8-K
filed May 1, 2025, 7:59 PM ET
ticker CYTK
CIK 0001061983
regulatory
confidence high
sentiment neutral
materiality 0.50
Cytokinetics announces FDA extends aficamten PDUFA date to Dec 26, 2025 on REMS review
CYTOKINETICS INC
- FDA extended PDUFA date for aficamten NDA in oHCM to December 26, 2025, a three-month extension.
- Extension due to FDA requesting a Risk Evaluation and Mitigation Strategy (REMS) as a Major Amendment.
- No additional clinical data or studies requested; NDA originally filed without REMS.
- Cytokinetics submitted the REMS after FDA request; review continues.
Machine-readable event card
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- secwatch.filing_event.v1
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- 0000950170-25-061847
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- 0001061983
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- CYTOKINETICS INC
- filed_at
- 2025-05-01T23:59:59+00:00
- discovered_at
- 2026-05-14T18:02:47.374096+00:00
- generated_at
- 2026-05-22T23:41:35.438946+00:00
- sec_items
- ["8.01"]
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- regulatory
- sentiment
- neutral
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- 0.5
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- 0.5
- confidence
- high
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- https://secwatch.observer/filing/0000950170-25-061847
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- https://secwatch.observer/filing/0000950170-25-061847.json
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- https://secwatch.observer/filing/0000950170-25-061847.md
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- https://secwatch.observer/filing/0000950170-25-061847.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025061847/0000950170-25-061847-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1061983/000095017025061847/cytk-20250429.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
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