$AMGN (Amgen Inc)

$AMGN {{ '2015-08-07T16:39:50+0000' | timeago}} • SEC

$AMGN Form 4: Fred Hassan, Director, acquired 572 of common stock as dividend equivalent rights on August 4, 2015. Post-transaction, Paul now owns 572 of common stock.

$AMGN {{ '2017-09-14T19:26:48+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi for the treatment of five types of cancer. Amgen and Allergan's bevacizumab biosimilar is also undergoing review by the European Medicines Agency, following a Marketing Authorization Application submitted in December 2016.

$AMGN {{ '2017-09-14T19:26:21+0000' | timeago}} • Announcement

$AMGN and $AGN said the FDA has approved their Mvasi (bevacizumab-awwb) for the treatment of five types of cancer. The approval was based on totality of evidence from global development program showing Mvasi is highly similar to Avastin. Mvasi is the first anti-cancer biosimilar, as well as first bevacizumab biosimilar, approved by the FDA.

$AMGN {{ '2017-09-07T20:44:44+0000' | timeago}} • Announcement

$AMGN's new data demonstrates Aimovig reducing monthly migraine days for patients with chronic migraine and prior treatment failure, a population with significant unmet meed. Aimovig is the only investigational biologic product specifically designed to prevent migraine by blocking the CGRP receptor, which is associated with migraine activation.

$AMGN {{ '2017-09-07T12:11:23+0000' | timeago}} • Announcement

$AMGN announced results from the PATHWAY Phase 2b trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. Tezepelumab is a novel anti-thymic stromal lymphopoietin monoclonal antibody being developed by $AZN in collaboration with $AMGN.

$AMGN {{ '2017-08-29T20:44:23+0000' | timeago}} • Announcement

$AMGN announced that a new analysis showed lowering low-density lipoprotein cholesterol levels with Repatha reduced the risk of cardiovascular events in a sub-group of patients with a history of stroke from the Repatha cardiovascular outcomes study.

$AMGN {{ '2017-07-31T13:27:43+0000' | timeago}} • Announcement

$AMGN and $AGN announced the submission of a Biologics License Application (BLA) to the FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab). These two companies are collaborating on four oncology biosimilar medicines, including ABP 980 which is the second to be submitted for FDA approval.

$AMGN {{ '2017-07-31T13:23:05+0000' | timeago}} • Announcement

$AMGN has submitted a supplemental Biologics License Application (sBLA) to the FDA for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis. The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.

$AMGN {{ '2017-07-28T21:32:52+0000' | timeago}} • Announcement

$AMGN's BoD declared 3Q17 dividend of $1.15 per share. The dividend is payable on Sept. 8, 2017 to stockholders of record on Aug. 17, 2017.

$AMGN {{ '2017-07-28T19:57:07+0000' | timeago}} • Announcement

FDA granted priority review for $AMGN's supplemental Biologics License Application (sBLA) for Repatha (evolocumab), a PCSK9 inhibitor, to include risk reduction of major cardiovascular events. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017.

$AMGN {{ '2017-07-26T19:57:57+0000' | timeago}} • Webcast

$AMGN has $39Bil cash on balance sheet, with no intention to consummate M&A transactions or repaying debt right now. The vast majority of cash is sitting offshore and the company is not considering to repatriate it under the current US tax system. The company said it will take a look at deploying the cash when some progress is made on tax reform.

$AMGN {{ '2017-07-26T19:34:18+0000' | timeago}} • Webcast

In 2Q17, $AMGN had a strong volume-driven growth from Prolia and other recently launched drugs including KYPROLIS and Repatha. Prolia sales increased 15% with an 18% volume growth YoY, with share gains in both the US and international markets.

$AMGN {{ '2017-07-25T22:44:31+0000' | timeago}} • Announcement

$AMGN increased its 2017 earnings guidance to between $10.79 per share and $11.37 per share on GAAP basis, and between $12.15 per share and $12.65 per share on adjusted basis. Sales guidance was revised to a range of $22.5-23Bil.

$AMGN {{ '2017-07-25T22:43:15+0000' | timeago}} • Announcement

$AMGN reported a 15% YoY earnings growth in 2Q17 to $2.2Bil, or $2.91 per share, driven by a 4.9 percentage points increase in operating margin. Adjusted for one-time items, the company reported per-share earnings of $3.27. Revenue rose 2% to $5.8Bil.

$AMGN {{ '2017-07-25T20:50:47+0000' | timeago}} • Infographic

$AMGN Amgen Earnings AlphaGraphic: Q2 2017 highlights

$AMGN {{ '2017-07-18T15:11:19+0000' | timeago}} • Announcement

$AMGN and $ARRY collaborates for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered through Array's proprietary platform. Amgen, responsible for clinical development & commercialization, will make upfront and milestone payments for rights to Array's preclinical program.

$AMGN {{ '2017-07-14T16:06:47+0000' | timeago}} • Announcement

$AMGN announced the submission of a supplemental New Drug Application to the FDA and a variation to the marketing application to the European Medicines Agency to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS (carfilzomib).

$AMGN {{ '2017-07-13T12:24:26+0000' | timeago}} • Announcement

$AMGN and $AGN announced they will discuss data supporting the ABP 215 Biologics License Application (BLA) with FDA's Oncologic Drugs Advisory Committee. ABP 215 is a biosimilar candidate to Avastin (bevacizumab) and is the first bevacizumab biosimilar candidate to be considered by the FDA.

$AMGN {{ '2017-07-12T20:58:00+0000' | timeago}} • Announcement

$AMGN said the final analysis of its phase-3 ASPIRE trial involving myeloma patients met the key secondary endpoint of overall survival. The study demonstrated Kyprolis reduced the risk of death by 21%, compared to lenalidomide and dexamethasone. The data will be submitted to regulatory agencies to support a potential label update.

$AMGN {{ '2017-07-12T11:38:47+0000' | timeago}} • Announcement

$AMGN said the FDA has approved the supplemental Biologics License Application for Blincyto to include overall survival data from the Phase 3 Tower study. This also included data from Phase 2 Alcantara study supporting treatment of Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

$AMGN {{ '2017-06-30T10:59:07+0000' | timeago}} • Announcement

$AMGN announced that the FDA has approved its Vectibix for patients with colorectal cancer, following successful Phase 3 trials.

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