8-K
filed March 10, 2025, 7:59 PM ET
ticker CYTK
CIK 0001061983
regulatory
confidence high
sentiment positive
materiality 0.85
Cytokinetics: FDA won't hold adcom for aficamten NDA; Late Cycle meeting set for June 2025
CYTOKINETICS INC
- Cytokinetics completed midcycle review with FDA for aficamten NDA treating obstructive hypertrophic cardiomyopathy.
- FDA informed Cytokinetics it does not plan to convene an advisory committee meeting for the aficamten NDA.
- Late Cycle meeting with FDA expected in June 2025; company maintains expectation for differentiated label and risk mitigation if approved.
- Cytokinetics does not plan to share detailed updates on FDA communications beyond this update.
Machine-readable event card
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- secwatch.filing_event.v1
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- 0000950170-25-035914
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- CYTOKINETICS INC
- filed_at
- 2025-03-10T23:59:59+00:00
- discovered_at
- 2026-05-14T18:03:02.841036+00:00
- generated_at
- 2026-05-25T00:45:56.073560+00:00
- sec_items
- ["7.01"]
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- 0.85
- confidence
- high
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- https://secwatch.observer/filing/0000950170-25-035914.txt
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- https://www.sec.gov/Archives/edgar/data/1061983/000095017025035914/0000950170-25-035914-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025035914/cytk-20250310.htm
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- deepseek-v4-flash:cloud@v2
- review_status
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