Key Developments: Amgen Inc (AMGN.O)

AMGN.O on Nasdaq

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19 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Amgen Inc raises FY 2014 outlook
Monday, 27 Oct 2014 04:01pm EDT 

Amgen Inc:Expects FY 2014 total revenues to be in the range of $19.8 billion to $20.0 billion.Expects FY 2014 adjusted EPS to be in the range of $8.45 to $8.55.FY 2014 revenue of $19.7 billion and EPS of $8.42 - Thomson Reuters I/B/E/S.  Full Article

Amgen Inc announces 2014 fourth quarter dividend
Friday, 17 Oct 2014 04:03pm EDT 

Amgen Inc:Declares $0.61 per share dividend for fourth quarter of 2014.Dividend will be paid on Dec. 5 to all stockholders of record as of close of business on Nov. 13.  Full Article

Amgen Inc files lawsuit against Sanofi And Regeneron for patent infringement
Friday, 17 Oct 2014 09:00am EDT 

Amgen Inc:Says that it filed a lawsuit in the United States District Court of Delaware against Sanofi, Aventisub LLC, formerly doing business as Aventis Pharmaceuticals Inc, and Regeneron Pharmaceuticals Inc for patent infringement of U.S. Patent Numbers 8,563,698, 8,829,165, and 8,859,741.These patents, which are owned by Amgen, describe and claim monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9).  Full Article

Amgen Inc's BiTE immunotherapy blinatumomab receives FDA priority review designation in acute lymphoblastic leukemia
Thursday, 9 Oct 2014 04:05pm EDT 

Amgen Inc:Announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for the investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab.Says the BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.1As part of the acceptance, the FDA granted blinatumomab priority review with a Prescription Drug User Fee Act (PDUFA) action date of May 19, 2015.Says a Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) via the centralized procedure for approval to market blinatumomab for the treatment of adults with Ph- relapsed/refractory B-precursor ALL.  Full Article

Amgen announces positive top-line results from phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with adalimumab
Wednesday, 8 Oct 2014 09:15am EDT 

Amgen Inc:Announced its Phase 3 study evaluating efficacy and safety of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.Says the primary endpoint was the Psoriasis Area and Severity Index (PASI) percent improvement from baseline to week 16 of treatment.At week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab. Safety and immunogenicity of ABP 501 were comparable to adalimumab.  Full Article

Amgen Inc publishes two phase 3 studies showing cholesterol-lowering medication evolocumab significantly reduced LDL cholesterol
Wednesday, 1 Oct 2014 07:15pm EDT 

Amgen Inc:Says that the Lancet publishes two phase 3 studies showing cholesterol lowering medication evolocumab significantly reduced LDL cholesterol in patients with serious genetic disorders.Says that cause high cholesterol data from phase 3 RUTHERFORD-2 study show evolocumab significantly reduced mean LDL-C by 59-66 Percent compared to placebo in patients with heterozygous familial hypercholesterolemia.Says phase 3 TESLA data show evolocumab significantly reduced LDL-C by 31 Percent compared to placebo in patients with homozygous familial hypercholesterolemia.  Full Article

UCB and Amgen announce results from several exploratory analyses of Phase 2 study of romosozumab
Tuesday, 16 Sep 2014 01:00am EDT 

UCB SA:Announces together with Amgen results from several exploratory analyses of Phase 2 study of romosozumab.Says romosozumab evaluated in postmenopausal women with low bone mineral density (BMD).Says results from one analysis showed that treatment with romosozumab led to significant increases in lumbar spine and total hip BMD.Says results of romosozumab Phase 3 program expected in 2016.  Full Article

Amgen Inc presents analyses of Phase 3 Ivabradine data for treatment Of chronic heart failure
Sunday, 14 Sep 2014 04:00pm EDT 

Amgen Inc:Announces data from the Phase 3 SHIFT study evaluating ivabradine in patients with chronic heart failure were presented.Says a post-hoc analysis from the SHIFT study confirmed low systolic blood pressure (SBP) is associated with poor outcomes in chronic HF, and that ivabradine reduced the primary composite endpoint of cardiovascular death or hospitalization for worsening HF in this subgroup with low baseline SBP.Says safety was similar across the three SBP groups.  Full Article

Amgen Inc submits marketing authorization application for novel investigational LDL Cholesterol-Lowering Medication Evolocumab to European Medicines Agency
Tuesday, 2 Sep 2014 08:00am EDT 

Amgen Inc:Says submission of Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via centralized procedure for evolocumab seeking approval for treatment of high cholesterol.Says Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or 'bad' cholesterol, from the blood.Says MAA for evolocumab contains data from about 6,800 patients, including more than 4,500 patients with high cholesterol in 10 Phase 3 trials.Says phase 3 studies evaluated the safety and efficacy of evolocumab in patients with elevated cholesterol on statins with or without other lipid-lowering therapies.Says patients who cannot tolerate statins, patients with heterozygous familial hypercholesterolemia (HeFH) and patients with homozygous familial hypercholesterolemia (HoFH), a rare and serious genetic disorder.  Full Article

Amgen Inc announces positive top-line results from phase 3 YUKAWA-2 Trial of evolocumab in combination with statins in Japanese patients with high cardiovascular risk and high cholesterol
Thursday, 28 Aug 2014 09:15am EDT 

Amgen Inc:Says phase 3 YUKAWA-2 study evaluating evolocumab in combination with statin therapy in Japanese patients with high cardiovascular risk and high cholesterol met its co-primary endpoints.Says percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12.Says percent reduction in LDL-C, or "bad" cholesterol, was clinically meaningful, statistically significant, and consistent with the results observed for the same doses in the Phase 2 YUKAWA trial for evolocumab compared to placebo.Says evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.Says YUKAWA-2 trial evaluated safety, tolerability and efficacy of evolocumab compared to placebo in combination with statin therapy in 404 Japanese patients with high cardiovascular risk and high cholesterol.Says patients were randomized to one of eight treatment groups to compare subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) with subcutaneous placebo (every two weeks or monthly) when added to different daily doses of atorvastatin.  Full Article

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Exclusive: Amgen's new leukemia drug to carry $178,000 price tag

- Amgen Inc on Wednesday said its new type of treatment for a deadly form of leukemia would cost about $178,000 when it becomes available on Thursday, which would make it one of the world's most expensive cancer drugs.

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