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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.
News For CYTK;AMGN From The Last 14 Days
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June 30, 2015
11:36 EDTAMGNRumor: Amgen moves up on speculation of an investor stake
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07:03 EDTAMGNCelgene leaps forward in immuno-oncology with Juno deal, says Piper Jaffray
Piper Jaffray analyst Joshua Schimmer said that Celgene (CELG) effectively spent $1B to buy into adoptive T cell therapy and own all of Juno Therapeutics' (JUNO) opportunities outside the U.S., leaping the company into a leading position in the immuno-oncology space. Schimmer additionally thinks Celgene's transaction should help boost investor confidence about the utility and value of CAR and TCR therapies, noting that he sees Bellicum Pharmaceuticals (BLCM), Cellectis (CLLS), Lion Biotechnologies (LBIO), bluebird bio (BLUE) and the Amgen (AMGN)-Kite Pharma (KITE) partnership as best positioned to compete in this rapidly advancing field. The analyst keeps an Overweight rating and $144 price target on Celgene.
June 24, 2015
07:56 EDTAMGNAmgen management to meet with Evercore ISI
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June 23, 2015
07:25 EDTAMGNPiper Jaffray to hold a summit
2015 Piper Jaffray Heartland Summit is being held in Minneapolis on June 23-24.

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