$AMGN (Amgen Inc)

$AMGN {{ '2016-04-28T22:15:27+0000' | timeago}} • Webcast

$AMGN said BLINCYTO continues to increase patient penetration in the US and launches are underway across Europe as reimbursement is secured. IMLYGIC is currently indicated as monotherapy in the US and Europe and is playing an important role in addressing the need for the small patient population.

$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.

$AMGN {{ '2017-06-23T20:25:55+0000' | timeago}} • Announcement

$AMGN said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the Marketing Authorization of a pediatric formulation of Mimpara (cinacalcet). This is for the treatment of secondary hyperparathyroidism (HPT) in children aged three years and older with end‑stage renal disease.

$AMGN {{ '2017-06-19T13:13:35+0000' | timeago}} • Announcement

$AMGN said the FDA has accepted Xgeva (denosumab) supplemental Biologics License Application that seeks to expand currently approved indication for prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include multiple myeloma patients. The FDA has set a PDUFA action date of Feb. 3, 2018.

$AMGN {{ '2017-06-09T09:16:25+0000' | timeago}} • Announcement

$AMGN said it will present 19 scientific abstracts at the 59th Annual Scientific Meeting of the American Headache Society, to be held from June 8 to 11 in Boston. The focus will be on a new analysis from recent clinical studies highlighting the efficacy of erenumab, a drug for acute migraine.

$AMGN {{ '2017-06-07T14:18:46+0000' | timeago}} • Announcement

$AMGN and $AGN said that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Biologics License Application (BLA) for ABP 215, a biosimilar candidate to Avastin (bevacizumab), on July 13, 2017. Bevacizumab is medication used to treat types of cancers and specific eye disease.

$AMGN {{ '2017-06-05T12:59:50+0000' | timeago}} • Announcement

$AMGN said its phase-3 '482 study on bone metastases drug Xgeva met its primary endpoint, demonstrating it is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. The study showed that patients on Xgeva had lower rate of renal adverse events compared to zoledronic acid.

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