Cytokinetics (CYTK) came out with a quarterly loss of $1.36 per share versus the Zacks Consensus Estimate of a loss of $1.27. This compares to loss of $1.35 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -7.09%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.02 per share when it actually produced a loss of $1.31, delivering a surprise of -28.43%.Over the last four quarters, the comp ...

Rolling Submission of NDA for Aficamten Completed and Submitted to FDA in Q3 COMET-HF, Confirmatory Phase 3 Clinical Trial of Omecamtiv Mecarbil,and AMBER-HFpEF, Phase 2 Clinical Trial of CK-586, Expected to Begin in Q4 Plan to Advance CK-089, Fast Skeletal Muscle Troponin Activator, into First-In-Human Study in Q4 2024 ~$1.3 Billion in Cash, Cash Equivalents and Investments as of September 30, 2024 SOUTH SAN FRANCISCO, Calif., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) repo ...

SOUTH SAN FRANCISCO, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that it is scheduled to report third quarter results on November 6, 2024 at 4:00 PM Eastern Time. Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future. The conference call will be simultaneously webcast and can be accessed from the Investors & Me ...

Core Insights - Cytokinetics has submitted a New Drug Application (NDA) for aficamten to the FDA and is preparing for a potential commercial launch in 2025 [2][8] - The company is advancing its cardiac myosin modulation programs, including the COMET-HF Phase 3 trial for omecamtiv mecarbil and the AMBER-HFpEF Phase 2 trial for CK-586, both expected to begin in Q4 2024 [1][5][6] Company Developments - The NDA submission for aficamten marks a significant step in the company's strategy to build a specialty cardiovascular franchise [2] - Cytokinetics is focusing on differentiated market access and patient experience as part of its go-to-market strategies for aficamten [8] - The company has launched an unbranded disease awareness campaign titled "HCM Beyond The Heart" aimed at healthcare professionals [1][8] Clinical Trials - COMET-HF is a Phase 3 trial designed to assess the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure and severely reduced ejection fraction, with an expected enrollment of approximately 1,800 patients [3][5] - AMBER-HFpEF is a Phase 2 trial aimed at evaluating the safety and tolerability of CK-586 in patients with symptomatic heart failure with preserved ejection fraction, also set to begin in Q4 2024 [6][18] Expert Perspectives - The event will feature insights from leading clinicians specializing in hypertrophic cardiomyopathy (HCM) and heart failure, enhancing the understanding of treatment landscapes [7] Global Launch Preparations - Cytokinetics is actively engaging with payers and conducting health economics research to support the launch of aficamten in the U.S. and Europe [8][10] - The company plans to submit a Marketing Authorization Application (MAA) for aficamten to the European Medicines Agency (EMA) in Q4 2024 [10]

Core Points - Cytokinetics has announced the seventh annual Communications Grant Program, offering five grants of $20,000 each to patient advocacy organizations focused on hypertrophic cardiomyopathy (HCM) and heart failure [1][2] - The program aims to enhance communications, awareness, and community engagement for underfunded nonprofit patient organizations [2] - Eligible organizations must be nonprofit or registered charities in the U.S., Canada, Europe, or the U.K., and serve HCM or heart failure communities [3] Grant Program Details - The deadline for applications is November 4, 2024, with recipients announced in January 2025 [1][3] - The grants can support various initiatives, including programming or personnel, to help organizations implement crucial communications and outreach activities [2][3] - Previous grant recipients include ALS Therapy Development Institute, Cardiomyopathy UK, Global Heart Hub, HeartBrothers Foundation, and WomenHeart [2] Company Overview - Cytokinetics is a late-stage biopharmaceutical company specializing in cardiovascular treatments, focusing on muscle biology and cardiac muscle performance [4] - The company is preparing for regulatory submissions for aficamten, a cardiac myosin inhibitor, following positive Phase 3 trial results [4] - Cytokinetics is also developing other drug candidates, including omecamtiv mecarbil for heart failure and CK-586 for HFpEF [4]

Analyses of Effects of Aficamten on Key Clinical Outcomes from SEQUOIA-HCM to be Featured in Late Breaking Clinical Trial Presentation at HFSA SOUTH SAN FRANCISCO, Calif., Sept. 19, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three upcoming presentations at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions on September 27, 2024 and one Late Breaking Clinical Trial presentation at the Heart Failure Society of America (HFSA) Annual Scientific Mee ...

Monday, Cytokinetics, Incorporated CYTK announced that data from the Phase 1 study of CK-4021586 (CK586) were presented in a poster session at the American College of Clinical Pharmacology Annual Meeting in Bethesda, MD. The study met its primary and secondary objectives to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple oral doses of CK-586. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of patients with symptomatic HFpEF wi ...

Phase 2 Clinical Trial in Patients with Heart Failure with Preserved Ejection Fraction Expected to Begin in Q4 2024 SOUTH SAN FRANCISCO, Calif., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that data from the Phase 1 study of CK-4021586 (CK-586) were presented in a poster session at the American College of Clinical Pharmacology (ACCP) Annual Meeting in Bethesda, MD. The study met its primary and secondary objectives to assess the safety, tolerability and pharm ...

Data from Integrated Safety Analysis Across Three Clinical Trials Reinforces Robust Safety Profile of Aficamten Analysis from FOREST-HCM Demonstrates Successful Withdrawal of Standard of Care Medications in Patients with Obstructive HCM Treated with Aficamten Company to Host Conference Call and Webcast Tuesday, September 3rd at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., Sept. 01, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that new data related to the safety and ...

Core Insights - Cytokinetics announced favorable results from the SEQUOIA-HCM trial, demonstrating that aficamten significantly improves cardiac remodeling, structure, function, and patient symptoms in individuals with symptomatic obstructive hypertrophic cardiomyopathy (HCM) [1][2][3] Clinical Trial Results - The SEQUOIA-HCM trial presented data showing that aficamten treatment led to a significant reduction in left ventricular mass index (LVMI) by -15.4 g/m² (p=0.001) and improvements in left ventricular maximal wall thickness, left atrial volume index, and extracellular volume mass index [3][4] - Aficamten improved echocardiographic measures, including a 60% reduction in left ventricular outflow tract gradient (LVOT-G) and no adverse changes in left ventricular ejection fraction (LVEF) [5][6] - The treatment resulted in significant improvements in patient-reported outcomes, with a 7.9-point increase in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) and a 7.8-point increase in the Seattle Angina Questionnaire Summary Score (SAQ-SS) [7][8] Biomarker Improvements - Aficamten treatment led to an 80% reduction in NT-proBNP and a 43% reduction in high-sensitivity cardiac troponin (hs-cTnI), both significant indicators of cardiac stress and injury [9][10] - Improvements in NT-proBNP were associated with enhanced exercise capacity and symptom relief, indicating its potential as a monitoring tool for treatment response [9][10] Future Developments - Cytokinetics plans to submit a New Drug Application (NDA) for aficamten to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in Q4 2024 [12][15] - The company is also conducting additional studies, including the MAPLE-HCM trial and the ACACIA-HCM trial, to further evaluate aficamten's efficacy in different patient populations [13][15]