# Cytokinetics Announces Positive Topline Results from ACACIA-HCM, the Pivotal Phase 3 Clinical Trial of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy Canonical URL: https://biopharmsignal.com/news/CYTK/cytokinetics-announces-positive-topline-results-from-acacia-hcm-the-pivotal-phas-7e221cd2 Ticker: CYTK Company: Cytokinetics Source: Cytokinetics Published: 2026-05-05 11:30 EST ## Summary Trial Met Dual Primary Endpoints of KCCQ and Maximal Exercise Performance With Consistent Positive Findings Across Key Secondary Endpoints Company to Host... ## Article Body Trial Met Dual Primary Endpoints of KCCQ and Maximal Exercise Performance With Consistent Positive Findings Across Key Secondary Endpoints Company to Host Conference Call and Webcast Tuesday May 5 at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., May 05, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced positive topline results from ACACIA-HCM ( A ssessment C omparing A ficamten to Placebo on C ardiac Endpoints I n A dults with N on-Obstructive HCM ), the pivotal Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (HCM). ACACIA-HCM met both dual primary endpoints, demonstrating statistically significant improvements from baseline to Week 36 compared to placebo in both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO 2 ) (Table 1). “Patients with non-obstructive HCM have no therapies approved to treat the underlying hypercontractility associated with the disease. We hope that will change with ACACIA-HCM which is the first clinical trial to demonstrate statistically significant improvements in exercise capacity and symptom burden in patients with non-obstructive HCM,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “We believe that the totality and consistency of evidence favoring aficamten across multiple patient-reported and physician-assessed endpoints of symptom improvement and physical function are clinically meaningful for patients with non-obstructive HCM.” Table 1: Primary Endpoint Results | Primary Endpoints | Change from Baseline to Week 36 LSM (95% CI) | Aficamten vs Placebo LSM (95% CI) | p-value | | | --- | --- | --- | --- | --- | | | Aficamten | Placebo | | | | KCCQ-CSS | 11.4 (9.6 – 13.2) | 8.4 (6.6 – 10.2) | 3.0 (0.5 - 5.5) | 0.021 | | pVO 2 (mL/kg/min) | 0.64 (0.32 – 0.95) | -0.03 (-0.35 – 0.28) | 0.67 (0.22 - 1.1) | 0.003 | | LSM = least square mean; CI = confidence interval | | | | | The improvement in KCCQ was robust and consistent throughout the treatment period in participants on aficamten. Following washout, KCCQ decreased for participants on aficamten to match the placebo group. At Week 36, pVO 2 increased for participants on aficamten , while it remained unchanged for participants on placebo, consistent with prior trials of aficamten in obstructive HCM (oHCM) (Figure 1). Figure 1: Assessments of KCCQ and pVO 2 Statistically significant (p5% of patients and more commonly on MYQORZO than on placebo in the pivotal trial. INDICATIONS AND USAGE MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. Please see full Prescribing Information , including Boxed WARNING. About Hypertrophic Cardiomyopathy Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. HCM can be obstructive, when thickened muscle blocks blood flow, or non-obstructive, when blood flow is not blocked but heart function is still affected. In obstructive HCM, the thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller, stiffer and less able to relax and fill with blood. Ultimately, HCM limits the heart’s pumping function, leading to reduced exercise capacity and a variety of symptoms. HCM is the most common monogenic inherited cardiovascular disorder, with well over 300,000 patients diagnosed in the U.S. However, there are an estimated 400,000-800,000 additional patients who remain undiagnosed. 2 , 3 , 4 Recent analysis of a large claims database indicates that approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM). 5 People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease. 6 People with HCM are at risk for potentially fatal ventricular arrhythmias and it is one of the leading causes of sudden cardiac death in younger people or athletes. 7 A subset of patients with HCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation. There are no currently approved therapies for nHCM. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO ® ( aficamten ) is a cardiac myosin inhibitor approved in the U.S., European Union and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Cytokinetics is also developing omecamtiv mecarbil , an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten , an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X , LinkedIn , Facebook and YouTube . Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the enrollment, expected results or timing of completion of any of our clinical trials, the clinical meaningfulness, persuasiveness or interpretation of clinical trial results, including for purposes of regulatory approval, labeling, or market acceptance, the results of long-term, secondary or exploratory analyses, including analyses of time to first cardiovascular event, statements relating to our ability to obtain regulatory approval for aficamten in nonobstructive hypertrophic cardiomyopathy in any jurisdiction by any particular date, if ever, the number of patients comprising the eligible treatment population for aficamten , or market acceptance of aficamten for the treatment of nonobstructive hypertrophic cardiomyopathy. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing of Cytokinetics’ drug candidates that could slow or prevent clinical development or product approval; Cytokinetics’ drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics’ drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics’ drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics’ business, investors should consult Cytokinetics’ filings with the Securities and Exchange Commission including the risk factors included in Cytokinetics’ most recent Annual Report on Form 10-K and subsequent reports filed with the SEC. CYTOKINETICS ® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO ® is a registered trademark of Cytokinetics in the U.S. and the European Union. References Hartman JJ, Hwee DT, Robert-Paganin J, et al. Aficamten is a small-molecule cardiac myosin inhibitor designed to treat hypertrophic cardiomyopathy. Nat Cardiovasc Res. 2024;3(8) :1003-1016. doi:10.1038/s44161-024-00505-0 CVrg: Heart Failure 2020-2029, p 44; Maron et al. 2013 doi:10.1016/S0140-6736(12)60397-3; Maron et al 2018 10.1056/NEJMra1710575 Symphony Health 2016-2021 Patient Claims Data DoF; Maron MS, Hellawell JL, Lucove JC, Farzaneh-Far R, Olivotto I. Occurrence of Clinically Diagnosed Hypertrophic Cardiomyopathy in the United States. Am J Cardiol. 2016; 15;117(10):1651-1654. Butzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552 Gersh, B.J., Maron, B.J., Bonow, R.O., Dearani, J.A., Fifer, M.A., Link, M.S., et al. 2011 ACCF/AHA guidelines for the diagnosis and treatment of hypertrophic cardiomyopathy. A report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Journal of the American College of Cardiology and Circulation, 58, e212-260. Hong Y, Su WW, Li X. Risk factors of sudden cardiac death in hypertrophic cardiomyopathy. Current Opinion in Cardiology. 2022 Jan 1;37(1):15-21 Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Affairs (415) 290-7757 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/adcf634e-a2a7-4cdf-98b3-ca658eab1b35 ## Recent Company News - 2026-07-23 20:00 EST — [Cytokinetics to Announce Second Quarter Results on August 6, 2026](https://biopharmsignal.com/news/CYTK/cytokinetics-to-announce-second-quarter-results-on-august-6-2026-18350192) — Source: Cytokinetics - 2026-07-17 20:00 EST — [Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)](https://biopharmsignal.com/news/CYTK/cytokinetics-announces-inducement-grants-under-nasdaq-listing-rule-5635-c-4-1e80a7fe) — Source: Cytokinetics - 2026-07-07 11:30 EST — [Cytokinetics Announces Three Late-Breaking Science Abstracts at the European Society of Cardiology (ESC) Congress 2026](https://biopharmsignal.com/news/CYTK/cytokinetics-announces-three-late-breaking-science-abstracts-at-the-european-soc-852ccfe1) — Source: Cytokinetics - 2026-06-17 20:00 EST — [Cytokinetics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)](https://biopharmsignal.com/news/CYTK/cytokinetics-announces-inducement-grants-under-nasdaq-listing-rule-5635-c-4-12014bdd) — Source: Cytokinetics - 2026-06-08 11:30 EST — [Cytokinetics Announces Call for Proposals for Annual Corporate Giving Program](https://biopharmsignal.com/news/CYTK/cytokinetics-announces-call-for-proposals-for-annual-corporate-giving-program-d243df03) — Source: Cytokinetics ## Related News - 2026-07-29 14:05 EST — CAPR — [The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy](https://biopharmsignal.com/news/CAPR/the-lancet-publishes-hope-3-data-for-capricor-therapeutics-deramiocel-in-duchenn-9e6e6bd9) - 2026-07-29 13:00 EST — ENLV — [Enlivex Management to Host Webinar to Discuss Capital Strategy, Rain Protocol Treasury Strategy, and Recent Clinical Milestones](https://biopharmsignal.com/news/ENLV/enlivex-management-to-host-webinar-to-discuss-capital-strategy-rain-protocol-tre-5921a627) - 2026-07-29 12:30 EST — PRGO — [Perrigo to Present at the Canaccord 46th Annual Growth Conference](https://biopharmsignal.com/news/PRGO/perrigo-to-present-at-the-canaccord-46th-annual-growth-conference-40431922) - 2026-07-29 12:30 EST — LIXT — [NOMAD Announces Operational Deployment of Two Mobile Battery Systems by DSO Electric Cooperative](https://biopharmsignal.com/news/LIXT/nomad-announces-operational-deployment-of-two-mobile-battery-systems-by-dso-elec-7fc12a2c) - 2026-07-29 12:30 EST — RNXT — [RenovoRx to Host Second Quarter 2026 Financial Results and Business Highlights Conference Call on August 12th at 4:30 p.m. ET](https://biopharmsignal.com/news/RNXT/renovorx-to-host-second-quarter-2026-financial-results-and-business-highlights-c-8bed10ec)