Společnost Cytokinetics získala pro přípravek Myqorzo více než 700 jedinečných poskytovatelů zdravotní péče předepisujících v USA; lék má více než 40% podíl na nových receptech v kategorii inhibitorů srdečního myosinu.
Key Takeaways Cytokinetics' Myqorzo surpassed 700 U.S. prescribers, with over 40% new-to-brand prescription share by Q2.Myqorzo launched in Germany, gained U.K. authorization and could enter additional markets through early 2027.Cytokinetics plans an nHCM filing in Q4 2026, while the FDA set a Nov. 14 action date for its oHCM sNDA.
Cytokinetics, Incorporated (CYTK - Free Report) is making encouraging commercial progress with its lead drug, Myqorzo (aficamten), following its December 2025 approval for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
Adoption continued to expand, supported by growing physician awareness, prescribing activity, patient demand and market access.
More than 700 unique U.S. healthcare providers prescribed Myqorzo as of June 30. More than 80% of dispensed prescriptions were paid, while management’s internal analysis indicated that the drug exited the second quarter with more than 40% new-to-brand prescription share in the cardiac myosin inhibitor category.
Cytokinetics expanded Myqorzo’s international commercial reach with its June launch in Germany, marking the drug’s entry into its first European market. Myqorzo also received marketing authorization in the United Kingdom, where NICE recommended it for use in England and Wales. The company expects to launch the drug in additional markets later this year or in the first half of 2027.
Clinical developments could further strengthen Myqorzo’s growth prospects. Additional results from the phase III ACACIA-HCM study demonstrated improvements in cardiac structure and diastolic function in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). The study had previously met both primary endpoints, showing statistically significant improvements in KCCQ Clinical Summary Score and maximal exercise performance (pVO2) versus placebo.
These findings suggest that aficamten’s potential benefits in nHCM may extend beyond improvements in symptoms and exercise capacity. With no approved therapies currently available for this indication, Cytokinetics plans to submit a supplemental new drug application (sNDA) in the fourth quarter of 2026. The approval could expand Myqorzo’s addressable market.
Separately, the FDA accepted the company’s sNDA based on the phase III MAPLE-HCM study, which evaluated aficamten as monotherapy against metoprolol in patients with oHCM. The FDA assigned a target action date of Nov. 14, 2026.
Continued commercial adoption, potential expansion into nHCM and launches in additional markets could support further Myqorzo sales growth and broaden its market opportunity.
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 its target market, supported by growing demand and broader adoption among eligible patients, potentially boosting BMY’s top line.
The FDA recently approved the drug for treating symptomatic oHCM to improve functional capacity and symptoms in adults and pediatric patients weighing 30 kg (66 lbs) or more.
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.
The company’s pipeline also includes EDG-15400 for heart failure. It recently announced the dosing of the first patient in EQUINOX-HFpEF, a phase II study evaluating EDG-15400 in adults with symptomatic heart failure with preserved ejection fraction who have a left ventricular ejection fraction of at least 50%.
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Health Canada schválila léčivý přípravek MYQORZO od společnosti Cytokinetics pro dospělé pacienty se symptomatickou obstrukční hypertrofickou kardiomyopatií funkční třídy NYHA II–III.
SOUTH SAN FRANCISCO, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Health Canada has issued a Notice of Compliance authorizing MYQORZO® (aficamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) class II-III in adult patients. MYQORZO is a once-daily, oral allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
“This company milestone marks the fifth regulatory approval for MYQORZO in less than a year and lays the foundation for its future availability for patients in Canada,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Cytokinetics is committed to the global HCM community, and we look forward to expanding access to MYQORZO to patients living with oHCM.”
The authorization in Canada, follows the approval of MYQORZO in December 2025 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, and by the China National Medical Products Administration (NMPA) for the treatment of adults with NYHA class II-III oHCM, to improve exercise capacity and symptoms. Earlier in 2026, the European Commission (EC) approved MYQORZO, and the Medicines and Healthcare products Regulatory Agency (MHRA) authorized its use across the United Kingdom.
“Many patients with obstructive HCM have spent years living with breathlessness, fatigue and functional limitations in their everyday lives, with limited options for non-invasive therapy,” said Rafik Tadros, M.D., PhD., Director of the Cardiovascular Genetics Centre at the Montreal Heart Institute. “With improvements in exercise capacity and symptoms observed in SEQUOIA-HCM and a well-tolerated profile, this approval is a major step forward, and I look forward to having it as an option for our patients in Canada.”
The approval by Health Canada is supported by positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated statistically significant and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.1
The results from SEQUOIA-HCM showed that treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.76 mL/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 mL/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 - 2.44]; p=0.000002).1 The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy.
MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low LVEF. Treatment emergent serious adverse events occurred in 5.6% of patients on MYQORZO and 9.3% of patients on placebo. Core laboratory echocardiographic LVEF was observed to be <50% in 5 patients (3.5%) on MYQORZO compared to 1 patient (0.7%) on placebo. Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% of patients and more commonly on MYQORZO than on placebo. MYQORZO-associated increases in blood pressure are consistent with relief of LVOT obstruction and improved cardiac output.
The Product Monograph for MYQORZO includes a Boxed WARNING for the risk of heart failure. MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
Echocardiogram assessments of LVEF and Valsalva left ventricular outflow tract gradient (LVOT-G) are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is ≥40% and <50%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences worsening heart failure due to systolic dysfunction.
For more information about MYQORZO, see the full Product Monograph.
About MYQORZO® (aficamten)
MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China and European Union, United Kingdom and Canada for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.1
Aficamten was studied in ACACIA-HCM, a completed Phase 3 clinical trial of aficamten in patients with nHCM. Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.
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, affecting approximately one out of 350 individuals worldwide.2
Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).3
People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.4 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.5 A subset of patients with HCM 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 patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union, United Kingdom and Canada 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 submit a Supplemental New Drug Application in Q4 2026. 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 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.
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, the United Kingdom and Canada.
References
Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi:10.1016/j.ijcrp.2025.200485.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. Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
Společnost Cytokinetics uvedla, že aficamten v 36. týdnu ve srovnání s placebem významně zlepšil globální výkonnost při zátěži měřenou skóre BEAP-RS u pacientů s neobstrukční hypertrofickou kardiomyopatií.
Additional Analyses from ACACIA-HCM Further Characterize Exercise Performance, Treatment Effect, Dose Titration and Safety of Aficamten in Non-Obstructive HCM
SOUTH SAN FRANCISCO, Calif., Oct. 12, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, AZ.
“These additional analyses from ACACIA-HCM add to the body of evidence supporting the overall benefit-risk profile of aficamten in patients with nHCM,” said Stephen Heitner, M.D., Cytokinetics’ Chief Medical Officer. “The current CPET analysis demonstrates significant improvement in a clinically relevant and novel metric of global exercise performance, while additional data provide insights into dose titration and reinforce our confidence in the safety and treatment effect of aficamten in nHCM. We plan to submit a supplemental New Drug Application to the FDA this quarter.”
ACACIA-HCM: Effect of Aficamten on Comprehensive Exercise Performance
Data from a prespecified analysis of comprehensive exercise performance from ACACIA-HCM were presented in a Late Breaking Clinical Trial Presentation. This analysis examined the effect of aficamten on multiple exercise parameters using the novel 2026 Boston Exercise Aggregate Physiologic Response Score (BEAP-RS). The score captures outputs from five individual domains, ranging from submaximal exercise through to recovery, and generates a composite of global exercise performance. At 36 weeks, treatment with aficamten significantly improved BEAP-RS compared to placebo (p<0.001), with improvements in individual exercise and recovery measures across all five domains. Improvement in BEAP-RS correlated significantly with improvements in health status measured by both Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) (p = 0.001) and New York Heart Association (NYHA) Functional Class (p = 0.001), as well as the cardiac biomarker NT-proBNP (p<0.001). This analysis provides a greater understanding of the complete impact of aficamten on exercise capacity in patients with non-obstructive HCM (nHCM).
ACACIA-HCM: Global Efficacy Responder Analysis
Data from a responder analysis of ACACIA-HCM evaluating the global efficacy of aficamten in patients with symptomatic nHCM were presented in a Late Breaking Clinical Trial Presentation. The results were published in Circulation in August 2026.1 The analysis assessed clinical improvements across five key domains. At 36 weeks, a greater proportion of patients treated with aficamten demonstrated a clinically meaningful response compared to placebo in all five domains, with statistically significant improvements in four domains: relief of limiting symptoms, decrease in left atrial volume index (LAVI), increase in septal e’ velocity and ≥50% reduction in NT-proBNP (all p<0.05). An increase in peak VO2 of at least 0.5 mL/kg/min was observed in 45% of patients on aficamten compared to 37% on placebo (p=0.1). Overall, 53% of patients on aficamten demonstrated a clinical response in three or more domains compared to only 13% of patients on placebo (p<0.001). These data place the primary results into clinical context and underscore the opportunity to impact several aspects of disease burden by addressing the underlying pathobiology in patients living with symptomatic nHCM.
ACACIA-HCM: Dose Titration and Safety
Data related to dose titration and the safety profile of aficamten in ACACIA-HCM were also presented. At the end of the titration period, 80.7% of patients were on 15 or 20 mg. Dose titration led to predictable, dose-proportional changes in plasma concentration of aficamten and reductions in left ventricular ejection fraction (LVEF), which then remained stable from Week 8 through Week 36. LVEF <50% occurred in 27 (10.5%) patients taking aficamten and in two (0.8%) patients taking placebo. The only patient characteristics associated with LVEF <50% were lower baseline LVEF and permanent atrial fibrillation. As previously reported, two participants on aficamten experienced a serious adverse event (SAE) of heart failure associated with LVEF <50%. Ten additional patients on aficamten had SAEs of heart failure not associated with LVEF <50%, for a total of 12 patients (4.7%) compared to three patients (1.2%) on placebo. All heart failure events in patients treated with aficamten occurred during dose titration or prior to Week 12, often following a precipitating event such as rapid atrial fibrillation or infection, and responded to typical medical therapy such as diuretics. Overall, these data suggest that, in ACACIA-HCM, titration of aficamten to the maximum tolerated dose based on LVEF alone was generally well tolerated in the great majority of patients with nHCM.
About MYQORZO® (aficamten)
MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.2
Aficamten was also evaluated in a pivotal Phase 3 clinical trial, ACACIA-HCM, in patients with non-obstructive HCM (nHCM), which met both dual primary endpoints, demonstrating statistically significant improvements in both dual primary endpoints of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and maximal exercise performance (pVO2). Statistically significant improvements compared to placebo were also observed in key secondary endpoints. There were no new safety signals identified. Left ventricular ejection fraction (LVEF) <50% occurred in 10% of participants taking aficamten and in 1% of participants taking placebo. Overall, 12 (4.7 %) patients on aficamten had serious adverse events of heart failure compared to three patients (1.2%) on placebo.
Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.
INDICATION
MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEART FAILUREMYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.
Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.
CONTRAINDICATIONS
MYQORZO is contraindicated with concomitant use of rifampin.
WARNINGS AND PRECAUTIONS
Heart Failure
MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.
Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.
Initiation of MYQORZO in patients with LVEF <55% is not recommended.
MYQORZO REMS Program
MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.
Notable requirements of the MYQORZO REMS Program include:
Prescribers must be certified by enrolling in the MYQORZO REMS ProgramPatients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirementsPharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZOWholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.
Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness
MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (eg, fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (eg, rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.
Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.
ADVERSE REACTIONS
Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% 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 approved in the U.S., including Boxed WARNING.
Please see full Summary of Product Characteristics approved in the European Union.
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, affecting approximately 1 out of 350 individuals worldwide.3
Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).4
People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.5 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.6 A subset of patients with HCM 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 patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. 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 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.
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. Global Efficacy of Aficamten in Nonobstructive Hypertrophic Cardiomyopathy: Results From ACACIA-HCM. Circ. 2026Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi: 10.1016/j.ijcrp.2025.200485Butzner 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, 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 Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
Cytokinetics spustila ASPEN-HCM, prospektivní multicentrickou real-world studii MYQORZO u dospělých se symptomatickou obstrukční hypertrofickou kardiomyopatií. Studie má sledovat bezpečnost, účinnost i ekonomický dopad léčby.
Multi-center Prospective Study to Track Real-World Safety, Clinical Effectiveness, and Healthcare Resource Impact of MYQORZO in Routine Clinical Practice
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced the start of ASPEN-HCM (Aficamten Study of Patient Experience and Novel Outcomes in Symptomatic Obstructive HCM), a prospective, multicenter, observational real-world study evaluating MYQORZO® (aficamten) in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). MYQORZO is a once-daily, oral allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
“We are pleased to announce the start of ASPEN-HCM, marking an important next step in our ongoing commitment to hypertrophic cardiomyopathy research,” said Sanatan Shreay, Ph.D., Cytokinetics’ Executive Director, Head of Health Economics and Outcomes Research. “The clinical trials we conducted of MYQORZO provided strong evidence supporting its approval. Now, this study will build on that foundation by generating valuable real-world insights that can help inform clinical decision-making and support clinicians in their everyday practices.”
Led by the University of California, San Francisco (UCSF), ASPEN-HCM will evaluate the safety and effectiveness of MYQORZO in routine clinical practice to generate prospective, real-world evidence on the clinical and economic impact of treatment.
“With our deep commitment to driving innovation in cardiology, this important study is designed to provide critical insights about the impact of the latest non-invasive treatment in HCM, the most common inherited heart disease,” said Theodore Abraham, M.D., co-director, UCSF HCM Center of Excellence.
ASPEN-HCM: Study Design
This prospective, multicenter, observational real-world study is designed to evaluate the clinical, economic, and patient impact of MYQORZO in adult patients with oHCM across 13 cardiology practices and HCM centers of excellence. Over an anticipated 12-to-36-month period, the study aims to enroll approximately 400 patients to characterize the real-world safety profile of MYQORZO.
The study will evaluate real-world safety and effectiveness outcomes, including reductions in left ventricular ejection fraction (LVEF), treatment discontinuations, changes in in left ventricular outflow tract gradient (LVOT–G), New York Heart Association (NYHA) classification, and patient-reported outcomes.
Secondary study objectives focus on analyzing healthcare resource utilization, conducting pre-and-post economic analyses on hospitalization and procedure rates, and tracking cardiac structural remodeling using parameters like left ventricular mass index and septal thickness.
Additionally, the study will investigate longitudinal treatment patterns, dose titration pathways, the prevalence and incidence of atrial fibrillation, potential predictors of treatment response, and the clinical impact of MYQORZO on avoiding or delaying invasive septal reduction therapy.
To learn more about ASPEN-HCM, visit www.clinicaltrials.gov.
The full U.S. Prescribing Information for MYQORZO includes a Boxed WARNING for the risk of heart failure. MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction. Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program. Please see additional Important Safety Information including Boxed WARNING below.
About MYQORZO® (aficamten)
MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., China, European Union and United Kingdom for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. MYQORZO was engineered to achieve a predictable exposure response, rapid onset of action and reversibility.3
Aficamten is also under clinical investigation in CEDAR-HCM in a pediatric population with oHCM. Safety and efficacy of aficamten have not been established in a pediatric patient population. In addition, aficamten is being studied in FOREST-HCM, an open-label extension clinical study.
INDICATION
MYQORZO is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF HEART FAILUREMYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
Echocardiogram assessments are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF <55% is not recommended. Decrease the dose of MYQORZO if LVEF is <50% and ≥40%. Interrupt the dose of MYQORZO if LVEF <40% or if the patient experiences heart failure symptoms or worsening clinical status due to systolic dysfunction.
Because of the risk of heart failure due to systolic dysfunction, MYQORZO is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program.
CONTRAINDICATIONS
MYQORZO is contraindicated with concomitant use of rifampin.
WARNINGS AND PRECAUTIONS
Heart Failure
MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure.
Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., new or uncontrolled atrial fibrillation) may be at greater risk of developing systolic dysfunction and heart failure.
Assess patients’ clinical status and LVEF prior to and during treatment and adjust the MYQORZO dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide may be signs and symptoms of heart failure.
Initiation of MYQORZO in patients with LVEF <55% is not recommended.
MYQORZO REMS Program
MYQORZO is available only through a restricted program called the MYQORZO REMS Program, because of the risk of heart failure due to systolic dysfunction.
Notable requirements of the MYQORZO REMS Program include:
Prescribers must be certified by enrolling in the MYQORZO REMS ProgramPatients must enroll in the MYQORZO REMS Program and comply with ongoing monitoring requirementsPharmacies must be certified by enrolling in the MYQORZO REMS Program and must only dispense to patients who are authorized to receive MYQORZOWholesalers and distributors must only distribute to certified pharmacies Further information is available at www.MYQORZOREMS.com, or at 1-844-285-7367.
Cytochrome P450 Interactions Leading to Heart Failure or Loss of Effectiveness
MYQORZO is metabolized primarily by CYP2C9, and to a lesser extent by CYP3A, CYP2D6, and CYP2C19 enzymes. Initiation of medications that inhibit multiple P450 pathways of MYQORZO elimination (e.g., fluconazole, voriconazole, or fluvoxamine) or strong CYP2C9 inhibitors, and discontinuation of moderate-to-strong CYP3A inducers may lead to increased blood concentrations of aficamten and increase the risk of heart failure due to systolic dysfunction. Conversely, initiation of medications that induce P450 pathways of MYQORZO (e.g., rifampin, moderate-to-strong CYP3A inducers) may lead to decreased blood concentrations of aficamten and potential loss of effectiveness. Assess LVEF 2 to 8 weeks after initiation of such inhibitors or after discontinuation of such inducers and adjust the dose of MYQORZO accordingly.
Advise patients of the potential for drug interactions. Advise patients to inform their healthcare provider of all concomitant medications prior to and during MYQORZO treatment.
ADVERSE REACTIONS
Hypertension (8% vs 2%) was the only adverse reaction occurring in >5% 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 approved in the U.S., including Boxed WARNING.
Please see full Summary of Product Characteristics approved in the European Union.
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, affecting approximately one out of 350 individuals worldwide.1
Approximately half of patients with HCM have obstructive HCM (oHCM) and half have non-obstructive HCM (nHCM).2.
People with HCM are at high risk of also developing cardiovascular complications including atrial fibrillation, stroke and mitral valve disease.3 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.4 A subset of patients with HCM 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 patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the approved in the U.S., China, European Union and United Kingdom for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Following positive results in ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM (nHCM), the company plans to submit a Supplemental New Drug Application in Q4 2026. 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 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.
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
Tsenov et al. Healthcare access, symptom burden, and psychological impact in hypertrophic cardiomyopathy: a multinational patient-driven survey. Int J Cardiol Cardiovasc Risk Prev2025 Aug 4;27:200485. doi:10.1016/j.ijcrp.2025.200485.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. Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
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.
Cytokinetics oznámila, že aficamten ve 3. fázi studie ACACIA-HCM významně zlepšil příznaky i výkon při zátěži u pacientů se symptomatickou neobstrukční hypertrofickou kardiomyopatií. Firma chce podat doplňkovou žádost FDA ve 4. čtvrtletí roku 2026.
Cytokinetics Incorporated (NASDAQ:CYTK) on Friday shared primary results from the ACACIA-HCM Phase 3 clinical trial of aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).
The data showed aficamten significantly improved symptoms and exercise performance in patients suffering from symptomatic non-obstructive hypertrophic cardiomyopathy.
Meeting Primary EndpointsThe ACACIA-HCM clinical study successfully achieved its dual primary endpoints. Researchers observed substantial enhancements in patients over 36 weeks when comparing the active treatment to a placebo.
Trial participants reported notably better scores on the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, indicating a reduction in disease symptoms.
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Patients also displayed increased maximal exercise performance. Furthermore, these positive findings remained consistent across all predetermined patient subgroups evaluated during the study.
Evaluating Broad Clinical BenefitsDuring the European Society of Cardiology Congress 2026 in Munich, researchers presented an additional assessment detailing the overall effectiveness of the treatment across five vital medical areas.
These domains included exercise capacity, cardiac structure, cardiac biomarkers, diastolic function, and overall symptom burden.
At the 36-week mark, individuals taking aficamten demonstrated statistically significant progress in all five categories compared to the placebo group.
Notably, 53% of the treated patients achieved a clinical response in three or more measurement areas, whereas only 13% of the placebo group reached the same milestone.
Stock ReactionCiting analysts, Reuters noted that the drug did not significantly improve heart structure or delay cardiovascular events.
About 10% of the patients also experienced a drop in their heart’s pumping capacity, and 12 events of heart failure also occurred during the study.
“Investors might be reacting to the size of the win, not whether it won,” B. Riley Securities analyst Mayank Mamtani told Reuters.
“There was an imbalance of heart failure events early on in the study,” Cytokinetics Chief Medical Officer Stephen Heitner told Reuters.
Regulatory Next StepsMedical professionals simultaneously published the primary data in The New England Journal of Medicine and the sub-analysis in Circulation.
Cytokinetics intends to file a supplemental New Drug Application with the U.S. Food and Drug Administration in the fourth quarter of 2026 for symptomatic non-obstructive hypertrophic cardiomyopathy.
CYTK Price Action: Cytokinetics shares were down 3.19% at $69.79 at the time of publication on Monday, according to Benzinga Pro data.
Cytokinetics oznámila, že na kongresu ESC, který se koná 28.–31. srpna 2026 v Mnichově, představí hlavní výsledky studie ACACIA-HCM s aficamtenem u pacientů s neobstrukční hypertrofickou kardiomyopatií. Současně uspořádá investorskou akci v Mnichově 28. srpna 2026 ve 14:00 CEST.
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.
Cytokinetics (CYTK - Free Report) came out with a quarterly loss of $1.5 per share versus the Zacks Consensus Estimate of a loss of $1.63. This compares to a loss of $1.12 per share a year ago. These figures are adjusted for non-recurring items.
This quarterly report represents an earnings surprise of +7.98%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $1.67 per share when it actually produced a loss of $1.67, delivering no surprise.
Over the last four quarters, the company has surpassed consensus EPS estimates two times.
Cytokinetics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $28.62 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 40.20%. This compares to year-ago revenues of $66.77 million. The company has topped consensus revenue estimates three times over the last four quarters.
The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.
Cytokinetics shares have added about 24.1% since the beginning of the year versus the S&P 500's gain of 12.8%.
What's Next for Cytokinetics?While Cytokinetics has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?
There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.
Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.
Ahead of this earnings release, the estimate revisions trend for Cytokinetics was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$1.63 on $30.27 million in revenues for the coming quarter and -$6.20 on $114.87 million in revenues for the current fiscal year.
Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.
One other stock from the same industry, Gyre Therapeutics, Inc. (GYRE - Free Report) , is yet to report results for the quarter ended June 2026.
This company is expected to post quarterly loss of $0.08 per share in its upcoming report, which represents a year-over-year change of -500%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.
Gyre Therapeutics, Inc.'s revenues are expected to be $26.24 million, down 2% from the year-ago quarter.
Cytokinetics získala v Británii schválení pro MYQORZO (aficamten) k léčbě symptomatické (NYHA třída II–III) obstrukční hypertrofické kardiomyopatie u způsobilých dospělých pacientů. NICE zároveň doporučila jeho použití v Anglii a Walesu pro způsobilé dospělé pacienty.
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
Cytokinetics oznámila tři late-breaking abstrakty na kongresu ESC, včetně Hot Line prezentace primárních výsledků studie ACACIA-HCM s aficamtenem u pacientů s neobstrukční hypertrofickou kardiomyopatií. Firma chystá i investorskou akci k jejich výsledkům.
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., July 07, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced three Late Breaking Science abstracts were accepted for presentation at the European Society of Cardiology (ESC) Congress, taking place August 28-31 in Munich, Germany, including a Hot Line presentation of the primary results from ACACIA-HCM, the pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive hypertrophic cardiomyopathy (HCM).
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 – 12:15 PM CEST
Presentation Time: 11:45 – 11:55 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: Achgabat (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: Achgabat (Hall A3)
Investor Event and Webcast
Cytokinetics will host an in-person and virtual investor event onsite at ESC to discuss results from the Late-Breaking Science presentations at the Congress. Additional details including the date, time and registration information will be announced at a later date.
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., Europe and China 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.
