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News Breaks
May 20, 2014
08:15 EDTQSII, EXEL, SGEN, MNK, CGIX, AHS, GILD, ARRYUBS to hold a conference
2014 Global Healthcare Conference to be held in New York on May 19-21 with webcasted company presentations to begin on May 20 at 8 am; not all company presentations may be webcasted. Webcast Link
News For ARRY;CGIX;EXEL;GILD;MNK;QSII;AHS;SGEN From The Last 14 Days
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February 27, 2015
07:37 EDTGILDGilead removed from the short-term buy list at Deutsche Bank
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February 26, 2015
19:09 EDTGILDGilead announces Phase 3 results for once-daily single tablet HIV regimen
Gilead Sciences announced detailed 48-week results from two Phase 3 studies, Studies 104 and 111, evaluating its investigational once-daily single tablet regimen containing tenofovir alafenamide, or TAF, for the treatment of HIV-1 infection in treatment-naďve adults. A regimen of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and TAF 10 mg was found to be statistically non-inferior to Gilead’s Stribild, containing elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, based on percentages of patients with HIV-1 RNA levels less than 50 copies/mL. A second analysis found that patients receiving the TAF regimen also had significantly better renal and bone laboratory parameters than those treated with Stribild. The data were presented in two late-breaker presentations at the 22nd Conference on Retroviruses and Opportunistic Infections in Seattle.
15:25 EDTGILDGilead announces 96% SVR12 rate in Phase 3 study of Harvoni
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February 25, 2015
15:30 EDTGILDGilead announces preclincal data on investigational TLR7 agonist
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February 24, 2015
16:55 EDTEXELExelixis provides 2015 outlook
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16:54 EDTEXELExelixis reports Q4 EPS (30c), consensus (30c)
Reports Q4 revenue $7.4M, consensus $7.8M.
09:35 EDTGILDActive equity options trading on open
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07:47 EDTCGIXCancer Genetics to present new data at 2015 ASCO genitourinary cancers symposium
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February 23, 2015
16:00 EDTGILDOptions Update; February 23, 2015
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11:17 EDTARRYFTC puts conditions on Novartis's proposed acquisition of GSK oncology drugs
According to the FTC, Global pharmaceutical company Novartis (NVS) has agreed to divest all assets related to its BRAF and MEK inhibitor drugs, currently in development, to Boulder, Colorado-based Array BioPharma (ARRY) to settle charges that Novartis’s $16B acquisition of GlaxoSmithKline’s (GSK) portfolio of cancer-treatment drugs would likely be anticompetitive...If the acquisition goes forward as proposed, Novartis would likely delay or terminate development of both its BRAF and MEK inhibitors, as well as the combination product. For that reason, Novartis’s acquisition of GSK’s portfolio of cancer-treatment drugs would likely cause significant competitive harm in the U.S. markets for both the BRAF and MEK inhibitors, ultimately raising prices for consumers and depriving them of potentially superior products. Under the terms of the proposed consent agreement, Novartis is required to provide transitional services to Array BioPharma to ensure that development of the BRAF and MEK inhibitors continues uninterrupted and that competition in BRAF and MEK inhibitor markets is not reduced. Reference Link
09:39 EDTGILDActive equity options trading on open
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07:16 EDTGILDMylan signs exclusive agreement with Gilead to distribute Solvaldi, Harvoni
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February 19, 2015
16:24 EDTAHSAMN Healthcare sees Q1 revenue $310M-$314M, consensus $275.11M
Sees Q1 gross margin is expected to be approximately 30.5%. SG&A expenses as a percentage of revenue are expected to be approximately 22.5%. Adjusted EBITDA margin is expected to be 8.5%-9.0%.
16:23 EDTAHSAMN Healthcare reports Q4 adjusted EPS 21c, consensus 18c
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10:32 EDTEXELHigh option volume stocks:
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09:35 EDTGILDOption volume leaders
Option volume leaders: AAPL TSLA TWTR MCD WMT PBR SPWR WFM GILD FB SCTY according to Track Data.
09:12 EDTEXELOn The Fly: Pre-market Movers
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05:31 EDTEXELExelixis announces acceptance of NDA for Genentech cobimetinib
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February 18, 2015
09:37 EDTGILDOption volume leaders on open
Option volume leaders: AAPL TSLA TWTR CELG APO NFLX AXP APA LNKD C GILD according to Track Data.
09:05 EDTSGENSeattle Genetics submits supplemental BLA to FDA for Phase 3 Aethera trial
Seattle Genetics announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration based on data from the phase 3 AETHERA trial of ADCETRIS as consolidation therapy immediately following an autologous stem cell transplant in Hodgkin lymphoma patients at high risk of relapse. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma. ADCETRIS is approved in relapsed HL and sALCL but is currently not approved for consolidation therapy in HL patients immediately after ASCT. The supplemental BLA is based on positive results from a phase 3 clinical trial called AETHERA that were presented at the 56th American Society of Hematology Annual Meeting in December 2014. Results from the AETHERA trial in 329 HL patients at high risk of relapse included: The trial achieved its primary endpoint and demonstrated a significant increase in progression-free survival per independent review facility, with a hazard ratio of 0.57 and a p-value of 0.001. Median PFS was 43 months for patients who received ADCETRIS versus 24 months for patients who received placebo. The two-year PFS rate was 63 percent in the ADCETRIS arm compared to 51 percent in the placebo arm. The PFS benefit was consistent across all pre-specified subgroups, including primary refractory patients, patients who relapsed within twelve months of frontline therapy and patients who relapsed after twelve months with extranodal disease.
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