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Stock Market & Financial Investment News

News Breaks
March 27, 2014
07:14 EDTGILD, ABBV, BMY, MRKGilead can defend Sovaldi pricing, says RW Baird
After a letter from Democratic congressmen questioned the pricing of Gilead's (GILD) HCV treatment, Sovaldi, RW Baird believes that the company can answer the questions regarding the drug's value. The firm thinks that drugs expected to be offered by Gilead in the future will be even more defensible. Meanwhile, after reviewing abstracts recently, RW Baird believes that the most important players in the HCV space remain Gilead and AbbVie (ABBV), followed by Bristol-Myers Squibb (BMY) and Merck (MRK). RW Baird keeps an Outperform rating on Gilead.
News For GILD;ABBV;BMY;MRK From The Last 14 Days
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October 10, 2014
10:03 EDTBMYBristol-Myers receives orphan status for melanoma treatment
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08:19 EDTGILD, BMYMedivir announces Janssen initiates enrolment in phase II IMPACT study
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07:21 EDTGILDFDA PDUFA Date for Gilead Sciences Sofosbuvir is October 10, 2014
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October 9, 2014
11:43 EDTGILDStocks with call strike movement; GILD EWZ
Gilead (GILD) February 120 call option implied volatility increased 3% to 38, MSCI Brazil Index (EWZ) February 58 call option implied volatility increased 3% to 38 according to IVolatility.
08:32 EDTMRKMerck HCV solutions becoming more credible, says Bernstein
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08:28 EDTABBV, GILDGilead to be challenged by AbbVie in HCV near-term, says Bernstein
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October 8, 2014
16:26 EDTGILDOn The Fly: Closing Wrap
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16:01 EDTGILDOptions Update; October 8, 2014
iPath S&P 500 VIX Short-Term Futures down 2.73 to 29.51. Option volume leaders: AAPL TSLA TWTR AMZN FB NFLX PBR AA CLF GILD according to Track Data.
15:49 EDTGILDAchillion, Gilead rise after late breaking abstract for AASLD posted
Shares of Achillion (ACHN) are higher after the company announced this morning that four abstracts have been accepted for presentation at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases. Among those four is a late breaker poster presentation providing updated results, including SVR12, from an ongoing Phase 2 proxy study evaluating Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus infection. Sofosbuvir is sold under the brand name Sovaldi by Gilead Sciences (GILD). In a note to investors, FBR Capital noted that the "surprise" late-breaking poster for the meeting showed a 100% cure rate for the combination therapy. In late afternoon trading, Achillion shares are up 10% to $10.74 while Gilead is up 4.3% to $108.78.
11:14 EDTMRKMerck presents new MK-5172/MK-8742 clinical study data
Merck announced that new data from clinical studies of the company’s investigational, oral, once-daily, fixed-dose combination chronic hepatitis C treatment grazoprevir/elbasvir, or MK-5172/MK-8742, are scheduled to be presented at the 65th American Association for the Study of Liver Diseases Annual Meeting, also known as The Liver Meeting. The meeting is scheduled to take place from November 7-11. New data will also be presented for MK-3682, formerly IDX21437, as part of its purchase of Idenix Pharmaceuticals.
11:08 EDTMRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analyst discusses IMPROVE-IT's regulatory and commercial implications for novel LDL-lowering therapies on an Analyst/Industry conference call to be held on October 9 at 2 pm.
10:55 EDTMRKLeerink pharmaceuticals analyst holds an analyst/industry conference call
Analysts discuss prospects for drugs that raise HDL cholesterol, effects of CETP mechanism, expectations for REVEAL data and the potential place for CETP inhibitors in a crowded hypersholesterolemia landscape on an Analyst/Industry conference call to be held on October 9 at 11 am.
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 EDTMRK, GILD, BMY, ABBVInfectious Diseases Society of America to hold a conference
ID Week 2014 is being held in Philadelphia on October 8-12.
October 7, 2014
08:34 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor, which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need. Bristol-Myers says "The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world. We plan to submit additional data for daclatasvir to the FDA from our ongoing clinical trial program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV. Next month at the annual meeting of The American Association for the Study of Liver Diseases, we will present new data from several daclatasvir-based regimens. We look forward to bringing daclatasvir to patients in the U.S. and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible."
08:33 EDTBMYBristol-Myers withdrawing NDA for asunaprevir
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October 6, 2014
08:10 EDTABBVAbbVie's Humira receives FDA approval for extension of JIA
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08:04 EDTBMYBristol-Myers announces Opdivo clinical trial with Novartis therapies
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08:02 EDTBMYBristol-Myers announces research collaboration to evaluate Opdivo
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05:14 EDTBMYNovartis announce clinical collaboration with Bristol-Myers
Novartis (NVS) announced that it has entered into a clinical collaboration with Bristol-Myers Squibb (BMY) to evaluate the safety, tolerability and preliminary efficacy of three molecularly targeted compounds in combination with Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor, Opdivo, in Phase I/II trials of patients with non-small cell lung cancer, or NSCLC. Both studies will be conducted by Novartis. One trial will evaluate the combination of Opdivo with Zykadia, an FDA-approved treatment for patients with anaplastic lymphoma kinase-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. A second study will investigate Opdivo with INC280, a potent and highly selective inhibitor of c-MET receptor tyrosine kinase, and separately with EGF816, a potent, third-generation EGFR tyrosine kinase inhibitor that is active against T790 mutations. INC280 and EGF816 are currently being investigated in various Phase I/II NSCLC trials. Additional details of the collaboration were not disclosed.
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