Regulatory Approvals and Global Commercial Transition
MYCorzo (aficamten) received FDA approval in the U.S., approval in China, a positive CHMP opinion and subsequent European Commission approval for the EU during the same week — enabling Cytokinetics' transition to a global commercial-stage company and planned first European launch in Germany in Q2 2026.
Early U.S. Commercial Launch Momentum
Commercial launch activities began immediately after FDA approval with REMS portal and patient support program live; first prescriptions dispensed within days and patients on therapy within the first week. Within three weeks, over 700 HCPs were REMS-certified and the company reported over 12,000 customer engagements, with Cardiovascular Account Specialists engaging over 95% of the 700 HCPs identified as high-prescribers.
Strong Full-Year Revenue Lift Driven by Collaborations and Milestones
Total revenues for full-year 2025 were $88.0M versus $18.5M in 2024, an increase of approximately +376%, primarily due to a $52.4M technology transfer to Bayer and $15.0M in approval-related milestones under the Sanofi license agreement.
Robust Cash Position Entering Commercial Phase
Year-end 2025 cash, cash equivalents and investments totaled approximately $1.22B (versus $1.25B at year-end 2024). The 2025 balance included a $100M drawing from the Royalty Pharma loan; excluding that draw, cash would have declined by about $134M during 2025.
Clinical Development Milestones and Trial Progress
Key near-term clinical milestones: topline results for ACACIA-HCM (non-obstructive HCM) expected in Q2 2026; sNDA for MAPLE-HCM submitted with FDA review expected by Q4 2026; Health Canada review accepted with potential approval later in 2026. Ongoing trials: COMMUN-HF has 100% U.S. site activation and >90% European site activation; AMBER-HFpEF cohort one enrollment expected complete Q1 2026.
Positive Clinical Data Narrative
MAPLE-HCM responder analyses showed significantly more patients on aficamten achieved positive responses vs metoprolol, with greater improvements in symptoms and cardiac biomarkers — results that have resonated in the cardiology community and support commercial messaging.
Launch Targets and Strategic Priorities
Company aims to achieve >50% of CMI new patient preference share by 2026, intends to grow the overall CMI category, and set capital allocation priorities on US launch, European readiness, label-expansion opportunities, and advancing pipeline programs.