INCY · 10-Q · 2026Q3 · Full report

JAKAFI XR Product Launch

INCYTE CORP · 2026-10-29 · Importance 35 · Surprise 42

In May 2026, the FDA approved JAKAFI XR, an extended-release ruxolitinib tablet. It is indicated for adults with intermediate- or high-risk myelofibrosis and adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Its indications also include acute and chronic graft-versus-host disease in adults and children aged 12 years and older.

Key facts

• The FDA approved JAKAFI XR in May 2026 for adults with intermediate- or high-risk MF, adults with PV with inadequate response or intolerance to hydroxyurea, and patients aged 12 years or older with steroid-refractory acute GVHD or chronic GVHD after failure of one or two systemic therapy lines. source