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Stock Market & Financial Investment News

News Breaks
May 20, 2014
08:15 EDTSGEN, MNK, CGIX, AHS, GILD, ARRY, QSII, EXELUBS 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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August 27, 2015
09:26 EDTEXELOn The Fly: Pre-market Movers
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06:07 EDTEXELExelixis' cobimetinib granted first regulatory approval in Switzerland
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August 26, 2015
17:06 EDTGILDGilead AMBITION study results published in New England Journal of Medicine
Gilead Sciences (GILD) announced detailed results from the AMBITION study. In AMBITION, conducted in collaboration with GlaxoSmithKline (GSK), combination therapy with Letairis and tadalafil reduced the risk of clinical failure by 50% compared to the pooled Letairis and tadalafil monotherapy arm. These data were published in The New England Journal of Medicine. Letairis, a selective endothelin type-A receptor antagonist, and tadalafil, a PDE5 inhibitor, are each approved in the United States, the European Union and other countries as once-daily treatments for patients with pulmonary arterial hypertension with WHO/NYHA functional class II and III symptoms. Letairis is indicated in the U.S. to improve exercise ability and delay clinical worsening and in the EU under the tradename Volibris to improve exercise capacity. Tadalafil 40 mg is indicated in the U.S. and the EU to improve exercise ability and capacity, respectively. Preclinical data have suggested these therapies may have synergistic effects. However, combination use with Letairis and tadalafil is currently not approved.
August 25, 2015
19:34 EDTGILDExperts tell White House to expand use of Hepatitis C drugs, NYT says
Health care experts from the Public Health Service and the Advisory Council on H.I.V./AIDS have recommended that Medicaid officials expand the use of costly Hepatitis C drugs including AbbVie's (ABBV) Viekira Pak and Gilead's (GILD) Sovaldi and Harvoni, reports the New York Times, citing correspondence sent to the White House. The advisory council said current usage limitations on the drugs are "unreasonable," but it also suggested that manufacturers disclose drug development costs in the face of the significant price tags on modern Hepatitis C treatments. Reference Link
August 24, 2015
13:36 EDTGILDBiotech correction presents some opportunities, says RBC Capital
RBC Capital analyst Michael Yee said he won't try to pick the short-term bottom in biotech, but contends that any macro weakness in China shouldn't have any major impact to financials or fundamentals for the sector given their minimal exposure there. If the market continues to be volatile, Yee recommends a focus on names with defensive characteristics, such as higher margins and free cash flow yield, naming Amgen (AMGN), Celgene (CELG) and Gilead (GILD) as some examples. The analyst adds that he likes Vertex (VRTX) on the pullback for "more aggressive" growth investors. Yee has Outperform ratings on all of the stocks mentioned above.
08:32 EDTEXELExelixis granted FDA Breakthrough Therapy Designation for cabozantinib
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August 21, 2015
17:29 EDTARRYArray BioPharma files automatic mixed securities shelf
August 20, 2015
16:34 EDTGILDGilead MAA for HIV regimen has been fully validated by EMA
Gilead Sciences announced that the company's Marketing Authorization Application, MAA, for an investigational, once-daily single tablet regimen that combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and rilpivirine 25 mg has been fully validated and is now under evaluation by the European Medicines Agency, EMA. Emtricitabine and tenofovir alafenamide are marketed by Gilead Sciences and rilpivirine is marketed by Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The data included in the application support the use of R/F/TAF for the treatment of HIV-1 infection in adults and pediatric patients 12 years and older. "With this validation, R/F/TAF is now the third TAF-based filing under review by the EMA as we advance a portfolio of new treatment options that may offer high efficacy and favorable safety profiles," said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. "The R/F/TAF filing also represents the next step in our collaboration with Janssen to develop HIV treatments that potentially meet the diverse needs of people living with HIV."
August 18, 2015
06:23 EDTSGENSeattle Genetics approvals already factored into forecast, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff believes the FDA approval for Adcetris in post-transplant consolidation Hodgkin's Lymphoma as well as the "positive surprise" of the FDA converting the accelerated approval in relapsed HL to standard approval is already factored into in his sales forecast of $220M this year for the drug. He keeps an Underweight rating on Seattle Genetics with a $30 price target.
August 17, 2015
19:00 EDTSGENOn The Fly: After Hours Movers
UP AFTER EARNINGS: Fabrinet (FN), up 5.1%. ALSO HIGHER: Esperion Therapeutics (ESPR), up 10.6% after announcing that it is on track to initiate ETC-1002 Phase 3 program by the end of 2015... Seattle Genetics (SGEN), up 3.3% after announcing FDA approval of Adcetris for HL treatment. DOWN AFTER EARNINGS: MasTec (MTZ), down 7.4%... Urban Outfitters (URBN), down 2.3%. ALSO LOWER: Sunedison (SUNE), down 1% after announcing a $500M perpetual convertible preferred stock offering.
16:14 EDTSGENSeattle Genetics announces FDA approval of Adcetris for HL treatment
Seattle Genetics announced that the U.S. Food and Drug Administration has approved ADCETRIS, brentuximab vedotin, for the treatment of patients with classical Hodgkin lymphoma, HL, at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation consolidation. The approval is based on a phase 3 clinical trial called AETHERA that was designed to compare up to 16 cycles of ADCETRIS therapy administered every three weeks following auto-HSCT to placebo. The primary endpoint was met with a significant improvement in median progression-free survival of 42.9 months for patients who received ADCETRIS versus 24.1 months for patients who received placebo, an improvement of 18.8 months. In addition, data from the AETHERA trial converted the U.S. accelerated approval of the relapsed classical HL indication to regular approval. ADCETRIS is an antibody-drug conjugate directed to CD30, which is expressed in classical HL and systemic anaplastic large cell lymphoma, as well as other lymphoma subtypes. This is the third indication for ADCETRIS, which was granted accelerated FDA approval in August 2011 for two other indications: (1) treatment of Hodgkin lymphoma patients who fail autologous transplant or who fail at least two prior multi-agent chemotherapy regimens and are not autologous transplant candidates, and (2) treatment of systemic ALCL patients who fail at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
06:22 EDTEXEL, SGEN, ARRYPiper's Tenthoff sees select biotech names outperforming in second half
Piper Jaffray analyst Edward Tenthoff expects drug launches, clinical data read-outs and potential partnerships to drive outperformance for select biotech names in the second half of 2015. Despite some recent profit-taking, 2015 has been another strong year for biotech stocks, Tenthoff tells investors in a research note. Names with important second half of the year catalysts include Vertex (VRTX), Regeneron (REGN), Seattle Genetics (SGEN), Exelixis (EXEL), Sarepta (SRPT), Novavax (NVAX), Arrowhead (ARWR), Array BioPharma (ARRY), Alnylam (ALNY), Genocea (GNCA), CymaBay (CBAY), Idera Pharmaceuticals (IDRA), Vitae Pharmaceuticals (VTAE).
05:34 EDTQSIIQuality Systems Chief Technology Officer Steve Puckett resigns
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