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cytokinetics inc (CYTK) Snapshot

Open
$4.25
Previous Close
$4.25
Day High
$4.32
Day Low
$4.16
52 Week High
07/26/13 - $13.30
52 Week Low
05/9/14 - $3.96
Market Cap
155.2M
Average Volume 10 Days
489.2K
EPS TTM
$-1.07
Shares Outstanding
36.6M
EX-Date
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Current Stock Chart for CYTOKINETICS INC (CYTK)

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cytokinetics inc (CYTK) Details

Cytokinetics, Incorporated, a clinical stage biopharmaceutical company, focuses on the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Its lead drug candidate from its cardiac muscle contractility program, omecamtiv mecarbil, is in Phase II clinical development for the treatment of heart failure. The company holds a license to develop and commercialize omecamtiv mecarbil and related compounds worldwide. It develops tirasemtiv, a fast skeletal muscle activator, as a potential treatment for diseases and medical conditions associated with neuromuscular dysfunction. Tirasemtiv is in Phase II clinical trials program and has been granted orphan drug designation and fast track status by the United States Food and Drug Administration and orphan medicinal product designation by the European Medicines Agency for the potential treatment of amyotrophic lateral sclerosis. Cytokinetics, Incorporated has a strategic alliance with Amgen Inc. to discover, develop, and commercialize small molecule therapeutics that activate cardiac muscle contractility for applications in the treatment of heart failure; and Astellas Pharma Inc. to develop a skeletal muscle activator structurally distinct from tirasemtiv, for non-neuromuscular indications. Cytokinetics, Incorporated was founded in 1997 and is headquartered in South San Francisco, California.

85 Employees
Last Reported Date: 03/7/14
Founded in 1997

cytokinetics inc (CYTK) Top Compensated Officers

Chief Executive Officer, President, Director ...
Total Annual Compensation: $555.0K
Chief Financial Officer, Principal Accounting...
Total Annual Compensation: $391.0K
Chief Medical Officer and Senior Vice Preside...
Total Annual Compensation: $388.0K
Senior Vice President of Research & Early Dev...
Total Annual Compensation: $347.5K
Senior Vice President of Human Resources
Total Annual Compensation: $278.0K
Compensation as of Fiscal Year 2013.

cytokinetics inc (CYTK) Key Developments

Cytokinetics, Incorporated Announces Additional Results from BENEFIT-ALS

Cytokinetics, Incorporated announced that additional results from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) were presented during a poster presentation at the 13th International Congress on Neuromus cular Diseases in Nice, France. The results from pre-specified subgroup analyses of BENEFIT-ALS were presented by Andrew A. Wolff, M.D., F.A.C.C., Senior Vice President, Clinical Research and Development, and Chief Medical Officer of Cytokinetics. These results indicate that the reduced decline in Slow Vital Capacity on tirasemtiv versus placebo in BENEFIT-ALS were observed consistently across all subgroups of patients with amyotrophic lateral sclerosis (ALS). The effects of tirasemtiv versus placebo on the changes from baseline to the average score after 8 and 12 weeks of treatment for the primary and secondary endpoints were evaluated in pre-specified analyses of subgroups based on age, sex, geography, riluzole use, onset of disease, weight, body-mass index (BMI) and baseline respiratory function. Based on these results, the authors concluded that tirasemtiv reduced the decline in SVC versus placebo by a similar magnitude regardless of age (=65 versus <65), sex, geographic region (Europe versus North America), riluzole use, site of ALS onset (bulbar versus limb), baseline pulmonary function, baseline weight, and baseline BMI. The reduced decline in SVC versus placebo was statistically significant within each subgroup examined except patients enrolled in Europe, those with bulbar onset, and those with a percent predicted SVC less the median at baseline. The authors concluded that tirasemtiv may have both immediate and longer term pharmacologic effects, especially on SVC, and that the potentially beneficial effects of tirasemtiv on measures of respiratory function and other assessments of skeletal muscle performance observed in BENEFIT-ALS merit further investigation. In addition, analyses presented indicated that tirasemtiv had no effect on Maximum Voluntary Ventilation (MVV) in any subgroup examined; however, a trend toward an increase in MVV on tirasemtiv versus placebo in patients with bulbar onset approached statistical significance. Overall, Sniff Nasal Inspiratory Pressure (SNIP) was reduced on tirasemtiv versus placebo and the magnitude of this effect was similar across all subgroups except in patients older than 65 years, in whom a marginal increase was observed. Conversely, the only subgroup in which the reduction of SNIP on tirasemtiv versus placebo was statistically significant was in patients less than 65 years old. In these subgroup analyses, tirasemtiv had no effect on the changes in muscle strength and in handgrip fatigue from baseline to the average after 8 and 12 weeks, neither overall nor within any of the subgroups.

Cytokinetics Announces Additional Data from BENEFIT-ALS to be Presented at the 13th International Congress on Neuromuscular Diseases

Cytokinetics, Incorporated announced that additional data from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) will be presented during a poster presentation scheduled at the 13th International Congress on Neuromuscular Diseases to be held July 5-10, 2014 at the Acropolis Convention Centre in Nice, France. The poster will include the first public presentation of the effects of tirasemtiv across patient subgroups on pre-specified secondary endpoints.

Cytokinetics, Incorporated Announces Additional Results from BENEFIT-ALS

Cytokinetics, Incorporated announced that additional results from BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS) were presented during the Joint Congress of European Neurology at the International Congress Center in Istanbul, Turkey. The new data from BENEFIT-ALS were presented by Jeremy M. Shefner, M.D., Ph.D., Professor and Chair, Department of Neurology at the Upstate Medical University, State University of New York and the Lead Investigator for BENEFIT-ALS. In BENEFIT-ALS, patients with amyotrophic lateral sclerosis (ALS) were randomized 1:1 to double-blind treatment with tirasemtiv or placebo for 12 weeks. The primary outcome measure, the ALS Functional Rating Scale in its revised form (ALSFRS-R), and secondary outcomes measures of respiratory performance and other measures of skeletal muscle function and fatigability were assessed after 4, 8, and 12 weeks of double-blind treatment, and again at 1 and 4 weeks after the last dose of double-blind treatment. The results from double-blind treatment during BENEFIT-ALS were presented at the Annual Meeting of the American Academy of Neurology. Differences detected during double-blind treatment in the percentage changes from baseline in Muscle Strength Mega-Score between tirasemtiv and placebo were not sustained during the follow-up period. No differences in Maximum Voluntary Ventilation and Hand Grip Fatigue were observed on tirasemtiv versus placebo during double-blind treatment nor during the period through 4 weeks after the last double-blind dose. These data suggest that tirasemtiv may have effects on the respiratory muscles involved in performing the Slow Vital Capacity assessment that extend beyond its immediate pharmacologic action, stated Andrew A. Wolff, M.D., F.A.C.C., Cytokinetics' Chief Medical Officer and Senior Vice President of Clinical Research and Development. The absence of a difference between tirasemtiv and placebo on muscle strength and other endpoints at 4 weeks after double-blind treatment is consistent with diminishing pharmacologic effects of tirasemtiv following its discontinuation. They are encouraged by these results and are continuing its analyses of data from BENEFIT-ALS to inform the potential further development of tirasemtiv in patients with ALS. Tirasemtiv is the lead drug candidate from Cytokinetics' skeletal muscle contractility program. Tirasemtiv selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium and, in preclinical studies and early clinical trials, demonstrated increases in skeletal muscle force in response to neuronal input and delays in the onset and reductions in the degree of muscle fatigue. BENEFIT-ALS was a Phase IIb, multi-national, double-blind, randomized, placebo-controlled, clinical trial designed to evaluate the safety, tolerability and efficacy of tirasemtiv in patients with amyotrophic lateral sclerosis (ALS). BENEFIT-ALS enrolled 711 patients in 73 centers in 8 countries. Patients enrolled in BENEFIT-ALS began treatment with open-label tirasemtiv at 125 mg twice daily. 605 patients were randomized 1:1 to receive 12 weeks of double-blind treatment with twice-daily oral ascending doses of tirasemtiv or placebo (302 to placebo; 303 to tirasemtiv), beginning at 125 mg twice daily and increasing weekly up to 250 mg twice daily (or a dummy dose titration with placebo). Clinical assessments occurred every four weeks during double-blind treatment; patients also returned for follow-up evaluations at one and four weeks after their final dose of double-blind study medication. The primary efficacy analysis of BENEFIT-ALS compared the mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) to the average of the scores obtained after 8 and 12 weeks of double-blind treatment on tirasemtiv versus placebo. Secondary endpoints evaluated measures of respiratory performance and other measures of skeletal muscle function and fatigability were assessed after 4, 8, and 12 weeks of double-blind treatment (n = 210, 204, and 199 for placebo and 174, 151 and 144 for tirasemtiv, respectively), and again at 1 and 4 weeks after the last dose of double-blind treatment (n = 191 and 188 for placebo and 156 and 164 for tirasemtiv, respectively). BENEFIT-ALS did not achieve its primary efficacy endpoint (ALSFRS-R) on tirasemtiv versus placebo (-2.98 points in the tirasemtiv group versus -2.40 points in the placebo group, p = 0.11). However, treatment with tirasemtiv in BENEFIT-ALS resulted in a statistically significant and potentially clinically meaningful reduction in the decline of Percent Predicted Slow Vital Capacity (SVC, a measure of the strength of the skeletal muscles responsible for breathing) that has been shown to be an important predictor of disease progression and survival in prior trials of patients with ALS. After 12 weeks of double-blind treatment, SVC declined by 8.66 percentage points on placebo compared to 3.12% points on tirasemtiv (p < 0.0001). The Muscle Strength Mega-Score, a measure of strength combining the data from several muscle groups in each patient, declined more slowly on tirasemtiv versus placebo (p = 0.016 for the difference in slope of decline); however, there were no differences at any time point that reached statistical significance. The rate of decline for Sniff Nasal Inspiratory Pressure (SNIP) was not statistically significant different (p = 0.21); however, SNIP decreased more on tirasemtiv compared with placebo in a statistically significant manner at 4 and 12 weeks (p values at 4, 8, and 12 weeks were 0.012, 0.066, 0.050, respectively). No differences in Maximum Voluntary Ventilation and Hand Grip Fatigue were observed on tirasemtiv versus placebo. Amyotrophic lateral sclerosis is a progressive neurodegenerative disease that afflicts approximately 25,000 people in the United States and a comparable number of patients in Europe. Approximately 5,600 new cases of ALS are diagnosed each year in the United States. The average life expectancy of an ALS patient is approximately three to five years after diagnosis and only 10% of patients survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapeutic options to address the symptoms and modify the disease progression of this grievous illness.

 

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