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March 28, 2014
07:39 EDTAMGN, CYTKCytokinetics 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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July 28, 2015
07:34 EDTAMGNJefferies sees entry point for Aegerion, upgrades to Buy
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July 24, 2015
15:00 EDTAMGNBroader label for PCSK9 drug positive for Regeneron, Amgen, says Deutsche Bank
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12:44 EDTAMGNAmgen announces FDA approval of expanded Kyprolis indication
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12:27 EDTAMGNFDA approves expanded use of Kyprolis in multiple myeloma patients
The FDA announced that on July 24 the administration approved carfilzomib, or Kyprolis, marketed by Onyx Pharmaceuticals, an Amgen (AMGN) subsidiary, in combination with lenalidomide and dexamethasone for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. The revised labeling includes new Warnings and Precautions for VTE, cardiac toxicities, acute renal failure, pulmonary toxicities, and hypertension. The increased safety risks, including mortality, for elderly patients is described. Detailed safety information in the prescribing information was also updated for use of carfilzomib monotherapy. Reference Link
July 23, 2015
09:10 EDTAMGNAmgen submits NDA for Kyprolis in relapsed multiple myeloma
Amgen submitted a supplemental New Drug Application to the FDA for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial in which relapsed multiple myeloma patients treated with Kyprolis and dexamethasone lived twice as long without their disease worsening, demonstrating statistically and clinically significant superiority over Velcade.
July 21, 2015
12:47 EDTAMGNPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
11:49 EDTAMGNNovartis may sell Amgen's cancer drug as soon as September, Bloomberg says
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07:12 EDTAMGNAmgen's Repatha granted marketing authorization by EC
Amgen announced that the European Commission, or EC, has granted marketing authorization for Repatha, or evolocumab, the first proprotein convertase subtilisin/kexin type 9, or PCSK9, inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood.
July 16, 2015
16:05 EDTAMGNAmgen announces Phase 2 trial results evaluating Blincyto
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July 15, 2015
10:01 EDTCYTKOn The Fly: Analyst Initiation Summary
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08:59 EDTCYTKCytokinetics initiated with an Outperform at Cowen
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July 14, 2015
10:41 EDTCYTKCytokinetics awarded $1.5M grant for Phase 3 clinical trial, collaboration
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07:38 EDTCYTKCytokinetics awarded $1.5M grant by ALS Association
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07:37 EDTCYTKCytokinetics initiates Phase 3 clinical trial of tirasemtiv in ALS patients
Cytokinetics announced the start of VITALITY-ALS, or Ventilatory Investigation of Tirasemtiv and Assessment of Longitudinal Indices after Treatment for a Year in ALS, a Phase 3 clinical trial designed to assess the effects of tirasemtiv versus placebo on slow vital capacity, or SVC, and other measures of respiratory function in patients with ALS. VITALITY-ALS is a multi-national, randomized, double-blind, placebo-controlled trial that is designed to enroll 445 patients with possible, probable or definite ALS, diagnosed within 24 months, and with percent predicted SVC at baseline greater than or equal to 70%. Patients may be enrolled whether or not they are on riluzole therapy. The primary endpoint of the trial will assess change from baseline in SVC, to be assessed after 24 weeks of double-blind, placebo-controlled treatment. Secondary endpoints, to be assessed at 48 weeks, include time to decline in any of the three respiratory domains of the ALSFRS-R or death; time to decline from baseline in percent predicted SVC by greater than or equal to 20 percentage points or the onset of respiratory insufficiency or death; time to first occurrence of any use of assisted ventilation or death; time to decline from baseline in percent predicted SVC to less than or equal to 50% predicted or the onset of respiratory insufficiency or death; and change in the Mega-Score of muscle strength.

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