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

CYTOKINETICS INC

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.

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