$AMGN (Amgen Inc)

$AMGN {{ '2016-07-05T04:35:54+0000' | timeago}} • Announcement

The EC approved the extended indication for $AMGN's Kyprolis based on data from Phase 3 head-to-head ENDEAVOR trial in which patients with multiple myeloma treated with Kyprolis plus dexamethasone achieved progression-free survival of 18.7 months versus 9.4 months in those receiving bortezomib plus dexamethasone.

$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.

$AMGN {{ '2017-06-05T12:46:28+0000' | timeago}} • Announcement

Biotech firm $AMGN said its phase-2 '264 study met the primary endpoint. The trial revealed that Imlygic, a viral therapy for tumor, in combination with immune checkpoint inhibitor Yervoy more than doubled the proportion of patients with tumor size reduction, compared to Yervoy alone, in persons with unresectable stage IIIB-IV melanoma.

$AMGN {{ '2017-05-18T13:38:23+0000' | timeago}} • Announcement

$AMGN submitted a Biologics License Application to the FDA for erenumab to prevent migraine. The erenumab global clinical trial program has enrolled more than 2,600 patients experiencing four or more migraine days per month.

$AMGN {{ '2017-04-26T22:47:02+0000' | timeago}} • Webcast

$AMGN believes that its cholesterol lowering drug Repatha to be an important product in the cardiovascular area. In 1Q17, the company achieved positive results for XGEVA drug. Subject to regulatory approvals, $AMGN looks forward to offer this therapy to multiple myeloma patients, many of whom are at risk of skeletal-related events.

$AMGN {{ '2017-04-26T20:46:39+0000' | timeago}} • Announcement

For FY17, $AMGN now sees total revenues at $22.3-23.1Bil, with GAAP EPS at $10.64-11.32 and a tax rate in the range of 16-18%. Capex is touted to be about $700MM for the year. Amgen also expects full-year non-GAAP EPS to be $12.00-12.60.

$AMGN {{ '2017-04-26T20:42:42+0000' | timeago}} • Announcement

In 1Q17, total operating expenses for $AMGN fell 8%, cost of sales margin improved 0.2 percentage points, R&D expenses shed 12%, and Selling, General & Administrative (SG&A) expenses slid another 12%. Amgen generated $2.2Bil of free cash flow vs. $1.8Bil last year.

$AMGN {{ '2017-04-26T20:42:13+0000' | timeago}} • Announcement

$AMGN's revenue slipped 1% to $5.46Bil in 1Q17, as it posted a 9% bump in net income of $2.07Bil from last year's $1.90Bil. Earnings rose 12% to $2.79 per diluted share, as Amgen recorded a 4 percentage-point improvement in operating margin of 49.8%.

$AMGN {{ '2017-04-26T20:37:49+0000' | timeago}} • Infographic

$AMGN Amgen Inc. Earnings AlphaGraphics: Q1 2017 highlights

$CUZ {{ '2017-03-28T12:26:54+0000' | timeago}} • Announcement

$CUZ announced that $AMGN signed a 10-year lease at Corporate Center in the Westshore submarket of Tampa, FL. Amgen plans to open its new Tampa location in late 2017.

$AMGN {{ '2017-03-23T20:27:49+0000' | timeago}} • Announcement

$AMGN announced that European Commission has approved AMGEVITA, which is authorized for the treatment of certain inflammatory diseases in adults. Approval from the EC grants $AMGN a centralized marketing authorization in the 28 countries that are members of the EU.

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