CYTK

aficamten

FDA PDUFA Target Action Date · CYTOKINETICS INC

Saturday, November 14, 2026

119 days away

Drug Information

Drug Name: aficamten (CT.gov)

Filing Details

Company: CYTOKINETICS INC →
Stock Ticker: CYTK
SEC CIK: 0001061983
Source: SEC 8-K Filing →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

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View CYTOKINETICS INC's full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-05-05. Report an issue