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News Breaks
June 25, 2014
14:46 EDTAZN, MYGNFDA panel does not back accelerated approval of Astra cancer drug, Reuters says
An FDA advisory panel said existing data do not support accelerated approval of AstraZeneca's (AZN) ovarian cancer drug, olaparib, according to Reuters. Shares of Myriad Genetics (MYGN), which is seeking FDA approval for a companion diagnostic test for olaparib, are off their earlier highs following the headlines about the FDA panel decision. Reference Link
News For AZN;MYGN From The Last 14 Days
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August 19, 2014
07:01 EDTAZNDOJ closes investigation into PLATO Brilinta clinical trial, plans no action
AstraZeneca today announced that it has received confirmation from the United States Department of Justice that it is closing its investigation into PLATO, a clinical trial with BRILINTA tablets. The government is not planning any further action. Pascal Soriot, CEO, said: “We welcome the Department of Justice’s decision not to pursue further action. We have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit BRILINTA offers to patients around the world suffering from acute coronary syndrome. As one of AstraZeneca’s growth platforms, we remain committed to delivering the full potential of this important medicine.” As part of our continued commitment to advancing the science behind cardiovascular medicine, AstraZeneca has initiated a clinical trial program for BRILINTA, its largest program involving more than 80,000 patients worldwide.
August 18, 2014
07:57 EDTAZNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 14, 2014
12:01 EDTAZNThird Point gives quarterly update on stakes
NEW STAKES: Rackspace (RAX), Finisar (FNSR), Amgen (AMGN), Ally Financial (ALLY), and AstraZeneca (AZN). INCREASED STAKES: Dollar General (DG) and Dow Chemical (DOW). DECREASED STAKES: FedEx (FDX), Hertz (HTZ), T-Mobile (TMUS) and Intrexon (XON). LIQUIDATED STAKES: Google Class A (GOOGL), Verizon (VZ) and Mondelez (MDLZ).
August 13, 2014
09:15 EDTMYGNOn The Fly: Pre-market Movers
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08:31 EDTAZNAstraZeneca says Phase 3 trials of lesinurad for gout met primary endpoints
AstraZeneca announced top-line results from CLEAR1, CLEAR2 and CRYSTAL, the pivotal Phase III clinical trials investigating the potential of lesinurad, a selective uric acid re-absorption inhibitor, as a combination therapy for the treatment of patients with symptomatic gout. Lesinurad is an investigational agent that inhibits the URAT1 transporter, increasing uric acid excretion and thereby lowering serum uric acid. In the CLEAR1 and CLEAR2 trials, both lesinurad 200mg and 400mg in combination with allopurinol met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <6.0mg/dL at month 6 compared to allopurinol alone. In the CRYSTAL trial, lesinurad 400mg in combination with febuxostat met the primary endpoint, with a statistically significant higher proportion of patients reaching the target sUA goal of <5.0mg/dL at month 6 compared to febuxostat alone. Although lesinurad 200mg did not achieve statistical significance at month 6, this dose in combination with febuxostat, was superior to placebo plus febuxostat at all other time points. Results from these Phase III clinical trials will be submitted to a scientific meeting later in 2014. The company is proceeding with preparation of regulatory submissions for lesinurad 200mg combination therapy.
August 12, 2014
19:02 EDTMYGNOn The Fly: After Hours Movers
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16:11 EDTMYGNMyriad Genetics sees FY15 adjusted EPS $1.90-$2.00, consensus $2.12
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16:10 EDTMYGNMyriad Genetics reports Q4 adjusted EPS 48c, consensus 46c
Reports Q4 revenue $188.8M, consensus $187.68M.
15:23 EDTMYGNNotable companies reporting after market close
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05:58 EDTAZNStocks with implied volatility movement; P AZN
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August 7, 2014
06:13 EDTAZNDynavax says AZD1419 Phase 1 study met secondary endpoints
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August 6, 2014
09:19 EDTAZNShire, AstraZeneca, Smith & Nephew slump amid inversion fears, FT says
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