{"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","discovered_at":"2026-08-28T13:24:03.872091+00:00","generated_at":"2026-08-28T13:24:12.396885+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Cytokinetics' aficamten meets both primary endpoints in Phase 3 ACACIA-HCM nHCM trial","bullets":["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)."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-372456","json":"https://secwatch.observer/filing/0001193125-26-372456.json","markdown":"https://secwatch.observer/filing/0001193125-26-372456.md","text":"https://secwatch.observer/filing/0001193125-26-372456.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-28T13:24:12.396885+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}