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Jakafi XR (ruxolitinib)

Updated ยทnext FDA decision on the calendar

Jakafi XR (ruxolitinib) 1 FDA decision on record below. Every date links its source.

INCY catalyst hub

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 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 · May 1, 2026 ✓ ApprovedINCY

Questions

When is Jakafi XR (ruxolitinib)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Jakafi XR (ruxolitinib); 1 FDA decision is on record below.

What happened at Jakafi XR (ruxolitinib)'s most recent FDA decision?

On May 1, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.