other material
confidence high
sentiment positive
materiality 0.75
Cytokinetics presents new aficamten data at ESC 2025; shows improvement vs metoprolol
CYTOKINETICS INC
- MAPLE-HCM: aficamten superior to metoprolol on diastolic function, SAM, and LVOT obstruction (p<0.001); reduced max wall thickness (-1.01mm, p=0.015).
- Atrial fibrillation annual incidence with aficamten was 1.5%, consistent with predicted HCM-AF and CHARGE-AF rates; minimal clinical impact.
- Integrated safety of 463 patients (~700 patient-years) shows similar AE profile to placebo; low LVEF<50% incidence, no permanent discontinuations.
- Longer-term FOREST-HCM: 69% and 93% of patients improved NYHA class at Week 12 and 96; KCCQ-CSS +15 and +16.
- FDA NDA under review with PDUFA target action date of December 26, 2025.