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News Breaks
May 9, 2014
16:02 EDTAMGN, AZNAmgen, AstraZeneca reports brodalumab study met primary, secondary endpoints
Amgen (AMGN) and AstraZeneca (AZN) announced that the Phase 3 AMAGINE-1 study evaluating brodalumab in patients with moderate-to-severe plaque psoriasis met all primary and secondary endpoints for both evaluated doses. Brodalumab is the only investigational treatment in development that binds to the interleukin-17 receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. Primary endpoints were patients achieving at least a 75% improvement from baseline in disease severity at week 12, as measured by the Psoriasis Area Severity Index, and patients achieving clear or almost clear skin at week 12 according to the static Physician Global Assessment.
News For AMGN;AZN From The Last 14 Days
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August 22, 2014
10:07 EDTAZNOptions with increasing implied volatility: ORPH EXAS AZN
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05:19 EDTAZNStocks with implied volatility movement; JRJC AZN
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August 21, 2014
09:54 EDTAZNPotential Pfizer, AstraZeneca deal seen around year-end, Reuters says
Investors and analysts see Pfizer (PFE) making another attempt to acquire AstraZeneca (AZN) around year-end, even though talks between the two can resume on August 26 per British takeover rules, Reuters reports. Reference Link
07:47 EDTAZNPfizer looking at new targets, including Actavis, Bloomberg reports
While it weighs another attempt to acquire AstraZeneca (AZN), Pfizer is considering other overseas alternatives, including Actavis (ACT), Bloomberg reports, citing people familiar with the matter. Pfizer prefers to reach a deal with AstraZeneca, and a move on another company is unlikely "anytime soon," Bloomberg adds, citing its sources. Shares of Actavis are rising 3%, or $6.65, to $230.01 in pre-market trading, while AstraZeneca is up 2% to $72.59. Reference Link
05:42 EDTAZNIllumina announces strategic partnership with AstraZeneca, Sanofi, Janssen
Illumina (ILMN) announced it has formed collaborative partnerships with leading pharmaceutical companies to develop a universal next-generation sequencing, or NGS,-based oncology test system. The system will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection, resulting in a more comprehensive tool for precision medicine. Initial strategic partners include AstraZeneca (AZN), Janssen Biotech, a Johnson & Johnson (JNJ) company, and Sanofi (SNY). Illumina is working with the strategic partners to develop assays that detect and measure multiple variants simultaneously to support partners’ clinical trials, with the objectives of securing regulatory agency approvals and test commercialization. In parallel, Illumina is working with key thought leaders to set standards for NGS-based assays in routine clinical oncology practice, as well as to define regulatory frameworks to enable this new testing paradigm. Together, Illumina and its strategic partners aim to transition from single-analyte companion diagnostics to panel-based assays that select for “companion therapeutics.”
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.
05:11 EDTAMGNGamida Cell announces investment, option agreement with Novartis
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August 18, 2014
17:25 EDTAMGNAmgen announces AMG 416 study met its primary and all secondary endpoints
Amgen announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism, SHPT, in patients with chronic kidney disease,CKD, receiving hemodialysis, met its primary and all secondary endpoints. "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with hemodialysis. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."
07:57 EDTAZNCambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 15, 2014
06:54 EDTAMGNAmgen shares should 'grind higher' this year, says RBC Capital
RBC Capital expects Amgen shares to "grind higher" this year driven by a greater appreciation of pipeline programs, the Analyst Day on October 28, an expected filing of the PCSK-9 program soon, and positive Ph iiB anti-CGRP migraine data expected year-end. Shares are Outperform rated.
August 14, 2014
12:01 EDTAMGN, AZNThird 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).
11:52 EDTAMGNThird Point discloses new stakes in Finisar, Amgen, Ally Financial
August 13, 2014
18:55 EDTAMGNOn The Fly: After Hours Movers
UP AFTER EARNINGS: Aspen Technology (AZPN), up almost 3% after reporting better than expected Q4 results and giving Q1 and FY15 guidance on its earnings conference call. ALSO HIGHER: Kindred Healthcare (KND), up more than 1% after Point72 reported a 5.1% passive stake in the company. DOWN AFTER EARNINGS: Cisco Systems (CSCO), down 1.2% after reporting Q4 results, giving Q1 guidance, and announcing that it is cutting 8% of its workforce... Noodles & Company (NDLS), down 21.2% after reporting Q2 results and "tempering" its FY14 outlook... Conatus Pharmaceuticals (CNAT), down 13.6% after reporting Q2 results and announcing it is deferring the results of its NAFLD/NASH clinical trial to 1Q15. ALSO LOWER: Amgen (AMGN), down 2.15% after announcing the Phase 3 Kyprolis FOCUS clinical trial did not meet its primary endpoint.
16:17 EDTAMGNAmgen issues voluntary recall of Aranesp prefilled syringes in several countries
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16:09 EDTAMGNAmgen slips lower after hours, levels to watch
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16:04 EDTAMGNAmgen says Phase 3 clinical trial FOCUS did not meet primary endpoint
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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
05:58 EDTAZNStocks with implied volatility movement; P AZN
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