Cytokinetics Expands MYQORZO Access to Canada

Cytokinetics has won Health Canada approval for MYQORZO, its oral cardiac myosin inhibitor, in adults with symptomatic obstructive hypertrophic cardiomyopathy. The South San Francisco company announced the Notice of Compliance on 19 October 2026 — the fifth regulatory approval for the drug, known generically as aficamten, in under a year, following earlier decisions in the United States, China, the European Union and the United Kingdom.

From four muscle biologists to a fifth approval

Aficamten's year of approvals

1. 1997

   Cytokinetics founded

   Founded by Stanford, UCSD and UCSF scientists James Spudich, Ronald Vale, James Sabry and Lawrence S.B. Goldstein to study the cytoskeleton and muscle proteins.

2. 19 December 2025

   First approval, in the U.S.

   FDA approves MYQORZO (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy, based on the SEQUOIA-HCM trial.

3. 17 December 2025

   China's NMPA approves aficamten

   The approval, under Cytokinetics' license and collaboration arrangement covering China and Taiwan, triggers a $7.5 million milestone payment from Sanofi.

4. 2026

   European Commission and UK approvals

   Following a December 2025 CHMP positive opinion, the European Commission approves MYQORZO for the EU; the UK's MHRA separately grants marketing authorization.

5. 19 October 2026

   Health Canada approval

   Health Canada issues a Notice of Compliance for MYQORZO — the fifth regulatory approval for aficamten in under a year.

6. Ahead

   Filings under review elsewhere

   Cytokinetics has disclosed regulatory filings for aficamten under review in Switzerland, Hong Kong and Taiwan, and a planned supplemental filing for non-obstructive HCM.

What Health Canada actually authorized

The Notice of Compliance covers adults with symptomatic obstructive hypertrophic cardiomyopathy classified NYHA class II or III — the same population MYQORZO already serves in the U.S., China and the EU. It is not a new indication and not a new drug: Health Canada's decision extends an existing approval into a new market rather than expanding what aficamten is approved to treat.

“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.” Fady I. Malik, M.D., Ph.D., Executive Vice President of Research and Development, Cytokinetics — 19 October 2026 announcement

MYQORZO's year, in four figures

5thregulatory approval for aficamten in under a year, with Canada

Dec 2025first approval, by the U.S. FDA

1.74mL/kg/min least-squares mean peak-oxygen-uptake benefit vs. placebo at 24 weeks, SEQUOIA-HCM

5.6%serious treatment-emergent adverse events on MYQORZO vs. 9.3% on placebo, SEQUOIA-HCM

Figures from Cytokinetics’ FDA and Health Canada approval announcements and the published SEQUOIA-HCM trial results.

A once-daily pill for a thickened heart

Cytokinetics built MYQORZO on the same cytoskeletal biology the company was founded on: aficamten is a small molecule that selectively and reversibly inhibits cardiac myosin, the motor protein that drives heart-muscle contraction. In obstructive hypertrophic cardiomyopathy, thickened heart muscle contracts with more force than the heart needs, obstructing blood flow out of the left ventricle; by dialing down that excess contractility, aficamten is designed to relieve the obstruction rather than treat it mechanically. Like Bristol Myers Squibb's earlier CAMZYOS (mavacamten), MYQORZO carries a boxed warning for heart-failure risk tied to reduced ejection fraction and is dispensed only through a manufacturer-run REMS program requiring echocardiogram monitoring.

What MYQORZO is selling into Canada with

01

A validated mechanism

Aficamten enters Canada as the second cardiac myosin inhibitor in the class, behind CAMZYOS, rather than as a first-of-kind therapy — physicians and payers already have a reference point for how the drug class works.

02

SEQUOIA-HCM's trial data

The Phase 3 trial reported a 1.74 mL/kg/min least-squares mean improvement in peak oxygen uptake over placebo at 24 weeks, with fewer serious treatment-emergent adverse events on drug (5.6%) than on placebo (9.3%).

03

A four-country head start

Approvals already in hand in the U.S., China, the EU and the UK give Cytokinetics commercial and safety-monitoring experience to carry into a fifth, smaller market.

The cardiac myosin inhibitor race

MYQORZO is entering a category Bristol Myers Squibb effectively created: CAMZYOS, the first cardiac myosin inhibitor approved for obstructive HCM, has become a billion-dollar product, with BMS reporting roughly $729 million in CAMZYOS sales in the first half of 2026 alone. Long-range analyst forecasts for the class have lagged that pace. Standard of care outside the drug class — beta blockers, calcium channel blockers, disopyramide and, for refractory cases, septal reduction procedures such as surgical myectomy or alcohol septal ablation — remains the comparison point for both drugs in patients and payers' decisions.

What analysts expect from the cardiac myosin inhibitor class

$2.42B by 2031

GlobalData's 2031 sales forecast for MYQORZO (aficamten), alongside its forecast for BMS's CAMZYOS (mavacamten), the class's first-in-class drug, per Clinical Trials Arena's ESC 2025 coverage.

CAMZYOS, 2031$2.58B

MYQORZO, 2031$2.42B

Sources: GlobalData, cardiac myosin inhibitor sales forecasts, via Clinical Trials Arena's ESC 2025 coverage · Zacks Equity Research, on Bristol Myers Squibb's reported CAMZYOS sales

Regulatory News outlook

We expect the cardiac myosin inhibitor class to keep tracking toward these forecasts on the strength of CAMZYOS's current sales pace, and we read Canada's approval as extending that growth into a new, smaller market rather than materially changing the U.S. trajectory that drives most of the category's revenue.

How we got here: Bristol Myers Squibb has reported roughly $729 million in CAMZYOS sales in the first half of 2026 alone; annualized to about $1.46 billion for the full year, that run rate is already on pace to clear GlobalData's $2.58 billion 2031 forecast for the same drug well before 2031 if growth continues, which is why we read the class as tracking toward, or ahead of, its own published long-range estimates rather than substitute a number of our own.

MYQORZO against the class it joined second

Product	Mechanism	Dosing	Status	Manufacturer
MYQORZO (aficamten)	Cardiac myosin inhibitor	Once-daily oral, REMS with echocardiogram monitoring	Approved US (Dec 2025), China, EU, UK, Canada (Oct 2026)	Cytokinetics
CAMZYOS (mavacamten)	Cardiac myosin inhibitor	Once-daily oral, REMS with echocardiogram monitoring	Approved US (2022) and other markets; first-in-class	Bristol Myers Squibb
Septal reduction therapy	Surgical or catheter-based (myectomy, alcohol septal ablation)	One-time procedure	Established standard of care for refractory obstruction	Not a single manufacturer

From each company’s own labelling and public disclosures; not a clinical comparison.

What the Canadian launch still needs

A Notice of Compliance authorizes marketing; it does not by itself set a launch date, a price or a reimbursement decision. Cytokinetics' announcement, as reported, frames the approval as laying the foundation for future availability in Canada rather than confirming when the drug ships there, and the company's disclosures do not break out a Canada-specific sales or reimbursement timeline. Aficamten's broader trajectory still depends on pending filings elsewhere and on whether Cytokinetics' planned supplemental filing for non-obstructive HCM, disclosed for the fourth quarter of 2026, succeeds in expanding the approved population beyond obstructive disease.

• What changed: MYQORZO (aficamten) is now authorized in Canada, its fifth regulatory approval in under a year.
• Population: adults with symptomatic obstructive HCM, NYHA class II–III — unchanged from other approved markets.
• Already approved: United States (Dec 2025), China (Dec 2025), European Union and United Kingdom (2026).
• Not yet public: a Canadian launch date, list price or reimbursement timeline, which this article has not independently confirmed.

Frequently asked questions

What did Health Canada approve?

A Notice of Compliance authorizing MYQORZO (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy of NYHA class II–III, announced 19 October 2026. It is a new-country authorization, not a new drug or a new U.S. decision.

Is MYQORZO newly approved, or already on the market elsewhere?

Aficamten first won FDA approval in the United States on 19 December 2025, followed by China's NMPA days later, then the European Commission and the UK's MHRA during 2026. Health Canada's 19 October 2026 authorization is the fifth regulatory approval for the drug in under a year.

How is aficamten different from CAMZYOS (mavacamten)?

Both are oral, once-daily cardiac myosin inhibitors that require echocardiogram monitoring and are dispensed only through a manufacturer REMS program — CAMZYOS from Bristol Myers Squibb, the first-in-class drug approved in 2022, and MYQORZO from Cytokinetics. This article has not independently confirmed any head-to-head efficacy or dosing-simplicity claims between the two.

What is obstructive hypertrophic cardiomyopathy?

A genetic heart condition in which thickened heart muscle obstructs blood flow out of the heart, causing symptoms such as shortness of breath and chest pain; cardiac myosin inhibitors like aficamten and mavacamten target the excess contractility (hypercontractility) that drives the obstruction.