Cytokinetics, Incorporated CYTK 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 Myqorzo
Myqorzo operates within an evolving treatment landscape for oHCM. Its primary branded competitor is Camzyos, a cardiac myosin inhibitor marketed by Bristol Myers Squibb BMY. 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, 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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