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December 26, 2012
07:34 EDTPFE, BMYPfizer, 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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July 25, 2014
06:00 EDTBMYBristol-Myers implied volatility of 17 at lower end of index mean range
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July 24, 2014
11:22 EDTBMYBristol-Myers says considering different sizes of deal opportunities
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10:57 EDTBMYBristol-Myers says M&A would have to be good strategic fit
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10:48 EDTBMYBristol-Myers says guidance assumes R&D credit will be extended
Says Reyataz seeing increased competitive pressure. Says business development a top priority for capital allocation. Comments made on the Q2 earnings conference call.
08:28 EDTBMYBristol-Myers management to meet with JPMorgan
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07:32 EDTBMYBristol-Myers reaffirms 2014 EPS outlook $1.70-$1.80, consensus $1.77
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07:31 EDTBMYBristol-Myers reports Q2 EPS 48c, consensus 44c
Reports Q2 revenue $ $3.89B, consensus $3.85B.
05:26 EDTBMYBristol-Myers, Ono Pharmaceutical announces strategic collaboration in Japan
Bristol-Myers Squibb and Ono Pharmaceutical have signed a strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens to help address the unmet medical needs of patients with cancer in Japan, South Korea and Taiwan. As part of the agreement, Bristol-Myers Squibb and Ono will jointly develop and commercialize Opdivo and Yervoy across a broad range of tumor types. Bristol-Myers Squibb and Ono will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries.
July 23, 2014
15:30 EDTBMYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Ford (F), consensus 36c; General Motors (GM), consensus 58c; Potash (POT), consensus 46c; Caterpillar (CAT), consensus $1.52; 3M (MMM), consensus $1.91; Union Pacific (UNP), consensus $1.43; Bristol-Myers Squibb (BMY), consensus 44c; Eli Lilly (LLY), consensus 65c; Celgene (CELG), consensus 89c; Precision Castparts (PCP), consensus $3.35; Raytheon (RTN), consensus $1.59; Noble Energy (NBL), consensus 79c; Hershey (HSY), consensus 76c; Southwest Airlines (LUV), consensus 61c; Boston Scientific (BSX), consensus 19c; JetBlue (JBLU), consensus 19c.
15:10 EDTBMYBristol-Myers technical comments before earnings
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July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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July 21, 2014
06:43 EDTBMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 17, 2014
08:08 EDTBMY, PFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
06:26 EDTBMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTBMYPerrigo retreats after analyst sees limited potential buyers
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07:35 EDTBMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
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