits for the stockholders, customers, patients, and employees of both companies. We are well advised on Dutch law, including the ability of Mylan stockholders to challenge this action in court, and are prepared to take the necessary actions at the appropriate time."
08:48 EDTMYLMylan, Teva lower after Stitching looks to thwart hostile deal
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08:48 EDTMYLMylan confirms exercise of full call option by independent foundation
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08:34 EDTMYLMylan foundation exercises call option to 'level playing field'
08:33 EDTMYLMylan foundation says shareholders at risk of Teva takeover
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07:34 EDTBMYBristol-Myers raises FY15 adjusted EPS view to $1.70-$1.80 from $1.60-$1.70
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07:31 EDTBMYBristol-Myers reports Q2 EPS 53c, consensus 36c
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06:38 EDTBMYBristol-Myers' two Opdivo applications validated by European Medicines Agency
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July 22, 2015
15:26 EDTBMYNotable companies reporting before tomorrow's open
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10:06 EDTMYLAbbott CEO says supportive of Mylan pursuit of Perrigo
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09:30 EDTMYLAbbott CEO says 'pretty alligned' with Mylan so far
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.
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.
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.
08:38 EDTMYLAnalyst predicts Zoetis merges with Bayer unit, not Valeant
Zoetis (ZTS) in recent months has been the subject of takeover speculation, possibly for Valeant (VRX), but a Jefferies analyst told investors today in a research note that he views a deal with a unit of healthcare giant Bayer (BAYRY) as "highly likely" for the animal medicine company. BACKGROUND: Bill Ackman of Pershing Square, who owns stakes in both Zoetis and Valeant, said in early May while speaking on CNBC that Zoetis is a "great” business on a standalone basis, but he also spoke of the company's strategic value. Ackman added, however, that he was "not sure" that Valeant was the best acquirer of Zoetis. Subsequently, in late June, The Wall Street Journal reported that Valeant made a preliminary approach regarding a potential deal to buy Zoetis. CNBC's David Faber said the next day, citing his own sources, that Valeant reached out to Zoetis as a courtesy to common shareholder Ackman and was unlikely to pursue an acquisition of the company, though he cautioned then Valeant could change its approach and pursue a deal. BAYER: Jefferies analyst Jeffrey Holford said in a note today that he views a tie-up between Zoetis and Bayer's Animal Health business in 2016 as "highly likely." He sees Mylan's (MYL) acquisition of Abbott's (ABT) non‑U.S. developed markets specialty and branded generics business as a potential proxy for how a transaction could be structured, adding that such a "spinversion" could achieve up to 36% long-term earnings accretion for Zoetis. Holford reiterated a Buy rating on Zoetis with a $60 price target, while downgrading Bayer to Hold, citing valuation following the recent outperformance of its shares. IDEXX: While being discussed as a target, some analysts have also opined on companies that Zoetis could pursue as a buyer. On June 29, Canaccord said that in investor meetings with IDEXX (IDXX) executives declined to comment on Zoetis' potential interest in scaling up its animal health diagnostics business. Canaccord added that it thought Zoetis could make a bid for IDEXX. The firm reiterated its Buy rating and $80 price target on IDEXX shares at that time. PRICE ACTION: Since June 25, the day the Journal first reported on Valeant's preliminary takeover approach to Zoetis, the animal health company's shares have dropped nearly 4%. Zoetis closed down 20c to $47.80 on Friday.
08:28 EDTBMYExelixis off highs, but still up 34% after Bristol-Myers data
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08:05 EDTBMYBristol-Myers says Phase III study evaluating Opdivo stopped early
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07:33 EDTMYL, BMYInternational AIDS Society to hold a conference
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07:30 EDTMYLZoetis 'highly likely' to merge with Bayer unit in 2016, says Jefferies
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