Cytokinetics Announces Positive Results from ACACIA-HCM Presented in Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 and Published in The New England Journal of Medicine
Cytokinetics announced positive top-line results from the Phase 3 ACACIA-HCM trial, demonstrating that aficamten met both dual primary endpoints with statistically significant improvements in patient-reported symptoms and exercise capacity compared to placebo. Based on these results, which were simultaneously published in The New England Journal of Medicine, the company plans to submit a supplemental New Drug Application to the FDA for the non-obstructive HCM indication in the fourth quarter of 2026.
Key figures
- Drug Name
- aficamten
- Phase Of Trial
- Phase 3
- P value pvo2
- 0.003
- P value kccq css
- 0.021
- Kccq css difference
- 3.0 (0.5 - 5.5)
- Patients randomized
- 517
- Sae rate placebo pct
- 14.7%
- Sae rate aficamten pct
- 20.2%
- Pvo2 difference ml kg min
- 0.67 (0.22 - 1.1)
- Lvef under 50 aficamten pct
- 10.5%
- Clinical response 3 plus measures aficamten pct
- 53
AI analysis
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