Cytokinetics Wins EU Approval for Cardiovascular Drug Myqorzo

Cytokinetics, Incorporated CYTK announced that the European Commission (EC) has approved Myqorzo (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets, for the treatment of adult patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

CYTK is currently gearing up to make Myqorzo available in the EU, beginning with the first launch in Germany in the second quarter of 2026. The EC approval was expected as the European Medicines Agency’s advisory committee had earlier issued a positive opinion recommending marketing authorization in the EU for Myqorzo to treat symptomatic oHCM in adult patients. 

Please note that in late December, the FDA also approved Myqorzo for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms. This marked the company’s first FDA-approved product, transforming Cytokinetics from a development-stage biotech into a commercial-stage company. The drug is also approved in China for the treatment of adults with symptomatic oHCM to improve exercise capacity and symptoms.

More on CYTK’s Cardiovascular Drug

Myqorzo is an allosteric, reversible inhibitor of cardiac myosin motor activity. It is designed to address the underlying pathophysiology of oHCM. By reducing cardiac contractility, the drug lowers left ventricular outflow tract obstruction, a primary driver of symptoms, such as shortness of breath, chest pain and exercise intolerance.

The EC approval was supported by robust results from the pivotal phase III study SEQUOIA-HCM. Myqorzo demonstrated statistically significant and clinically meaningful improvements in exercise capacity, increasing peak oxygen uptake (pVO2) by 1.8 mL/kg/min at 24 weeks, compared to baseline in patients treated with Myqorzo versus 0.0 mL/kg/min in patients treated with placebo.

Benefits were consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy.

Cytokinetics shares have surged 76.1% in the last six months compared with the industry’s 21.4% growth.

From a safety perspective, Myqorzo was generally well tolerated. Over the 24-week treatment period, 3.5% of patients receiving the therapy experienced a reversible, dose-dependent decline in left ventricular ejection fraction (LVEF) to below 50%. One patient in the treatment arm developed an asymptomatic LVEF below 40%. These reductions to below 50% did not necessitate treatment discontinuation and were not linked to clinical heart failure.

The most frequently reported adverse reactions with Myqorzo included dizziness, systolic dysfunction defined as LVEF below 50%, palpitations and hypertension.

What Does the Approvals Mean for CYTK?

The approvals of Myqorzo in the United States, the EU and China are a significant boost for CYTK, given the market potential for oHCM.

The oHCM market represents a meaningful commercial opportunity, with a substantial population of symptomatic patients who have historically had limited pharmacologic options beyond beta-blockers, calcium channel blockers, or invasive procedures. The approvals position Cytokinetics as a key player in this growing specialty cardiology segment.

Hypertrophic cardiomyopathy (HCM) is the most prevalent monogenic inherited cardiovascular disease. Approximately half of all HCM patients have oHCM, while the remaining half have non-obstructive HCM.

The drug has already been made available in the United States and China, setting the stage for near-term revenue generation.

However, the successful commercialization of the drug holds the key.

Myqorzo will face competition from Camzyos (mavacamten), a first-in-class cardiac myosin inhibitor marketed by Bristol Myers Squibb BMY.

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

Camzyos has put up a stellar performance since approval.

Cytokinetics, Incorporated Price and Consensus

Cytokinetics, Incorporated price-consensus-chart | Cytokinetics, Incorporated Quote

CYTK’s Zacks Rank & Stocks to Consider

Cytokinetics currently carries a Zacks Rank #3 (Hold). 

Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Alkermes ALKS, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.72 to $4.00. HRMY shares have surged 1.5% over the past six months.

Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, with the average surprise being 7.20%.

Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 14% over the past six months.

Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.

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