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June 13, 2014
16:12 EDTCYTKCytokinetics says Tirasemtiv increases muscle force, improves grip strength
Cytokinetics announced that data from preclinical research relating to Tirasemtiv in mouse models of spinal muscular atrophy were presented at the 2014 Annual Spinal Muscular Atrophy Conference in National Harbor, Maryland. In these models, Tirasemtiv increased muscle force and improved grip strength, grid hang time, and resistance to fatigue.
News For CYTK From The Last 14 Days
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October 30, 2014
16:10 EDTCYTKCytokinetics sees FY14 cash revenues $19M-$21M
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16:09 EDTCYTKCytokinetics reports Q3 EPS (16c), consensus (24c)
Reports Q3 revenue $9.4M, consensus $7.38M.
October 27, 2014
07:39 EDTCYTKCytokinetics provides development program update for omecamtiv mecarbil
Cytokinetics provided an update relating to omecamtiv mecarbil, the company's lead drug candidate from its cardiac muscle contractility program. The company announced that COSMIC-HF, or Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure, has enrolled over 275 patients towards the objective of 450 patients in the ongoing expansion phase of the trial. In addition, over 70 patients have completed the 20 weeks of dosing in the expansion phase of COSMIC-HF. Recently, the Data Monitoring Committee reviewed data from COSMIC-HF and recommended that the trial continue without any changes to the protocol. Patient enrollment in COSMIC-HF is expected to conclude by the end of 2014. The company also announced that CY 1211, a Phase I study comparing the tolerability and pharmacokinetics of omecamtiv mecarbil between Japanese and Caucasian healthy volunteers, is complete and indicates no clinically meaningful differences between the two groups studied. Data from CY 1211 are expected to inform plans for the development of omecamtiv mecarbil in Japan and the inclusion of Japan in potential global Phase III program activities.
October 20, 2014
07:37 EDTCYTKCytokinetics completes review results from BENEFIT-ALS regarding tirasemtiv
Cytokinetics provided a program update today relating to tirasemtiv, the company's lead drug candidate from its skeletal muscle contractility program. The company announced that it has completed its review of results from BENEFIT-ALS and has concluded that effects observed on Slow Vital Capacity in patients treated with tirasemtiv are robust and potentially clinically meaningful. In addition, following consultation with clinical and statistical experts, the company believes that data from BENEFIT-ALS support progression of tirasemtiv to a potential Phase III clinical trial in patients with amyotrophic lateral sclerosis (ALS). The company also announced that it has begun regulatory interactions with the U.S. Food and Drug Administration regarding results from BENEFIT-ALS and has received initial feedback from the FDA. The company believes that effects on SVC could be a Phase III clinical trial endpoint and could support registration of tirasemtiv as a potential treatment for patients with ALS. As a result, Cytokinetics has initiated planning for a potential Phase III clinical trial of tirasemtiv that could begin in 2015. Cytokinetics has received feedback from the FDA following initial communications regarding tirasemtiv and BENEFIT-ALS. The company believes that the FDA may be willing to consider a potential registration path for tirasemtiv relating to effects on SVC. The company expects to have additional interactions with the FDA and other regulatory authorities. In addition, the company has commenced Phase III readiness activities including designing a potential Phase III clinical trial in order to inform plans, timelines and costs associated with the further development of tirasemtiv.

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