---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-061847"
form_type: "8-K"
ticker: "CYTK"
cik: "0001061983"
company_name: "CYTOKINETICS INC"
filed_at: "2025-05-01T23:59:59+00:00"
generated_at: "2026-05-22T23:41:35.438946+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# Cytokinetics announces FDA extends aficamten PDUFA date to Dec 26, 2025 on REMS review

## Summary
- 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.

## SEC filing metadata
- accession: 0000950170-25-061847
- form_type: 8-K
- ticker: CYTK
- cik: 0001061983
- company_name: CYTOKINETICS INC
- filed_at: 2025-05-01T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1061983/000095017025061847/0000950170-25-061847-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1061983/000095017025061847/cytk-20250429.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-061847
- JSON: https://secwatch.observer/filing/0000950170-25-061847.json
- Plain text: https://secwatch.observer/filing/0000950170-25-061847.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.