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March 28, 2014
07:39 EDTCYTK, AMGNCytokinetics announces opening to enrollment of COSMIC-HF expansion
Cytokinetics (CYTK) announced that the expansion phase of the Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure, or COSMIC-HF, has opened to enrollment. COSMIC-HF is a Phase II double-blind, randomized, placebo-controlled, multicenter clinical trial designed to assess the pharmacokinetics and tolerability of omecamtiv mecarbil dosing orally in patients with heart failure and left ventricular systolic dysfunction. The expansion phase of COSMIC-HF will enroll approximately 450 patients randomized 1:1:1 to receive placebo, 25 mg, or 50 mg twice daily of omecamtiv mecarbil. Escalation to the 50 mg dose will depend on the plasma concentration of omecamtiv mecarbil following two weeks of oral dosing at 25 mg twice daily. The primary objective of the expansion phase of this trial is to characterize the safety, tolerability, and pharmacokinetics of omecamtiv mecarbil dosed orally during 20 weeks of treatment. The secondary objectives are to assess the changes from baseline in systolic ejection time, stroke volume, left ventricular end-systolic diameter, left ventricular end-diastolic diameter, heart rate and N-terminal pro-brain natriuretic peptide during 20 weeks of treatment. The expansion phase of COSMIC-HF is expected to enroll heart failure patients from approximately 100 clinical sites internationally. COSMIC-HF is being conducted by Amgen (AMGN) in collaboration with Cytokinetics. Amgen holds an exclusive, worldwide license to develop and commercialize omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization participation rights.
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July 30, 2014
18:02 EDTAMGNAmgen shares could gain 25%, Barron's says
Amgen shares could see a 25% gain driven by the company's guidance and restructuring, Barron's argues in its "Barron's Take" column. The stock also has a 1.9% dividend yield, the paper adds. Reference Link
17:12 EDTAMGNOn The Fly: Closing Wrap
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16:10 EDTCYTKCytokinetics reports Q2 EPS (23c), consensus (32c)
Reports Q2 revenue $7.8M, consensus $7.01M.
09:38 EDTAMGNActive equity options trading on open
Active equity options trading on open according to Track Data: AAPL AMZN TWTR NFLX GILD C MA FB RFMD AMGN GNW TSLA
09:04 EDTAMGNOn The Fly: Pre-market Movers
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07:04 EDTAMGNAmgen price target raised to $138 from $125 at RBC Capital
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06:16 EDTAMGNOptions expected to be active: TWTR BWLD AXP DWA PNRA AMGN X FB
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06:00 EDTAMGNAmgen price target raised to $150 from $143 at Piper Jaffray
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July 29, 2014
18:35 EDTAMGNOn The Fly: After Hours Movers
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16:22 EDTAMGNAmgen says total product sales increased 8% in Q2
Total product sales increased 8% for the second quarter of 2014 versus the second quarter of 2013. The increase was mainly driven by ENBREL, Kyprolis, Prolia and XGEVA. Product sales in the second quarter of 2013 included a positive adjustment of $185M to previous estimates for managed Medicaid rebates based on claims experience.
16:21 EDTAMGNAmgen to reduce global workforce by 12%-15%
The company announced a restructuring plan today to invest in continuing innovation and the launch of its new pipeline molecules, while improving its cost structure. Initial efforts include streamlining the organization, reducing layers of management, increasing managerial spans of responsibility and beginning implementation of a revised geographic site plan. As a first step, the company will reduce staff by 2,400-2,900, beginning later this year and continuing through 2015, predominantly in the U.S. This represents approximately 12% to 15% of Amgen’s global workforce. The company will also close its facilities in the states of Washington and Colorado
16:19 EDTAMGNAmgen raises FY14 EPS view to $8.20-$8.40 from $7.90-$8.20, consensus $8.09
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16:16 EDTAMGNAmgen reports Q2 EPS $2.37, consensus $2.07
Reports Q2 revenue $5.18B, consensus $4.9B.
15:53 EDTAMGNNotable companies reporting after market close
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13:49 EDTAMGNEarnings Preview: Amgen counting on newer drugs to boost sales
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11:11 EDTAMGNAmgen technical comments before results
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July 25, 2014
09:19 EDTAMGNAmgen weekly volatility elevated into Q2 and outlook
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07:36 EDTAMGNEMA adopts positive opinion on new indication for Xgeva
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05:35 EDTAMGNBayer, Onyx reports NEXAVAR Phase 3 trial did not meet primary endpoint
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July 17, 2014
16:10 EDTAMGNAmgen announces positive Phase 3 results for AMG 416
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