Cytokinetics Announces Health Canada Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

The Canadian authorization follows approvals in four other jurisdictions and carries a boxed warning for heart failure.

Rhea-AI Summary

Cytokinetics (Nasdaq: CYTK) received Health Canada approval for MYQORZO to treat adults with symptomatic obstructive hypertrophic cardiomyopathy, a heart-muscle thickening disorder. The authorization covers New York Heart Association class II-III disease and follows approvals in the U.S., China, European Union and United Kingdom.

Approval was supported by the Phase 3 SEQUOIA-HCM trial. After 24 weeks, peak oxygen uptake increased from baseline by 1.76 mL/kg/min with MYQORZO versus 0.0 mL/kg/min with placebo; the adjusted difference was 1.74 mL/kg/min (p=0.000002). Treatment-emergent serious adverse events occurred in 5.6% versus 9.3%, respectively. However, the Canadian product monograph includes a boxed warning for heart failure: MYQORZO can reduce the proportion of blood pumped out of the left ventricle with each beat. Heart ultrasound assessments are required before and during treatment.

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0 major · 3 points

How the balance works

Positive

• Major pointHealth Canada approval authorizes MYQORZO for adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy.
• Major pointPeak oxygen uptake improved versus placebo at 24 weeks: adjusted difference 1.74 mL/kg/min, p=0.000002.
• Minor pointTreatment effects were consistent across all prespecified subgroups, including patients with and without background beta-blocker therapy.
• Minor pointTreatment-emergent serious adverse events occurred in 5.6% on MYQORZO versus 9.3% on placebo.
• Minor pointNo worsening heart failure or treatment interruptions due to low LVEF occurred in SEQUOIA-HCM.

Negative

• Moderate pointBoxed heart-failure warning states MYQORZO can cause systolic dysfunction; heart ultrasound monitoring is required before and during treatment.
• Minor pointLeft ventricular ejection fraction below 50% occurred in 5 MYQORZO patients (3.5%) versus 1 placebo patient (0.7%).
• Minor pointHypertension occurred in 8% on MYQORZO versus 2% on placebo.

Key Figures

Regulatory approvals: 5 approvals Treatment period: 24 weeks Peak oxygen uptake change: 1.76 mL/kg/min vs 0.0 mL/kg/min +5 more

Regulatory approvals

5 approvals

MYQORZO in less than a year, as stated in the article

Treatment period

24 weeks

SEQUOIA-HCM

Peak oxygen uptake change

1.76 mL/kg/min vs 0.0 mL/kg/min

MYQORZO vs placebo, change from baseline in SEQUOIA-HCM

LSM difference in peak oxygen uptake

1.74 mL/kg/min

MYQORZO vs placebo in SEQUOIA-HCM

P-value

p=0.000002

Peak oxygen uptake result in SEQUOIA-HCM

Treatment-emergent serious adverse events

5.6% vs 9.3%

MYQORZO vs placebo

LVEF below 50%

3.5% vs 0.7%

MYQORZO vs placebo

Hypertension

8% vs 2%

MYQORZO vs placebo; only adverse reaction occurring in more than 5% and more commonly on MYQORZO

Key Terms

notice of compliance, lvot, pvo2, cardiopulmonary exercise testing, +2 more

6 terms

notice of compliance regulatory

"Health Canada has issued a Notice of Compliance authorizing MYQORZO"

A notice of compliance is an official letter from a health regulator saying a drug or medical device has met the agency’s requirements and can be marketed. For investors, it’s like a product earning its commercial license: it opens the door to sales and revenue while reducing the regulatory risk that could have blocked the product’s launch.

lvot medical

"left ventricular outflow tract (LVOT) obstruction"

Left ventricular outflow tract (LVOT) is the passage inside the heart through which blood exits the left ventricle to reach the aorta; think of it as the exit ramp that directs traffic out of the heart. For investors, LVOT anatomy and function matter because many cardiac devices and procedures must fit or preserve that passage—issues there can affect safety, treatment success, regulatory approval, and commercial adoption of related products.

pvo2 medical

"peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing"

PvO2 is the partial pressure of oxygen in venous blood — a measure of how much oxygen remains in the blood after tissues have taken what they need. Think of it like checking the water level in a used bucket to gauge how much was consumed; low PvO2 can signal poor oxygen delivery or high tissue demand, while high PvO2 can mean reduced uptake. Investors watch PvO2 when it’s used as a clinical measurement or trial endpoint because changes can indicate whether a drug, device, or treatment meaningfully improves patient oxygenation and safety, which affects regulatory decisions and market value.

cardiopulmonary exercise testing medical

"measured by cardiopulmonary exercise testing (CPET)"

A test that measures how well the heart, lungs and muscles work together under physical stress by monitoring breathing, oxygen use, heart rate and blood pressure while a person walks or pedals. It matters to investors because it provides objective, quantifiable evidence of a therapy’s or device’s real-world benefit, helps regulators judge effectiveness, and can drive demand for diagnostics, equipment and treatments—like a performance bench test for medical products.

lvef medical

"due to low LVEF"

Left ventricular ejection fraction (LVEF) is a percentage that measures how much blood the heart’s main pumping chamber pushes out with each beat, like the share of water a pump empties from a bucket each cycle. Investors watch LVEF because it’s a key medical yardstick used to diagnose and track heart function, shaping demand for drugs, devices, clinical trials, insurance costs and the financial outlook of healthcare-related businesses.

boxed warning regulatory

"includes a Boxed WARNING for the risk of heart failure"

A boxed warning is the strongest safety alert a drug regulator places on a medication’s official label to highlight life‑threatening or very serious risks, similar to a bold red flag attached to a product. For investors, it matters because this warning can reduce sales, increase regulatory scrutiny, raise liability and monitoring costs, and change market perception of the drug’s future revenue and risk profile.

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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

1. Maron, MS, et al. Aficamten for Symptomatic Obstructive Hypertrophic Cardiomyopathy. N Engl J Med. doi:10.1056/NEJMoa2401424
2. 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.
3. 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.
4. 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.
5. 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Health Canada approve Cytokinetics' MYQORZO to treat?

Health Canada authorized MYQORZO (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy of New York Heart Association class II-III. The authorization was issued through a Notice of Compliance.

What did the SEQUOIA-HCM trial show for Cytokinetics' MYQORZO?

At 24 weeks, peak oxygen uptake increased from baseline by 1.76 mL/kg/min with MYQORZO versus 0.0 mL/kg/min with placebo. The least-squares mean difference was 1.74 mL/kg/min, with a 95% confidence interval of 1.04–2.44 and p=0.000002.

What heart-function thresholds apply to MYQORZO treatment in Canada?

Starting MYQORZO is not recommended when left ventricular ejection fraction is below 55%. The dose should be decreased when this measure is at least 40% but below 50%, and interrupted below 40% or if worsening heart failure due to systolic dysfunction occurs.