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Amgen Inc (AMGN.O)

AMGN.O on Nasdaq

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22 Sep 2017
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Latest Key Developments (Source: Significant Developments)

U.S. FDA approved Amgen's Mvasi as a biosimilar to Avastin
Thursday, 14 Sep 2017 12:31pm EDT 

Sept 14 (Reuters) - U.S. FDA :U.S. FDA says approved Amgen's Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer.‍U.S. FDA says Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers​.  Full Article

Adello Biologics says FDA accepts for review co's Biologics License Application for proposed filgrastim biosimilar
Monday, 11 Sep 2017 12:30pm EDT 

Sept 11 (Reuters) - Adello Biologics::FDA accepts Adello Biologic's biosimilar biologics license application for a proposed filgrastim biosimilar.U.S. FDA has accepted for review co's Biologics License Application (BLA) for a biosimilar candidate referencing neupogen (filgrastim)​.  Full Article

Temasek Holdings takes stake in JPMorgan, Biogen, Celgene
Monday, 14 Aug 2017 09:05am EDT 

Aug 14 (Reuters) - Temasek Holdings (Private) Ltd::Temasek Holdings (Private) Ltd takes share stake in JPMorgan Chase & Co of 264,337 shares.Temasek Holdings takes share stake in Biogen Inc of 95,226 shares - SEC filing.Temasek Holdings takes share stake of 206,187 shares in Celgene Corp.Temasek Holdings takes share stake of 151,310 shares in Amgen Inc.Temasek Holdings ups share stake in Royal Dutch Shell Plc to 2.4 million class B sponsored ADR shares from 408,543 class B sponsored ADR shares.Temasek Holdings ups share stake in Regeneron Pharmaceuticals by 40.5 percent to 177,553 shares.Temasek Holdings : change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017.  Full Article

Cytokinetics announces positive results from phase 2 trial of Omecamtiv Mecarbil
Wednesday, 2 Aug 2017 07:30am EDT 

Aug 2 (Reuters) - Cytokinetics Inc ::Cytokinetics announces positive results from phase 2 clinical trial of Omecamtiv Mecarbil in Japanese patients with heart failure.Cytokinetics announces positive results from phase 2 clinical trial of Omecamtiv Mecarbil in Japanese patients with heart failure.Cytokinetics inc - ‍company is eligible to earn $10 million milestone payment from amgen upon first patient dosing in Japan in phase 3 outcomes trial​.Cytokinetics inc - ‍phase 2 clinical trial of Omecamtiv Mecarbil in Japanese patients with heart failure has met its pharmacokinetic primary endpoint​.Cytokinetics inc - ‍phase 2 clinical trial demonstrated statistically significant improvements in systolic ejection time (set), a secondary endpoint​.Cytokinetics inc - ‍cytokinetics is eligible to earn a $10 million milestone payment from amgen upon first dosing of a patient in Japan in Galactic-Hf​.  Full Article

Amgen submits supplemental biologics license application for Prolia in glucocorticoid-induced osteoporosis
Monday, 31 Jul 2017 09:10am EDT 

July 31 (Reuters) - Amgen Inc :Amgen submits supplemental biologics license application for Prolia® (denosumab) in glucocorticoid-induced osteoporosis.Amgen Inc - ‍Submission of a supplemental biologics license application to U.S. Food and Drug Administration for Prolia​.Amgen - Results from phase 3 study in SBLA submission showed treatment with Prolia for 12 months led to statistically significant greater gains in BMD.Amgen- ‍SBLA based on a phase 3 study evaluating safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment​.Amgen Inc - Adverse events and serious adverse events (SAES) were similar across treatment groups and consistent with known safety profile of Prolia.  Full Article

Amgen and Allergan submit biosimilar Biologics License application for ABP 980 to U.S. FDA
Monday, 31 Jul 2017 09:00am EDT 

July 31 (Reuters) - Amgen Inc :Amgen and Allergan submit biosimilar Biologics License Application for ABP 980 to US Food and Drug Administration.Amgen - Co and Allergan are collaborating on four oncology biosimilar medicines, including ABP 980 which is second to be submitted for FDA approval​.  Full Article

FDA grants priority review for Amgen's supplemental biologics license application for Repatha
Thursday, 27 Jul 2017 05:50pm EDT 

July 27 (Reuters) - Amgen Inc :FDA grants priority review for Amgen's supplemental biologics license application for Repatha® (evolocumab) to include data on reducing risk of cardiovascular events.Amgen Inc - ‍FDA has set a prescription drug user fee act (PDUFA) action date of Dec. 2, 2017. for Repatha​.Amgen Inc - Second application seeking to expand lipid-lowering indication to include additional patient populations studied was also accepted by FDA.  Full Article

Amgen Q2 GAAP shr $2.91
Tuesday, 25 Jul 2017 04:01pm EDT 

July 25 (Reuters) - Amgen Inc :Amgen reports second quarter 2017 financial results.Q2 revenue $5.8 billion versus i/b/e/s view $5.67 billion.Q2 non-gaap earnings per share $3.27.Q2 gaap earnings per share $2.91.Sees fy 2017 revenue $22.5 billion to $23 billion.Q2 earnings per share view $3.11 -- Thomson Reuters I/B/E/S.Sees q3 2017 non-gaap earnings per share $12.15 to $12.65.Sees fy 2017 gaap earnings per share $10.79 to $11.37.  Full Article

Amgen Q2 GAAP shr $2.91
Tuesday, 25 Jul 2017 04:01pm EDT 

July 25 (Reuters) - Amgen Inc :Q2 gaap earnings per share $2.91; q2 non-gaap earnings per share $3.27; q2 total revenue $5.81 billion versus $5.69 billion.Amgen - 2017 eps outlook increased to $10.79-$11.37 on gaap basis, $12.15-$12.65 on non-gaap basis; 2017 revenue outlook revised to $22.5 billion-$23 billion.Q2 earnings per share view $3.11, revenue view $5.67 billion -- Thomson Reuters I/B/E/S.Says expects 2017 capital expenditures to be approximately $700 million.Fy2017 earnings per share view $12.48, revenue view $22.69 billion -- Thomson Reuters I/B/E/S.  Full Article

Amgen says FDA accepts biologics license application for Aimovig
Thursday, 20 Jul 2017 04:30pm EDT 

July 20 (Reuters) - Amgen Inc :FDA accepts biologics license application for Aimovig™ (erenumab).Amgen Inc - FDA has set a prescription drug user fee act (PDUFA) target action date of May 17, 2018..Amgen Inc - Aimovig will be jointly commercialized in U.S. by Amgen and Novartis..  Full Article

U.S. FDA approves biosimilar version of cancer drug Avastin

The U.S. Food and Drug Administration said on Thursday it has approved Amgen Inc's biosimilar version of Roche Holding AG's cancer drug Avastin.