8-K/A
filed September 8, 2025, 7:59 PM ET
ticker CYTK
CIK 0001061983
other material
confidence high
sentiment positive
materiality 0.75
Cytokinetics presents positive aficamten data at ESC 2025; PDUFA Dec 26, 2025
CYTOKINETICS INC
- MAPLE-HCM: aficamten improved cardiac structure/function vs metoprolol (p<0.001 for diastolic function, SAM reduction); published in JACC.
- New analysis shows aficamten AF incidence 1.5%/year, consistent with HCM prediction model (3.6%/year) and healthy model (1.4%/year); published in Heart Rhythm.
- FOREST-HCM: 93% of patients had ≥1 NYHA class improvement at 96 weeks; sustained hemodynamic benefits with low LVEF <50% (0.3% discontinuation).
- Integrated safety (463 patients, ~700 patient-years): aficamten well-tolerated, AE profile similar to placebo; new-onset AF 1.9% vs placebo 2%.
- FDA NDA under review; PDUFA target action date December 26, 2025.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0000950170-25-113599
- form_type
- 8-K/A
- ticker
- CYTK
- cik
- 0001061983
- company_name
- CYTOKINETICS INC
- filed_at
- 2025-09-08T23:59:59+00:00
- discovered_at
- 2026-05-14T18:02:43.228377+00:00
- generated_at
- 2026-05-17T07:28:02.740973+00:00
- sec_items
- ["8.01", "9.01"]
- event_type
- other_material
- sentiment
- positive
- materiality_score
- 0.75
- calibrated_materiality_score
- 0.75
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0000950170-25-113599
- json_url
- https://secwatch.observer/filing/0000950170-25-113599.json
- markdown_url
- https://secwatch.observer/filing/0000950170-25-113599.md
- text_url
- https://secwatch.observer/filing/0000950170-25-113599.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025113599/0000950170-25-113599-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025113599/cytk-20250831.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
- false
- correction_note
- null
- correction_timestamp
- null
- superseded_by
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