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Key Takeaways Cytokinetics' aficamten improved cardiac structure and diastolic function in non-obstructive HCM.Aficamten outperformed metoprolol across pre-trial treatment groups in patients with obstructive HCM.Cytokinetics plans an nHCM filing in Q4 2026, potentially expanding aficamten's addressable market. Cytokinetics, Incorporated (CYTK - Free Report) recently announced additional results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints in Adults with Non-Obstructive HCM) and MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) studies.

The results were presented in a Late Breaking Clinical Session at the European Society of Cardiology Congress 2026 in Munich, Germany.

Additional analyses of ACACIA-HCM and MAPLE-HCM elaborate on the primary results from each study and expand the evidence base supporting the potential use of aficamten across the spectrum of HCM.

We note that CYTK obtained FDA approval of aficamten under the brand name Myqorzo in December 2025 for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Strong initial uptake of the drug, along with Myqorzo’s expanding international presence, positions it as a meaningful commercial opportunity in the oHCM market.

CYTK is also looking to expand Myqorzo’s label.

More on CYTK’s ACACIA-HCM StudyACACIA-HCM was a phase III, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the effect of aficamten compared to placebo in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

Additional results from ACACIA-HCM demonstrate improvements in cardiac structure and diastolic function in patients with nHCM.

CYTK had earlier reported that ACACIA-HCM met both primary endpoints in symptomatic nHCM, showing statistically significant improvements in KCCQ Clinical Summary Score and maximal exercise performance (pVO2) versus placebo.

The additional ACACIA-HCM results suggest that aficamten’s benefits in nHCM may extend beyond improving exercise capacity and symptoms to reducing wall thickness and improving diastolic function. These findings provide further insight into how aficamten may benefit patients and highlight its potential as an important treatment option for nHCM, where no approved therapies currently exist.

Cytokinetics plans to submit a supplemental new drug application (sNDA) for aficamten in this indication in the fourth quarter of 2026. A potential approval in nHCM will expand the addressable market.

More on CYTK’s MAPLE-HCM Study     MAPLE-HCM was a phase III, multi-center, randomized, double-blind active-comparator clinical trial of aficamten compared to metoprolol in patients with symptomatic oHCM.

As previously reported, the primary results of MAPLE-HCM demonstrated superiority of aficamten to metoprolol on pVO2. This post-hoc analysis evaluated the effects of aficamten and metoprolol on the primary and key secondary endpoints based on pre-trial medical therapy.

The new analysis of MAPLE-HCM showed that aficamten outperformed metoprolol across pre-trial treatment groups in patients with oHCM.

The FDA had earlier accepted CYTK’s sNDA for MAPLE-HCM, a phase III study of aficamten as monotherapy compared with metoprolol as monotherapy in patients with oHCM. The regulatory body assigned a target action date of Nov. 14, 2026.

Competition for CYTK’s MyqorzoMyqorzo operates within an evolving treatment landscape for oHCM. Its primary branded competitor is Camzyos, a cardiac myosin inhibitor marketed by Bristol Myers Squibb (BMY - Free Report) . In addition to this direct competition, Myqorzo faces established generic therapies, namely beta blockers and calcium channel blockers, which continue to serve as the first-line standard of care.

BMY obtained FDA approval for Camzyos in 2022 for the treatment of adults with symptomatic New York Heart Association class II-III obstructive HCM to improve functional capacity and symptoms.

The drug continues to gain traction in the targeted market, supported by growing demand and increased adoption among eligible patients.

The FDA accepted BMY’s supplemental new drug application seeking approval of Camzyos for the treatment of adolescents aged 12 to under 18 years with symptomatic oHCM.

A potential competitor for Cytokinetics is Edgewise Therapeutics, Inc. (EWTX - Free Report) , which is advancing a cardiovascular pipeline targeting HCM, heart failure, and other cardiovascular and cardiometabolic conditions.

EWTX’s lead candidate, EDG-7500, is a novel, oral, selective cardiac sarcomere modulator currently being studied in a multipart phase II study in patients with oHCM and nHCM, with a phase III program targeted to be launched in the fourth quarter of 2026.

EWTX’s pipeline also includes EDG-15400 for heart failure. The company expects to initiate a phase II study on EDG-15400 in participants with heart failure with preserved ejection fraction in the second half of 2026.  

CYTK’s Price Movement, Valuation and EstimatesCytokinetics’ shares have gained 12.4% year to date compared with the industry’s 8.7% growth.

Image Source: Zacks Investment Research

Going by the price/sales ratio, CYTK’s shares currently trade at 26.6X forward sales, higher than the industry’s average of 1.94X but lower than its mean of 49.08X.

Image Source: Zacks Investment Research

The Zacks Consensus Estimate for 2026 loss per share has narrowed to $6 from $6.26 over the past 60 days and the same for 2027 loss has narrowed to $4.54 from $4.59 over the same period.

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Hot Line Presentation of Primary Results from ACACIA-HCM to Elaborate on Positive Topline Results in Patients with Non-Obstructive Hypertrophic Cardiomyopathy

Company to Host In-Person and Virtual Investor Event to Discuss Results from
Late-Breaking Science Presentations

SOUTH SAN FRANCISCO, Calif., Aug. 20, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced upcoming presentations, including a Hot Line presentation and two Late Breaking Science presentations, at the European Society of Cardiology (ESC) Congress, taking place August 28-31 in Munich, Germany.

Hot Line and Late-Breaking Science Presentations

Title: ACACIA-HCM: Aficamten for Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
Presenter: Ahmad Masri, M.D., M.S., Associate Professor of Medicine, Director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University
Date: Friday, August 28, 2026
Session Title: Hot Line 1
Session Time: 11:00 AM – 12:18 PM CEST
Presentation Time: 11:45 – 11:58 AM CEST
Location: Munich, Main Auditorium (Hall B3)

Title: Effect of Aficamten on Cardiac Structure and Function in Patients with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Results from the ACACIA-HCM Trial
Presenter: Sheila Hegde, M.D., MPH, Assistant Professor, University of Texas Southwestern Medical Center – Dallas, TX and Affiliate Faculty, Brigham and Women's Hospital, Boston, MA
Date: Saturday, August 29, 2026
Session Title: Late-Breaking Clinical Science: Hypertrophic Cardiomyopathy
Session Time: 4:15 – 5:15 PM CEST
Presentation Time: 4:15 – 4:30 PM CEST
Location: Ashgabat (Hall A3)

Title: Aficamten vs. Metoprolol Monotherapy in Obstructive Hypertrophic Cardiomyopathy According to Pre-Trial Treatment in MAPLE-HCM
Presenter: Fernando Dominguez, M.D., Ph.D., Consultant Cardiologist, Hospital Universitario Puerta De Hierro Majadahonda – Madrid, Spain
Date: Saturday, August 29, 2026
Session Title: Late-Breaking Clinical Science: Hypertrophic Cardiomyopathy
Session Time: 4:15 – 5:15 PM CEST
Presentation Time: 4:30 – 4:45 PM CEST
Location: Ashgabat (Hall A3)

Poster Presentations

Title: Impact of Peak Provoked Left Ventricular Outflow Tract Gradients on Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy: A Real-World Cross-Sectional Survey
Presenter: Paulos Gebrehiwet, Ph.D., M.S., Senior Manager, Health Economics and Outcomes Research Europe, Cytokinetics
Session Date: Saturday, August 29, 2026
Session Title: Improving Diagnosis and Treatment in Hypertrophic Cardiomyopathy
Session Time: 8:15 AM – 9:00 AM CEST
Location: Station 12 (Research Gateway – Hall A1)

Title: Real-World Clinical Burden of Obstructive Hypertrophic Cardiomyopathy: A Nationwide Study in France
Presenter: Prof. Albert Hagege, M.D., Ph.D., Director, Cardiovascular Department, European Hospital Georges Pompidou, Paris, France
Session Title: Hypertrophic Cardiomyopathy: Disease Burden, Risk Stratification, and Clinical Outcomes
Session Date: Sunday, August 30, 2026
Session Time: 12:15 PM – 1:00 PM CEST
Location: Exchange Circle 3 (Research Gateway – Hall A1)

Investor Event and Webcast

Cytokinetics will host an in-person investor event in Munich, Germany on August 28, 2026 at 2:00 PM Central European Summer Time (8:00 AM Eastern Time). The event will also be simultaneously webcast live online. Interested parties must register to attend in-person or online at https://acacia-hcm-investor-event-esc-2026.open-exchange.net/registration.

Registered attendees may access the webcast by visiting the Investor & Media section of the Cytokinetics website at www.cytokinetics.com. The webcast replay will be archived on the Cytokinetics website for six months.

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., China, EU and UK for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive topline results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to discuss the results with the U.S. FDA and other regulatory authorities. 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.

Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757

Authorisation from MRHA and Recommendation from NICE

This announcement is intended for business and financial media and investors only 

SOUTH SAN FRANCISCO, Calif., July 30, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted MYQORZO® (aficamten) a marketing authorisation across the United Kingdom for the treatment of symptomatic (New York Heart Association, NYHA class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in eligible adult patients. At the same time the National Institute for Health and Care Excellence (NICE) has issued guidance recommending aficamten for use in eligible adult patients in England and Wales.

The guidance from NICE states that aficamten can be used as an option to treat symptomatic oHCM in eligible adults with a NYHA class of II to III. It can only be used as an add-on to individually optimised standard care including beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, or alone if these treatments are contraindicated, and if the company provides it according to the commercial arrangement.

“We are pleased to have secured a marketing authorisation for aficamten and to see positive guidance from NICE for eligible adult patients in England and Wales,” said Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics. “We are grateful for the collaborations that made this review possible for concurrent MHRA and NICE decisions and are committed to supporting access for eligible adult patients through the NHS upon availability expected later this year.”

The MHRA assessment of aficamten drew on data from SEQUOIA-HCM, a phase 3 multicentre double-blind placebo-controlled randomised study in 282 adults (142 aficamten, 140 placebo) treated for 24 weeks.1 The primary endpoint was the change from baseline to Week 24 in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing. Aficamten resulted in a statistically significant improvement in peak oxygen uptake compared with placebo (mean change 1.8 mL/kg/min with aficamten versus 0.0 mL/kg/min with placebo; least squares mean difference 1.7 mL/kg/min, 95% confidence interval 1.0 to 2.4; p < 0.001).1 Further information, including efficacy and safety data, is provided in the aficamten Summary of Product Characteristics.2

The most commonly reported adverse reactions with aficamten were hypertension (7.7%), palpitations (7.0%), dizziness (4.2%) and systolic dysfunction (3.5%).2

▼ MYQORZO (aficamten) is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or by searching for MHRA Yellow Card in the Google Play or Apple App Store.

About Aficamten

Aficamten is a cardiac myosin inhibitor authorised in the United Kingdom for the treatment of symptomatic (NYHA class II-III) oHCM in eligible adult patients. In patients with oHCM, myosin inhibition with aficamten reduces cardiac contractility and, consequently, left ventricular outflow tract (LVOT) obstruction. Aficamten has a predictable exposure-response relationship and a reversible mechanism of action.1

About Obstructive Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a disease in which the heart muscle becomes abnormally thick. In oHCM, thickened heart muscle blocks blood flow, and the inside of the left ventricle becomes smaller, stiffer and less able to relax and fill with blood. This 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, affecting approximately 1 out of 500 Europeans, according to European Society of Cardiology guidelines.3 Approximately half of patients with HCM have oHCM.4

People with oHCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.5 People with oHCM are at risk of potentially fatal ventricular arrhythmias, which is one of the leading causes of sudden cardiac death in younger people or athletes.6 A subset of patients with oHCM are at high risk of progressive disease leading to dilated cardiomyopathy and heart failure necessitating cardiac transplantation.

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 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 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., the European Union and the United Kingdom.

References

Maron MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424MYQORZO (aficamten) UK Summary of Product Characteristics. Available from Cytokinetics upon requestESC Clinical Practice Guidelines. ESC European Society of Cardiology. Accessed July 23, 2025. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Cardiomyopathy-GuidelinesButzner M, et al. Epidemiology of Hypertrophic Cardiomyopathy in the United States From 2016 to 2023. JACC Adv. 2026;5(2):102552. doi:10.1016/j.jacadv.2025.102552Gersh BJ, Maron BJ, Bonow RO, Dearani JA, Fifer MA, Link MS, 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