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pdufa.bio

Aficamten

Updated ยทnext FDA decision on the calendar

Aficamten is a Cytokinetics Inc program in Non-obstructive hypertrophic cardiomyopathy. Its PDUFA date is Nov 14, 2026, the FDA's goal date to complete review of the application. Every date links its source.

CYTK catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Non-obstructive hypertrophic cardiomyopathy. Sponsor: Cytokinetics Inc (CYTK). Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Nov 14, 2026CYTK

Questions

When is Aficamten's next FDA decision or readout?

Aficamten's PDUFA date is Nov 14, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Aficamten's most recent FDA decision?

No FDA decision for Aficamten is in our archive yet.

What is Aficamten used for?

In our records Aficamten is under review or in development for Non-obstructive hypertrophic cardiomyopathy.

Who makes Aficamten?

Cytokinetics Inc (CYTK).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.