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News Breaks
January 9, 2014
08:38 EDTVRTX, BMYVertex announces first data from initial cohorts of VX-135 Phase 2a study
Vertex Pharmaceuticals (VRTX) announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135 in combination with daclatasvir, Bristol-Myers Squibb's (BMY) NS5A replication complex inhibitor. In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment was 83% in treatment-naïve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. In this arm, one patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. In the study, the majority of adverse events were mild. Vertex expects to submit data to present at a medical meeting in 2014.
News For VRTX;BMY From The Last 14 Days
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October 17, 2014
10:27 EDTVRTXVertex FDA panel expected to be positive at Piper Jaffray
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10:26 EDTVRTXFDA panel asked to consider benefit of Vertex drug in younger CF patients
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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
13:59 EDTVRTXVertex mentioned cautiously at BofA/Merrill
11:23 EDTBMYBIND Therapeutics and The Conference Forum hold a conference
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October 13, 2014
10:08 EDTVRTXOn The Fly: Analyst Upgrade Summary
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09:23 EDTVRTXVertex price target raised to $131 from $119 at RW Baird
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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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05:35 EDTVRTXVertex upgraded to Overweight from Neutral at Piper Jaffray
Piper Jaffray upgraded Vertex Pharmaceuticals to Overweight citing likely approval of the company's Kalydeco plus lumacaftor combination next year. Piper expects Vertex's Cystic Fibrosis sales to grow to $3.1B in 2016 and raised its price target for shares to $125 from $87.50.
October 10, 2014
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:24 EDTVRTXVertex price target raised to $117 from $109 at Maxim
Maxim raised its price target for Vertex shares to $117 after the company gave an update at the Cystic Fibrosis Conference. The form keeps a Buy rating on the stock.
08:19 EDTBMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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October 9, 2014
09:33 EDTVRTXVertex says VX-661 Phase 2 study fully enrolled
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07:22 EDTVRTXCystic Fibrosis Foundation to hold a conference
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October 8, 2014
08:03 EDTBMYBristol-Myers resolves outstanding U.S. litigation on efavirenz
Bristol-Myers Squibb Company says it has "successfully resolved all outstanding U.S. patent litigation relating to efavirenz, an active ingredient contained in our Sustiva -- efavirenz -- and Atripla products. Accordingly, we believe that loss of exclusivity in the U.S. for efavirenz should not occur until December 2017. Bristol-Myers Squibb remains committed to delivering our medicines and to developing new and innovative treatments to help patients prevail over serious disease. Atripla is currently the #1 prescribed U.S. regimen in its category, with over 8 million prescriptions written since its launch in 2006. Earlier this year the company submitted a new drug application to the U.S. Food and Drug Administration for a fixed-dose combination of atazanavir sulfate and cobicistat, an investigational pharmacokinetic enhancer. In addition, studies are ongoing for new treatments including an HIV-1 attachment inhibitor, an HIV-1 maturation inhibitor and an anti-PD-L1. The establishment of intellectual property rights allows Bristol-Myers Squibb to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We will continue to defend our intellectual property rights against infringement as we remain focused on providing a deep and broad portfolio of innovative medicines to patients around the world."
07:18 EDTBMYInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
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