---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-204991"
form_type: "8-K"
ticker: "CYTK"
cik: "0001061983"
company_name: "CYTOKINETICS INC"
filed_at: "2025-09-16T23:59:59+00:00"
generated_at: "2026-05-17T06:26:31.217363+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Cytokinetics provides FDA/EMA update on aficamten; plans to draw $100M Royalty Pharma loan

## Summary
- FDA Late Cycle Meeting held; discussed REMS and label for aficamten in oHCM; PDUFA date remains Dec 26, 2025.
- GCP inspections completed with no observations; no GMP inspections scheduled for aficamten.
- Submitted responses to CHMP Day 120 questions from EMA for aficamten potential EU approval.
- Intends to draw full $100M Tranche 5 term loans from Royalty Pharma on or about October 1, 2025.

## SEC filing metadata
- accession: 0001193125-25-204991
- form_type: 8-K
- ticker: CYTK
- cik: 0001061983
- company_name: CYTOKINETICS INC
- filed_at: 2025-09-16T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1061983/000119312525204991/0001193125-25-204991-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1061983/000119312525204991/d66361d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-204991
- JSON: https://secwatch.observer/filing/0001193125-25-204991.json
- Plain text: https://secwatch.observer/filing/0001193125-25-204991.txt

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