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Cytokinetics to Announce Fourth Quarter Results on February 24, 2026
Globenewswire· 2026-02-12 21:00
Core Insights - Cytokinetics is set to report its fourth quarter results on February 24, 2026, at 4:00 PM Eastern Time, followed by a conference call at 4:30 PM to discuss financial results and business updates [1][2] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [3] - The company’s MYQORZO™ (aficamten) is approved for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) and has received positive recommendations for marketing authorization in the European Union, with a decision expected in the first quarter of 2026 [3] - Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for heart failure with severely reduced ejection fraction, and ulacamten, an investigational cardiac myosin inhibitor for heart failure with preserved ejection fraction [3]
Cytokinetics Announces Recipients of Its Eighth Annual Communications Grant Program
Globenewswire· 2026-02-09 12:30
Core Insights - Cytokinetics has awarded grants to two patient advocacy organizations to enhance communication and community outreach for hypertrophic cardiomyopathy (HCM) [2][3] Group 1: Grant Recipients and Initiatives - Camp Taylor received a grant to produce "Living with HCM: Youth Voices from Camp Taylor," a digital initiative that includes a five-part video series and an information toolkit aimed at educating families about HCM [4] - The Canadian Sudden Arrhythmia Death Syndromes (SADS) Foundation will develop "Think. Know. Act.: Cardiomyopathy Awareness in Canada," a six-month digital campaign to raise awareness of HCM symptoms and management among Canadian families [5] Group 2: Purpose and Impact of the Grant Program - The Cytokinetics Communications Grant Program aims to support patient advocacy organizations by providing resources for communications and outreach initiatives that are otherwise difficult to implement [6] - The program has been active for eight years, focusing on increasing awareness and community engagement for patient communities [6] Group 3: Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology and a pipeline of potential new medicines for cardiac muscle dysfunction [7] - The company’s product MYQORZO™ (aficamten) is approved for treating adults with symptomatic obstructive HCM, with positive opinions for marketing authorization in the European Union expected in early 2026 [7][8]
Cytokinetics and Olympic Gold Medalist Sydney McLaughlin-Levrone Team Up to Raise Awareness of the Whole-Person Impact of Hypertrophic Cardiomyopathy (HCM)
Globenewswire· 2026-01-27 13:00
Core Insights - Cytokinetics has launched the "On Track with HCM" campaign to support the hypertrophic cardiomyopathy (HCM) community, featuring Sydney McLaughlin-Levrone and her father, Willie McLaughlin, who has lived with HCM for over two decades before receiving a heart transplant [1][2]. Company Commitment - The campaign is designed in collaboration with the HCM patient advocacy community to assist patients in managing the symptoms of HCM in their daily lives [2][4]. - Cytokinetics aims to address both clinical care and the human experience of living with HCM, empowering patients and their families to lead healthier lives [4]. HCM Overview - HCM is the most common inherited heart disease, affecting approximately 1 in every 350 people in the U.S., with many remaining undiagnosed [3][7]. - The disease can lead to serious complications such as atrial fibrillation, heart failure, and sudden cardiac arrest [3][6]. Educational Resources - The "On Track with HCM" program includes a website and eight original videos that share personal experiences and expert insights on managing HCM [2][4]. - The content covers various aspects of living with HCM, including fitness, nutrition, and the mind-body connection [5]. Cytokinetics' Product Pipeline - Cytokinetics is advancing its pipeline of potential new medicines for cardiac muscle dysfunction, including MYQORZO™ (aficamten), which is approved for treating symptomatic obstructive HCM [8]. - The company is also developing other investigational treatments for heart failure and continues research in muscle biology [8].
Cytokinetics Announces MYQORZO™ (aficamten) Now Available in the U.S. for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
Globenewswire· 2026-01-27 12:30
Core Insights - MYQORZO™ (aficamten) has been approved by the U.S. FDA for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aimed at improving functional capacity and symptoms [1][4][5] - The drug is available in multiple dosages (5 mg, 10 mg, 15 mg, and 20 mg) and is a once-daily oral allosteric and reversible inhibitor of cardiac myosin motor activity, which reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in patients with oHCM [2][17] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [21] - The launch of MYQORZO marks a significant milestone for Cytokinetics, reflecting its commitment to patients and the culmination of extensive scientific and clinical development efforts [3][21] Product Details - MYQORZO is indicated specifically for adults with symptomatic oHCM, and it works by inhibiting cardiac myosin to alleviate symptoms associated with the condition [5][17] - The drug has been engineered for predictable exposure response, rapid onset of action, and reversibility, making it a novel treatment option for patients [17] Clinical and Safety Information - The approval of MYQORZO was based on positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine [4] - Important safety information includes a boxed warning for the risk of heart failure due to reduced left ventricular ejection fraction (LVEF), necessitating regular echocardiogram assessments during treatment [6][9][10] Distribution and Support Programs - MYQORZO is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program, which includes specific requirements for prescribers, patients, and pharmacies [11][15] - Cytokinetics has established a personalized support program, MYQORZO & You™, to assist patients in navigating their treatment journey and provide education and financial assistance [4][21]
Cytokinetics to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-05 21:00
Core Insights - Cytokinetics, Incorporated will present at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, at 9:45 AM Pacific Time [1] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [3] - The company’s product MYQORZO™ (aficamten) is approved for treating adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) by the U.S. FDA and the China National Medical Products Administration [3] - The European Medicines Agency has adopted a positive opinion for MYQORZO™ (aficamten), with a decision from the European Commission expected in Q1 2026 [3] - Cytokinetics is also developing omecamtiv mecarbil for heart failure with severely reduced ejection fraction and ulacamten for heart failure with preserved ejection fraction, alongside ongoing pre-clinical research in muscle biology [3]
Cytokinetics Announces FDA Approval of MYQORZO™ (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms
Globenewswire· 2025-12-19 21:00
Core Insights - The U.S. FDA has approved MYQORZO™ (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), marking it as the company's first FDA-approved medicine [1][2][22] - MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity, designed to improve functional capacity and symptoms in patients with oHCM [1][22] - The approval is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, which demonstrated significant improvements in exercise capacity and symptom reduction [6][5] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company focused on developing new medicines for diseases of cardiac muscle dysfunction [27] - The company has over 25 years of experience in scientific innovations in muscle biology and is advancing a pipeline that includes MYQORZO and other investigational drugs [27] Product Details - MYQORZO is available in 5 mg, 10 mg, 15 mg, and 20 mg tablet forms and is expected to be available in the U.S. in the second half of January 2026 [1][3] - The drug is associated with a straightforward dosing regimen and does not require drug-drug interaction monitoring, contributing to its predictable safety profile [2] Clinical Trial Insights - In the SEQUOIA-HCM trial, MYQORZO improved peak oxygen uptake (pVO2) by 1.8 mL/kg/min compared to placebo, with a statistically significant p-value of 0.000002 [6] - The treatment was well-tolerated, with serious adverse events occurring in 5.6% of patients on MYQORZO compared to 9.3% on placebo [7] Safety Information - MYQORZO carries a Boxed WARNING for the risk of heart failure due to its effect on reducing left ventricular ejection fraction (LVEF) [10][22] - Echocardiogram assessments are required prior to and during treatment to monitor for systolic dysfunction, with specific dosing adjustments based on LVEF levels [11][15] Market Context - Hypertrophic cardiomyopathy (HCM) is the most common monogenic inherited cardiovascular disorder, with over 300,000 diagnosed patients in the U.S. and an estimated additional 400,000-800,000 undiagnosed [25][24] - Approximately half of HCM patients have obstructive HCM (oHCM), highlighting the need for effective treatment options like MYQORZO [25]