cytokinetics inc (CYTK) Key Developments
Cytokinetics, Incorporated Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-15-2015 11:20 AM
Mar 25 15
Cytokinetics, Incorporated Presents at Needham & Company's 14th Annual Healthcare Conference, Apr-15-2015 11:20 AM. Venue: Westin Grand Central Hotel, New York, New York, United States. Speakers: Robert I. Blum, Chief Executive Officer, President, Director and Chief Executive of the Biopharmaceutical Concern.
Cytokinetics, Incorporated Announces Publication of Results from Phase II Trial of Tirasemtiv in Patients with Myasthenia Gravis
Mar 25 15
Cytokinetics, Incorporated announced the publication of a manuscript relating to its fast skeletal muscle troponin activator tirasemtiv in the journal Neurotherapeutics. This publication summarizes results from a Phase IIa “Evidence of Effect” or hypothesis-generating clinical trial which evaluated tirasemtiv in patients with generalized myasthenia gravis (MG). Tirasemtiv is the lead drug candidate from Cytokinetics' skeletal muscle contractility program and is being developed as a potential treatment for amyotrophic lateral sclerosis (ALS). The publication, titled “A Double-Blinded, Randomized, Placebo-Controlled Trial to Evaluate Efficacy, Safety, and Tolerability of Single Doses of Tirasemtiv in Patients with Acetylcholine Receptor-Binding Antibody-Positive Myasthenia Gravis,” appeared online in the March edition of the journal Neurotherapeutics. The primary objective of this early-stage clinical study was to evaluate the effects of single 250 mg and 500 mg doses of tirasemtiv versus placebo on measures of skeletal muscle function and fatigability in patients with generalized MG and persistent muscle weakness. The secondary objectives of the study were to evaluate and characterize the relationship, if any, between the doses and plasma concentrations of tirasemtiv and its pharmacodynamic effects, and to evaluate the safety and tolerability of tirasemtiv administered as single doses to patients with MG. The authors concluded that 6 hours after dosing, tirasemtiv produced dose-related improvements from baseline in the Quantitative MG (QMG) score (slope: -0.49 QMG point per 250 mg administered; p=0.02; lower scores indicate better function) and in percentage predicted forced vital capacity (slope: 2.2% increase per 250 mg administered; p=0.04). The QMG improved by >3 points in twice as many patients after 500 mg tirasemtiv than after placebo. Both doses of tirasemtiv were well tolerated; there were no premature terminations or serious adverse events. The results of this study suggest that tirasemtiv may improve muscle function in patients with MG and support further development of tirasemtiv in neuromuscular diseases.
Cytokinetics, Incorporated Announces Completion of Enrollment in COSMIC-HF
Mar 13 15
Cytokinetics, Incorporated announced the completion of Phase II Clinical Trial of Oral Omecamtiv Mecarbil in Patients with Heart Failure. COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, study with two parts, a dose escalation phase and an expansion phase. The dose escalation phase assessed the pharmacokinetics and tolerability of three oral modified-release formulations of omecamtiv mecarbil in patients with heart failure and left ventricular systolic dysfunction and was used to select one formulation for further evaluation. The dose of omecamtiv mecarbil was 25 mg twice daily in the first escalation cohort and 50 mg twice daily in the second escalation cohort. The dose escalation phase of COSMIC-HF completed in 2013 and informed progression to the expansion phase. The ongoing expansion phase of the trial has enrolled 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 depends on the plasma concentration of omecamtiv mecarbil following 2 weeks of dosing with 25 mg twice daily. The primary objective of the expansion phase of COSMIC-HF is to characterize the safety, tolerability, and pharmacokinetics of oral omecamtiv mecarbil during 20 weeks of treatment. Secondary objectives are to assess 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 (a biomarker associated with the severity of heart failure) during 20 weeks of treatment.
Cytokinetics, Incorporated Presents at 27th Annual ROTH Conference, Mar-09-2015 08:30 AM
Feb 13 15
Cytokinetics, Incorporated Presents at 27th Annual ROTH Conference, Mar-09-2015 08:30 AM. Venue: The Ritz Carlton, 1 Ritz Carlton Dr, Dana Point, CA 92629, United States. Speakers: Robert I. Blum, Chief Executive Officer, President, Director and Chief Executive of the Biopharmaceutical Concern.
Cytokinetics, Incorporated Reports Unaudited Consolidated Earnings Results for the Fourth Quarter and Year Ended December 31, 2014; Provides Revenue Guidance for the Year 2015; Expects to Initiate Phase III Clinical Development Program in the Second Quarter of 2015 and Phase II Trial of Ck-2127107 in Patients with SMA in the Second Half of 2015
Feb 12 15
Cytokinetics, Incorporated reported unaudited consolidated earnings results for the fourth quarter and year ended December 31, 2014. For the quarter, the company reported total revenues of USD 21,758,000 against USD 24,349,000 a year ago. Operating income was USD 8,421,000 against USD 6,432,000 a year ago. Net income was USD 8,443,000 against USD 6,531,000 a year ago. Diluted net income per share was USD 0.23 against USD 0.21 a year ago.
For the year, the company reported total revenues of USD 46,940,000 against USD 30,648,000 a year ago. Operating loss was USD 14,754,000 against USD 33,894,000 a year ago. Net loss was USD 14,646,000 against USD 33,717,000 a year ago. Basic and diluted net loss per share was USD 0.41 against USD 1.24 a year ago.
The company also announced its financial guidance for 2015. The company anticipates cash revenue will be in the range of USD 40 to USD 43 million. This guidance includes approximately USD 30 million in revenue which will be deferred and recognized over a two year period ending in 2016 under generally accepted accounting principles. This guidance excludes the USD 15 million milestone payment earned in 2014 from Astellas and an estimated USD 3.6 million in non-cash related operating expenses primarily related to stock compensation expense.
The company expects to initiate a Phase III clinical development program for tirasemtiv in patients with ALS in the second quarter of 2015.
The company expects to initiate a Phase II trial of CK-2127107 in patients with SMA in the second half of 2015. The company expects enrollment of patients in the expansion phase of COSMIC-HF to conclude in the first quarter of 2015 and results from COSMIC-HF to be available in the second half of 2015. The company also expects to continue joint development activities in collaboration with Amgen directed to the potential advancement of omecamtiv mecarbil to Phase III clinical development.