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June 11, 2014
17:19 EDTAZN, AMGNAmgen says Phase 2 study of brodalumab met primary endpoint
Amgen (AMGN) and AstraZeneca (AZN) announced that results from a Phase 2 study evaluating brodalumab in 168 patients with psoriatic arthritis were published in The New England Journal of Medicine. These data will also be presented at the 2014 European League Against Rheumatism Annual Congress in Paris on June 14.. 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. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes. The study showed that treatment with brodalumab significantly improved signs and clinical symptoms associated with the disease, including tender and swollen joints, at 12 weeks as measured by a 20% improvement in the American College of Rheumatology response criteria. The study also showed that many patients continued to improve, and that the improvements were sustained, through the first 52 weeks of the study reported in NEJM. The study achieved its primary endpoint with both doses of brodalumab exhibiting superiority to placebo in ACR20 responses at week 12. These responses continued to improve through 24 weeks and were sustained through the first 52 weeks of the study.1 ACR response criteria are a measure of improvement in tender and swollen joints, as well as patient and physician global assessments of disease activity, pain, disability and inflammatory markers. A 20% improvement from baseline in ACR response rates is known as ACR20, a 50% improvement from baseline is known as ACR50 and a 70% improvement from baseline is known as ACR70.
News For AMGN;AZN From The Last 14 Days
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January 27, 2015
17:00 EDTAMGNAmgen Q4 Enbrel sales grew 19% quarter over quarter
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16:15 EDTAMGNAmgen submits applications in US and Europe for Kyprolis
Amgen and its subsidiary Onyx Pharmaceuticals announced the submission of a supplemental New Drug Application,sNDA to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency for Kyprolis for Injection to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. In the U.S., the sNDA is designed to support the conversion of accelerated approval to full approval and expand the current approved indication. In the European Union, Kyprolis received orphan drug designation and the MAA has been granted accelerated assessment. The sNDA and MAA are based on data from the Phase 3 ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial and other relevant data. "Multiple myeloma is an incurable blood cancer that often becomes resistant to treatment, underscoring the need for new therapeutic options that provide deep and durable responses to extend the time patients live without their disease progressing," said Pablo J. Cagnoni, M.D., president, Onyx Pharmaceuticals, Inc. "The U.S. and EU submissions support our goal of bringing Kyprolis to patients with relapsed multiple myeloma."
16:06 EDTAMGNAmgen trades higher after hours, levels to watch
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16:04 EDTAMGNAmgen backs FY15 EPS view $9.05-$9.40, consensus $9.29
Backs FY15 revenue view $20.8B-$21.3B, consensus $20.87B.
16:03 EDTAMGNAmgen reports Q4 EPS $2.16, consensus $2.05
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15:35 EDTAMGNNotable companies reporting after market close
Notable companies reporting after the market close, with earnings consensus, include Apple (AAPL), consensus $2.60; AT&T (T), consensus 55c; Amgen (AMGN), consensus $2.05; Yahoo (YHOO), consensus 29c; ACE (ACE), consensus $2.29; Stryker (SYK), consensus $1.45; Western Digital (WDC), consensus $2.10; Electronic Arts (EA), consensus 92c; Juniper (JNPR), consensus 31c; Total System Services (TSS), consensus 53c; Freescale Semiconductor (FSL), consensus 33c; Amdocs (DOX), consensus 81c; VMware (VMW), consensus $1.07; International Game Technology (IGT), consensus 25c; United States Steel (X), consensus 87c; Cytec (CYT), consensus 61c.
12:57 EDTAMGNEarnings Preview: Amgen's Kyprolis, Prolia sales key for Q4 results
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12:54 EDTAZNBox, Inc. lands AstraZeneca contract to service 51,000 users, Re/code reports
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January 26, 2015
15:24 EDTAZNTeva confirms U.S. approval of AstraZeneca's Nexium generic
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January 21, 2015
12:30 EDTAZNGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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10:16 EDTAMGN, AZNLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 15, 2015
16:04 EDTAMGNAmgen announces new data from Phase 2 PEAK, Phase 3 PRIME studies
Amgen announced new data from the Phase 2 PEAK and Phase 3 PRIME studies that support the first-line use of Vectibix in combination with Folfox, an oxaliplatin-based chemotherapy regimen, in patients with wild-type RAS metastatic colorectal cancer. In an exploratory analysis from the PEAK study, treatment with Vectibix compared to Avastin resulted in a "significantly higher proportion" of patients with earlier tumor shrinkage at week eight, 64% vs. 45%, respectively, and among responding patients, a longer duration of response, 11.4 vs. 8.5 months, respectively, and greater depth of response . Overall response rates appeared to be similar between Vectibix and Avastin. This is consistent with observed overall survival and progression-free survival (PFS) rates, and with data previously reported, Amgen said. It added, "While the primary analysis from PEAK showed similar ORR between the Vectibix- and bevacizumab-based regimens, this exploratory analysis demonstrates that Vectibix produces early, sustained anti-tumor activity, which may in part explain the OS and PFS benefits seen with Vectibix versus bevacizumab in this trial."
07:59 EDTAMGNAmerican Society of Clinical Oncology to hold a symposium
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January 14, 2015
07:37 EDTAZNJPMorgan to hold a conference
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07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
AstraZeneca announced that the PEGASUS-TIMI 54 study, a large scale outcomes trial involving over 21,000 patients, successfully met its primary efficacy endpoint. The study assessed BRILINTA tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular death, myocardial infarction or stroke. Preliminary analysis did not reveal any unexpected safety issues. Full evaluation of the data is ongoing. The PEGASUS-TIMI 54 study investigated two different doses of ticagrelor on a background of low dose aspirin versus placebo plus low dose aspirin, in patients aged 50 and older with a history of heart attack and one additional CV risk factor. The study was designed to better understand the management of patients more than 12 months after their heart attack, who remain at high risk for major thrombotic events. Complete results from the PEGASUS-TIMI 54 study will be submitted to a scientific meeting in 2015 and pending further analysis, AstraZeneca plans to file this data with regulatory health authorities. The PEGASUS-TIMI 54 study is part of AstraZeneca’s PARTHENON program. The PLATO study, involving over 18,000 ACS patients, was the first study in the program and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are investigating ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis. BRILINTA is not approved for secondary prevention of atherothrombotic events in patients with a history of heart attack beyond one year or for the prevention of cardiovascular events in patients with PAD, stroke, diabetes or atherosclerosis.
07:03 EDTAZNAstraZeneca says Pegasus-TIMI 54 study met primary efficacy endpoint
January 13, 2015
12:55 EDTAMGNAmgen repeats FY15 adjusted EPS view $9.05-$9.40, consensus $9.29
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12:40 EDTAMGNAmgen off highs after Express Scripts CEO talks PCSK9 costs
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07:42 EDTAMGNJPMorgan to hold a conference
33rd Annual Healthcare Conference is being held in San Francisco on January 12-15 with webcasted company presentations to begin on January 13 at 10:30 am; not all company presentations may be webcasted. Webcast Link

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