$AMGN (Amgen Inc)

$AMGN {{ '2015-07-24T17:43:37+0000' | timeago}} • Announcement

$AMGN, Amgen today announced that the U.S. Food and Drug Administration approved the supplemental new drug application (sNDA) for Kyprolis (carfilzomib) for Injection in combination with Revlimid (lenalidomide) and dexamethasone (KRd) for the treatment of patients with multiple myeloma who have received one to three prior lines of therapy

$AMGN {{ '2017-10-17T14:34:06+0000' | timeago}} • Announcement

$AMGN has entered into a neuroscience research collaboration with Boston Children's Hospital, which aims at identifying novel pain targets based on human genetic analyses. The one-year collaboration will focus on patients with genetic anomalies of pain sensitivity.

$AMGN {{ '2017-10-05T21:56:58+0000' | timeago}} • Announcement

$AMGN said first randomized study to evaluate Imlygic (talimogene laherparepvec), an oncolytic viral therapy, in combination with a checkpoint inhibitor published in the Journal of Clinical Oncology. The study met its primary endpoint of objective response rate. Imlygic is designed to rupture cancer cells causing release of tumor-derived antigens.

$REGN {{ '2017-10-05T17:28:07+0000' | timeago}} • Announcement

Sanofi and $REGN said the U.S. Court of Appeals for the Federal Circuit has ordered new trial and vacated permanent injunction in the dispute concerning $AMGN's asserted patent claims for antibodies targeting PCSK9. This ruling means that Sanofi and $REGN will continue marketing, selling and manufacturing Praluent (alirocumab) injection in the U.S.

$AMGN {{ '2017-10-03T20:40:22+0000' | timeago}} • Announcement

$AMGN and $CTMX said they will co-develop a Probody T-cell engaging bispecific against EGFRxCD3 with CytomX leading early development. $AMGN will make an upfront payment of $40MM and purchase $20MM of $CTMX common stock.

$AMGN {{ '2017-10-03T20:38:44+0000' | timeago}} • Announcement

$AMGN and $CTMX entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX Probody T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types.

$AMGN {{ '2017-09-26T20:20:34+0000' | timeago}} • Announcement

$AMGN and Simcere Pharmaceutical Group team up to co-develop and commercialize four biosimilars in China. The collaboration includes undisclosed biosimilars in the areas of inflammation and oncology. Amgen will remain responsible for the co-development, marketing approval applications and manufacturing of the biosimilars.

$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

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