Cytokinetics Launches MYQORZO in Germany After EC Approval, Phase 3 pVO2 Up 1.74 mL/kg/min
CYTK•Cytokinetics began commercial EU launch of MYQORZO in Germany after EC approval in February 2026 for treating NYHA class II-III oHCM. Phase 3 SEQUOIA-HCM showed 1.74 mL/kg/min pVO2 improvement over placebo and significant gains in exercise capacity, symptom scores and LVOT gradients.
1. EU Commercial Launch
On June 1, 2026, Cytokinetics initiated the first European commercial availability of MYQORZO® (aficamten) in Germany. The launch follows European Commission approval granted in February 2026 for treatment of adult patients with symptomatic NYHA class II–III obstructive hypertrophic cardiomyopathy (oHCM).
2. Pivotal Phase 3 SEQUOIA-HCM Data
SEQUOIA‐HCM demonstrated a least‐squares mean pVO2 increase of 1.74 mL/kg/min versus placebo (p=0.000002) over 24 weeks. All ten prespecified secondary endpoints—including KCCQ‐CSS improvements, NYHA class reductions, LVOT gradient decreases and exercise workload gains—reached statistical and clinical significance.
3. Global Approvals and Expansion Plans
MYQORZO received U.S. FDA approval in December 2025 and China NMPA approval shortly thereafter for similar indications. Germany represents the first of several planned EU launches, with additional country rollouts scheduled following local regulatory clearances.
4. Commercial and Competitive Outlook
The EU launch positions Cytokinetics to capture a larger share of the oHCM market against existing therapies. Analysts anticipate German sales could reach tens of millions annually, with further EU penetration bolstering long-term revenue and reinforcing leadership in cardiac myosin inhibition.
