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Cytokinetics reported its first full quarter with a commercial product on the U.S. market and, in the same update, told investors when it expects to seek approval in a second, larger patient group.
The clinical-stage cardiovascular drugmaker posted second-quarter results Aug. 6, booking $25.3 million in net product revenue from MYQORZO, its heart-disease therapy, and said it plans to file for a new indication before year-end. Armistice Capital and several other funds hold positions in the company, whose next catalyst comes later this month at Europe's largest cardiology meeting.
MYQORZO (aficamten) generated $25.3 million in net product revenue in the quarter, $23.0 million in the United States and $2.3 million in Europe, where the figure reflected initial inventory following the drug's German launch, the company reported. More than 700 health-care providers had prescribed the drug and about 1,500 patients had been dispensed it for symptomatic obstructive hypertrophic cardiomyopathy, the condition for which it won U.S. approval in December 2025.
MYQORZO has since been approved in the United Kingdom and cleared for reimbursement in the Netherlands, and Cytokinetics said it had submitted 10 health-technology-assessment dossiers and expects launches in more than five additional markets by the first half of 2027. Total revenue was $28.6 million, down from $66.8 million a year earlier, when the figure included larger collaboration revenue; the quarter turned on the launch rather than the year-over-year comparison.
The update also set a timeline for aficamten's next indication. Cytokinetics said it expects to submit a supplemental new drug application for non-obstructive hypertrophic cardiomyopathy in the fourth quarter of 2026, drawing on the Phase 3 ACACIA-HCM trial. Non-obstructive HCM has no approved therapy aimed at the hypercontractility that drives it, so a filing would carry aficamten toward a second patient population larger than the obstructive form it already treats.
The full ACACIA-HCM results are set for a Hot Line presentation at the European Society of Cardiology Congress in Munich, which runs Aug. 28-31; the company said in early July that Dr. Ahmad Masri of Oregon Health & Science University would present the data Friday, Aug. 28.
When Cytokinetics reported topline results in May, ACACIA-HCM had tested aficamten against placebo in 516 patients with symptomatic non-obstructive HCM and met both dual primary endpoints at Week 36. Patients on aficamten improved 11.4 points on the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, a measure of symptoms and physical limitation, against 8.4 for placebo, and their peak oxygen uptake, a gauge of exercise capacity, rose 0.64 mL/kg/min while the placebo group slipped 0.03. Several key secondary endpoints, among them improvement in NYHA functional class and reductions in the cardiac biomarker NT-proBNP, also reached statistical significance, and the company reported no new safety signals.
Cytokinetics ended June with about $1.7 billion in cash and investments, up from $1.1 billion three months earlier after a stock offering, and raised its full-year forecast for combined research-and-development and administrative spending to a range of $860 million to $890 million. The company's register runs from index managers such as Vanguard, BlackRock and State Street to specialist health-care investors including T. Rowe Price and Wellington Management, with hedge funds such as Armistice Capital also reporting a position. With the launch underway and a filing planned, the near-term focus turns to the ACACIA-HCM data in Munich and the regulatory steps that follow.
