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News Breaks
December 26, 2012
07:34 EDTBMY, PFEPfizer, Bristol-Myers announce Japanese approval of Eliquis
Bristol-Myers Squibb (BMY) and Pfizer (PFE) announced that the Japanese Ministry of Health, Labor and Welfare has approved ELIQUIS for the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). ELIQUIS is a novel anticoagulant that has demonstrated risk reductions versus warfarin in three important outcomes of stroke, major bleeding and all-cause death. ELIQUIS is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. This is the third approval for ELIQUIS for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, following approvals in the European Union and Canada. The companies continue to progress the ELIQUIS application for stroke prevention in atrial fibrillation in other markets. On September 26, The U.S. Food and Drug Administration acknowledged receipt of the ELIQUIS New Drug Application resubmission to reduce the risk of stroke and systemic embolism in adult patients with NVAF. The FDA has deemed the resubmission a complete response to its June 22, 2012 Complete Response Letter that requested additional information on data management and verification from the ARISTOTLE trial. The FDA Prescription Drug User Fee Act date is March 17, 2013.
News For PFE;BMY From The Last 14 Days
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January 29, 2016
07:49 EDTBMYBristol-Myers, AbbVie receive 'positive' CHMP opinion for Empliciti
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05:39 EDTPFEPfizer: LIS awards infliximab biosimilar tender to Inflectra, Reuters reports
Pfizer says that the Norwegian Drug Procurement Cooperation has awarded its product Inflectra an infliximab biosimilar tender, Reuters reports. Reference Link
January 28, 2016
12:42 EDTBMYBristol-Myers says EU approves Daklinza for treatment of chronic hepatitis C
Bristol-Myers Squibb announced that the European Commission has approved Daklinza for the treatment of chronic hepatitis C in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. Daklinza is already approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza + sofosbuvir regimen is the only approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis. The new indications are based on data from the ALLY-1 clinical trial and ALLY-2 clinical trial. The recommended treatment regimens and durations are as follows:
09:27 EDTBMYBristol-Myers reports Q4 US revenue $2.3B
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09:27 EDTBMYBristol-Myers sees FY16 non-GAAP EPS $2.30-$2.40, consensus $2.29
Sees FY16 revenue up in mid-single digit range, consensus $17.4B. Sees FY16 gross margin as percentage of revenue ot be approximately 75%-76%. Sees FY16 marketing, sales and administrative expenses decreasing in mid-single digit range. Sees FY16 R&D expenses increasing in high-single digit range. Sees FY16 effective tax rate between 21%-22%.
09:25 EDTBMYBristol-Myers reports Q4 non-GAAP EPS 38c, consensus 28c
Reports Q4 revenue $4.29B, consensus $4.15B.
07:11 EDTBMYBristol-Myers: DMC concluded that CheckMate Phase 3 study met primary endpoint
07:00 EDTBMYBristol-Myers says CheckMate-141 Opdivo Phase 3 trial stopped early
Bristol-Myers Squibb announced that a randomized Phase 3 study evaluating Opdivo versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon. "With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer." CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -141 data, and work with investigators on the future presentation and publication of the results.
January 27, 2016
14:34 EDTBMYNotable companies reporting before tomorrow's open
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14:17 EDTBMYBristol-Myers technical comments before earnings news
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13:55 EDTBMYBristol-Myers volatility elevated into Q4 and outlook
Bristol-Myers Black & Decker January weekly call option implied volatility is at 49, February is at 30; compared to its 52-week range of 18 to 43, suggesting large near term price movement into the expected release of Q4 results on January 28.
January 25, 2016
10:00 EDTBMYOn The Fly: Analyst Downgrade Summary
Today's noteworthy downgrades include: American Eagle (AEO) downgraded to Hold from Buy at BB&T... American Express (AXP) downgraded on weak revenue outlook at Argus... Bristol-Myers (BMY) downgraded to Market Perform from Outperform at BMO Capital... Caterpillar (CAT) downgraded to Sell from Neutral at Goldman... Crestwood Equity (CEQP) downgraded to Neutral on potential distribution cut at Baird... Cummins (CMI) downgraded to Neutral from Buy at Citi... Federal Realty (FRT) downgraded to Hold from Buy at Evercore ISI... GKN PLC (GKNLY) downgraded to Neutral from Outperform at Credit Suisse... Galapagos NV (GLPG) downgraded to Neutral from Buy at GoldmanvHortonworks (HDP) downgraded to Perform from Outperform at Oppenheimer... International Flavors (IFF) downgraded on headwinds at Stifel... International Paper (IP) downgraded to Neutral from Buy at Citi... JPMorgan (JPM) downgraded to Neutral from Buy at Nomura... KapStone (KS) downgraded to Underperform from Neutral at Macquarie... Mosaic (MOS) downgraded to Neutral from Overweight at JPMorgan... NetSuite (N) downgraded to Equal Weight from Overweight at Stephens... ONEOK Partners (OKS) downgraded to Neutral at Baird... OvaScience (OVAS) downgraded to Perform from Outperform at Oppenheimer... Packaging Corp. (PKG) downgraded to Neutral from Buy at Citi... Potash (POT) downgraded to Neutral from Overweight at JPMorgan... Power Solutions (PSIX) downgraded to Neutral from Overweight at Piper Jaffray... Raymond James (RJF) downgraded to Neutral from Buy at Nomura... Regeneron (REGN) downgraded to Sell from Neutral at Chardan... SanDisk (SNDK) downgraded to Underperform from Outperform at CLSA... Toll Brothers (TOL) downgraded to Market Perform from Outperform at JMP Securities... Twitter (TWTR) downgraded to Hold from Buy at Stifel... WPX Energy (WPX) downgraded to Sector Perform from Outperform at Iberia... WestRock (WRK) downgraded to Neutral from Buy at BofA/Merrill... Whole Foods (WFM) downgraded to Underperform from Market Perform at BMO Capital... Zurich Insurance (ZURVY) downgraded to Neutral from Outperform at Exane BNP Paribas.
08:27 EDTBMYBristol-Myers downgraded at BMO Capital
As noted earlier, BMO Capital downgraded Bristol-Myers to Market Perform from Outperform. The firm says that its positive thesis on clinical catalysts for the company's Opdivo drug has "mostly materialized." Target to $70 from $74.
08:04 EDTBMYAgilent's Dako announces FDA expanded approval of Dako PD-L1 IHC 28-8 pharmDx
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06:05 EDTBMYBristol-Myers downgraded to Market Perform from Outperform at BMO Capital
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January 24, 2016
13:50 EDTBMYBristol-Myers says FDA expands indication for Opdivo-Yervoy
Bristol-Myers Squibb announced that the FDA has approved Opdivo, or nivolumab, in combination with Yervoy, or ipilimumab, for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. "This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials," the company noted. The approval expands the original indication for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial. The FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients.
January 22, 2016
09:29 EDTBMYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: ABB (ABB) upgraded to Neutral from Sell at UBS... ACADIA (ACAD) upgraded to Overweight from Neutral at Piper Jaffray... ASML (ASML) upgraded to Hold from Sell at Deutsche Bank... Alaska Air (ALK) upgraded to Buy from Hold at Deutsche Bank... Arrow Electronics (ARW) upgraded to Buy from Neutral at Longbow... Avnet (AVT) upgraded to Buy from Neutral at Longbow... Avon Products (AVP) upgraded to Overweight from Neutral at Piper Jaffray... BankUnited (BKU) upgraded to Buy from Hold at Sandler O'Neill... Barclays (BCS) upgraded to Hold from Sell at Berenberg... Bristol-Myers (BMY) upgraded to Buy from Hold at Berenberg... CA Technologies (CA) upgraded to Buy from Neutral at Mizuho... CaixaBank (CAIXY) upgraded to Buy from Neutral at Nomura... Canadian Pacific (CP) upgraded to Outperform from Sector Perform at RBC Capital... Cardinal Financial (CFNL) upgraded to Outperform from Market Perform at Keefe Bruyette... Columbia Sportswear (COLM) upgraded to Outperform at Baird... Dr Pepper Snapple (DPS) upgraded to Outperform from Underperform at CLSA... Gorman-Rupp (GRC) upgraded to Outperform from Neutral at Boenning & Scattergood... Independent Bank (INDB) upgraded to Buy from Neutral at Compass Point... JD.com (JD) upgraded to Buy from Neutral at Nomura... KeyCorp (KEY) upgraded to Overweight from Equal Weight at Stephens... Lincoln National (LNC) upgraded to Strong Buy from Outperform at Raymond James... Masco (MAS) upgraded to Outperform at Baird... MetLife (MET) upgraded to Strong Buy from Market Perform at Raymond James... Northern Trust (NTRS) upgraded to Buy from Hold at Sandler O'Neill... Pacific Continental (PCBK) upgraded to Outperform at Keefe Bruyette... Qualcomm (QCOM) upgraded to Outperform from Market Perform at Northland... SL Green Realty (SLG) upgraded to Buy from Neutral at SunTrust... SVB Financial (SIVB) upgraded to Overweight from Neutral at Piper Jaffray... SunPower (SPWR) upgraded to Overweight from Equal Weight at Barclays... WEX Inc. (WEX) upgraded to Outperform from Market Perform at Wells Fargo.
08:11 EDTBMYMerck price target lowered to $58 from $67 at Leerink
Leerink analyst Seamus Fernandez lowered his price target for Merck (MRK) to $58 citing his expectation for Bristol-Myers (BMY) to remain the leader in the immuno-oncology market as well as a "harder to penetrate" hepatitis C virus market. Nonetheless, the analyst believes headwinds facing Januvia, Keytruda and the HCV franchise are reflected in Merck shares at current levels. Fernandez keeps a Market Perform rating on the name.
06:31 EDTBMYLeerink recommends buying Bristol-Myers shares now
Leerink analyst Seamus Fernandez recommends buying shares of Bristol-Myers now saying the company's dominance of the immuno-oncology market "is likely to continue for at least the next several years." The analyst expects Bristol to see "substantial operating leverage" in the second half of 2016 as the company annualizes the loss of Abilify profits. He raised his price target for the shares to $78 from $77 and keeps an Outperform rating on the name.
06:07 EDTBMYBristol-Myers upgraded to Buy from Hold at Berenberg
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