Cytokinetics (NASDAQ:CYTK) reported $44.5 million in third-quarter net revenue from heart drug MYQORZO, up 76% from the prior quarter, as the company prepares regulatory submissions that could expand the treatment’s use.
President and CEO Robert Blum said the launch, nearly nine months in, continues to exceed the company’s expectations. Cytokinetics is seeking to build on that momentum with a planned U.S. application this quarter for patients with symptomatic non-obstructive hypertrophic cardiomyopathy, or nHCM.
MYQORZO, also known as aficamten, is available in the U.S. for adults with symptomatic obstructive hypertrophic cardiomyopathy, or oHCM. An FDA decision on a separate supplemental application based on the MAPLE-HCM study is expected by Nov. 14.
Prescribing and patient demand grow
Nearly 1,100 U.S. health care providers had prescribed MYQORZO by the end of the third quarter, up from more than 700 at the end of the second quarter, Chief Commercial Officer Andrew Callos said. The drug had been dispensed to more than 2,800 patients, up approximately 86% from 1,500 three months earlier.
Callos said the company’s internal analysis suggested MYQORZO’s new-to-brand exit share in the cardiac myosin inhibitor category was approaching 45% in the third quarter, compared with approximately 40% in the second. Cytokinetics maintained its goal of exceeding 50% by year-end.
The company estimates that about 28,000 of approximately 120,000 eligible U.S. oHCM patients are treated with a cardiac myosin inhibitor. Callos said growth in the category has come largely from providers who had not prescribed those drugs before the MYQORZO launch. Switching from another treatment accounted for a mid-single-digit percentage of MYQORZO patients, he said.
Commercial insurance coverage expanded to more than 60% of covered lives at quarter-end, from 50% at the end of the second quarter, according to Callos. In Germany, MYQORZO had captured more than 50% of new cardiac myosin inhibitor patient starts by the end of August, he said.
Cytokinetics expects to launch in the U.K. this quarter and in additional countries in 2027. Callos said Europe could account for about 15% of MYQORZO revenue when the European and U.S. markets mature, with more meaningful European revenue likely in 2028 and 2029 as reimbursement processes progress.
Expansion application and safety monitoring
The planned nHCM submission is based on the Phase 3 ACACIA-HCM trial. Fady Malik, executive vice president of research and development, said aficamten met both primary endpoints, showing statistically significant improvements over placebo in patient-reported health status and exercise capacity. It also achieved significance on three of five key secondary endpoints.
Malik said an analysis found that heart failure events occurred early during dose titration, often after a triggering event such as atrial fibrillation or infection, and generally resolved with standard therapy. He said such events have been rare in the open-label FOREST-HCM extension, where patient judgment guides dose titration.
The company plans to submit an application to the European Medicines Agency in early 2027. In the U.S., Callos estimated that more than 200,000 patients have been diagnosed with nHCM, including over 120,000 who are symptomatic and eligible for treatment. Any expansion of MYQORZO into that indication remains subject to regulatory approval.
Asked about the potential to simplify MYQORZO’s risk evaluation and mitigation strategy, or REMS, Malik said real-world data could support changes over a two- to three-year period. Blum said the company believes evidence from a larger number of patients will be important to pursuing a relaxed or potentially removed REMS.
Chief Medical Officer Steve Heitner said Cytokinetics recently began ASPEN-HCM, a real-world study intended to assess safety, effectiveness and health care resource use and to help inform future regulatory discussions, particularly around the REMS.
Loss narrows as launch spending rises
Total third-quarter revenue rose to $47.6 million from $1.9 million a year earlier. MYQORZO contributed $43.1 million in U.S. net product revenue and $1.4 million in Europe, Chief Financial Officer Sung Lee said.
The net loss narrowed to $190.1 million, or $1.37 per share, from $306.2 million, or $2.55 per share, a year earlier. Research and development expenses increased to $99.3 million from $97.3 million, while selling, general and administrative expenses rose to $113.1 million from $69.5 million, primarily because of launch-related and personnel costs.
Cytokinetics ended the quarter with approximately $1.6 billion in cash and investments, down from $1.7 billion at the end of the second quarter. It reaffirmed full-year 2026 combined GAAP research and development and selling, general and administrative expense guidance of $860 million to $890 million.
Pipeline milestones ahead
Heitner said enrollment in COMET-HF, a Phase 3 trial of omecamtiv mecarbil in patients with heart failure and severely reduced ejection fraction, is expected to continue through 2027. Malik clarified during the question-and-answer session that the company had not expected enrollment to conclude in 2026.
For ulacamten, Cytokinetics expects to complete enrollment this quarter in the first cohort of the Phase 2 AMBER-HFpEF study. Malik said data from that cohort, which is focused on dose finding, safety and tolerability, are expected in 2027. The company also expects top-line results from the adolescent cohort of its CEDAR-HCM aficamten study in early 2027.
About Cytokinetics (NASDAQ:CYTK)
Cytokinetics, Incorporated is a biopharmaceutical company focused on discovering and developing medicines that target muscle function and contractility. The company applies muscle biology and sarcomere science to develop potential treatments for cardiovascular and neuromuscular diseases, including conditions in which impaired muscle performance contributes to disease progression.
Its leading investigational program is aficamten, a selective cardiac myosin inhibitor being developed for hypertrophic cardiomyopathy and other potential cardiovascular indications.
