---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-372456"
form_type: "8-K"
ticker: "CYTK"
cik: "0001061983"
company_name: "CYTOKINETICS INC"
filed_at: "2026-08-28T13:21:49+00:00"
generated_at: "2026-08-28T13:24:12.396885+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Cytokinetics' aficamten meets both primary endpoints in Phase 3 ACACIA-HCM nHCM trial

## Summary
- ACACIA-HCM met both dual primary endpoints: KCCQ-CSS LSM diff 3.0 (p=0.021) and pVO2 diff 0.67 ml/kg/min (p=0.003) at Week 36.
- First Phase 3 trial to show statistically significant improvements in non-obstructive HCM; results published in NEJM and presented at ESC 2026.
- sNDA for aficamten in symptomatic nHCM to be submitted to FDA in Q4 2026.
- Safety: LVEF <50% in 10.5% of aficamten patients vs 0.8% placebo; SAEs 20.2% vs 14.7%.
- Global efficacy: 53% of aficamten patients responded in 3+ outcome measures vs 13% placebo (p<0.001).

## SEC filing metadata
- accession: 0001193125-26-372456
- form_type: 8-K
- ticker: CYTK
- cik: 0001061983
- company_name: CYTOKINETICS INC
- filed_at: 2026-08-28T13:21:49+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1061983/000119312526372456/0001193125-26-372456-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1061983/000119312526372456/cytk-20260828.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-372456
- JSON: https://secwatch.observer/filing/0001193125-26-372456.json
- Plain text: https://secwatch.observer/filing/0001193125-26-372456.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.