8-K
filed September 2, 2025, 7:59 PM ET
ticker CYTK
CIK 0001061983
other material
confidence high
sentiment positive
materiality 0.85
Aficamten superior to metoprolol in MAPLE-HCM Phase 3 trial; primary endpoint met (p<0.0001)
CYTOKINETICS INC
- Least-squares mean pVO2 difference: +2.3 mL/kg/min (95% CI 1.5 to 3.1; p<0.0001) favoring aficamten.
- 51% of aficamten patients improved ≥1 NYHA class vs 26% on metoprolol (p<0.001).
- Aficamten reduced NT-proBNP by 81% vs metoprolol (p<0.0001); 1 patient had LVEF<50%.
- FDA PDUFA target action date for aficamten NDA is December 26, 2025.
- Results published simultaneously in The New England Journal of Medicine.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0000950170-25-112564
- form_type
- 8-K
- ticker
- CYTK
- cik
- 0001061983
- company_name
- CYTOKINETICS INC
- filed_at
- 2025-09-02T23:59:59+00:00
- discovered_at
- 2026-05-14T18:02:43.228874+00:00
- generated_at
- 2026-05-17T08:43:04.477698+00:00
- sec_items
- ["8.01", "9.01"]
- event_type
- other_material
- sentiment
- positive
- materiality_score
- 0.85
- calibrated_materiality_score
- 0.85
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0000950170-25-112564
- json_url
- https://secwatch.observer/filing/0000950170-25-112564.json
- markdown_url
- https://secwatch.observer/filing/0000950170-25-112564.md
- text_url
- https://secwatch.observer/filing/0000950170-25-112564.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025112564/0000950170-25-112564-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025112564/cytk-20250830.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
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- correction_note
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- correction_timestamp
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