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News Breaks
July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.
News For BMY From The Last 14 Days
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October 24, 2014
16:02 EDTBMYOptions Update; October 24, 2014
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11:15 EDTBMYBristol-Myers says has capacity for large deal
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10:42 EDTBMYBristol-Myers sees coming in closer to high end of FY14 EPS guidance
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10:10 EDTBMYBristol-Myers to host conference call
Conference call to review data presented at the Chicago Multidisciplinary Symposium on Thoracic Oncology (CMSTO) will be held on October 31 at 2:30 pm. Webcast Link
07:35 EDTBMYBristol-Myers reports Q3 Eliquis revenue $216M
Reports Q3 Baraclude revenue $325M, Sprycel revenue $385M, Yervoy revenue $350M. Reports Q3 Abilify revenue $449M, Orencia revenue $444M.
07:33 EDTBMYBristol-Myers confirms FY14 adjusted EPS view $1.70-$1.80, consensus $1.78
Cuts FY14 GAAP EPS view to $1.15-$1.25 from $1.50-$1.60. Both GAAP and non-GAAP guidance assume current exchange rates and that the R&D tax credit will be extended by Congress in 2014. Sees FY14 worldwide revenue $15.2B-$15.8B, consensus $15.58B. Also sees: Full-year gross margin as a percentage of revenues between 75% and 76%. Advertising and promotion expense decreasing in the mid-teen-digit range. Marketing, sales and administrative expenses decreasing in the mid-single-digit range. Research and development expenses growing in the mid-single-digit range. An effective tax rate of 19% - 20%.
07:31 EDTBMYBristol-Myers reports Q3 adjusted EPS 45c, consensus 42c
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October 23, 2014
15:39 EDTBMYNotable companies reporting before tomorrow's open
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October 21, 2014
07:15 EDTBMYFDA to hold workshop on breast cancer drug development
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October 20, 2014
07:19 EDTBMYIBC Life Sciences to hold a conference
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October 16, 2014
10:01 EDTBMYOn The Fly: Analyst Upgrade Summary
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08:42 EDTBMYBristol-Myers upgraded at BMO Capital
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06:16 EDTBMYBristol-Myers upgraded to Outperform from Market Perform at BMO Capital
October 15, 2014
09:57 EDTBMYLeerink biotech analysts hold an analyst/industry conference call
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October 14, 2014
11:23 EDTBMYBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
08:05 EDTBMYBristol-Myers, Pharmacyclics, Janssen announce clinical collaboration
Bristol-Myers Squibb Company (BMY), Pharmacyclics, Inc. (PCYC), and Janssen Research & Development, LLC (JNJ) announced today they have entered into a clinical trial collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor OPDIVO in combination with IMBRUVICA, an oral Bruton's tyrosine kinase inhibitor co-developed and co-marketed by Pharmacyclics and Janssen. The Phase 1/2 study will focus on evaluating the safety and anti-tumor activity of combining OPDIVO and IMBRUVICA as a potential treatment option for patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia. Bristol-Myers Squibb has proposed the name OPDIVO, which if approved by health authorities, will serve as the trademark for the investigational drug, nivolumab. OPDIVO is part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system. Each agent has individually shown activity against hematologic malignancies in clinical trials; pre-clinical evidence suggests OPDIVO and IMBRUVICA may have the potential for additive treatment effects in patients with hematologic malignancies. The study will be conducted by Janssen. Additional details of the collaboration were not disclosed.
07:13 EDTBMYBioFlorida to hold a conference
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