axatilimab — Topline data
H2 2026
Topline data from the Phase 2 trial evaluating axatilimab in combination with ruxolitinib in patients with newly diagnosed chronic GVHD are anticipated in the second half of 2026.Source filing
INCY biotech catalysts & pipeline
INCYTE CORP · Data as of 2026-09-08
Upcoming catalysts
INCA033989 — Topline data
H2 2026
Data from the Phase 1 cohort evaluating INCA033989 as a monotherapy and in combination with ruxolitinib in treatment naïve MF patients are anticipated in the second half of 2026.Source filing
INCB160058 — Initial data
H2 2026
Data from the Phase 1 trial evaluating INCB160058 in patients with myeloproliferative neoplasms (MPNs) with a JAK2V617F mutation are anticipated in the second half of 2026.Source filing
Jakafi XR (ruxolitinib) — Regulatory decision
Q3 2026
We anticipate a regulatory decision from the European Commission in the third quarter of 2026.Source filing
Opzelura cream — Regulatory decision
Q3 2026
The Company expects a regulatory decision in the third quarter of 2026.Source filing
povorcitinib — Topline data
H2 2026
Topline data from the Phase 2 proof-of-concept trial for povorcitinib in asthma are anticipated in the second half of 2026.Source filing
ruxolitinib cream 1.5% — Regulatory decision
H2 2026
The Company expects a regulatory decision in the second half of 2026 following the submission of a Type-II variation application for ruxolitinib cream 1.5% for the treatment of adults with moderate AD in the EU.Source filing
povorcitinib — PDUFA
late-2026
The Company anticipates potential approval and launches in late-2026 in the European Union and the first quarter of 2027 in the U.S.Source filing
povorcitinib — Regulatory decision
late 2026
We submitted an MAA for povorcitinib to the EMA at the end of 2025 and we anticipate a potential approval in late 2026.Source filing
Jakafi XR (ruxolitinib) — Topline data
Q4 2026
Topline results from the Phase 3 studies (TRuE-HS1 and TRuE-HS2) evaluating ruxolitinib cream in mild to moderate hidradenitis suppurativa (HS) are anticipated in the fourth quarter of 2026.Source filing
povorcitinib — Topline data
Q4 2026
Data from the Phase 3 studies (STOP-PN1 and STOP-PN2) evaluating povorcitinib in patients with moderate to severe prurigo nodularis (PN) are anticipated in the fourth quarter of 2026.Source filing
INCA033989 — Initial data
2027
Phase 1 data evaluating INCA035784 in MF and ET patients with a CALR mutation are anticipated in 2027.Source filing
INCA035784 — Initial data
2027
Phase 1 data evaluating INCA035784 in MF and ET patients with a CALR mutation are anticipated in 2027.Source filing
Monjuvi/Minjuvi — PDUFA
Q1 2027
The Company anticipates a potential approval and launch in the U.S. in the first quarter of 2027.Source filing
povorcitinib — Regulatory decision
Q1 2027
The NDA submission for povorcitinib in HS was accepted by the FDA in the first quarter of 2026 and we anticipate a potential approval in the U.S. by the first quarter of 2027.Source filing
axatilimab — Initial data
early 2028
A Phase 3 trial evaluating axatilimab in combination with corticosteroids as an initial treatment in patients with chronic GVHD is ongoing, with results anticipated in early 2028.Source filing
latarcibart — Topline data
Early 2029
Topline data from the VIVID-6 study are anticipated in early 2029.Source filing
INCA33890 (TGFβR2xPD-1) — Conference presentation
Oct 23–Oct 27
Data from the ongoing Phase 1 trial evaluating INAC33890 in combination with standard-of-care therapies as a first-line treatment in patients with MSS CRC will be highlighted in a rapid oral presentation at the 2026 ESMO Congress.Source filing
INCB123667 — Conference presentation
Oct 23–Oct 27
Preliminary efficacy data from the ongoing Phase 1 trial evaluating INCB123667 in combination with bevacizumab in patients with recurrent epithelial ovarian cancer (rEOC) will be highlighted in a rapid oral presentation at the 2026 ESMO Congress.Source filing
INCB161734 (KRASG12D) — Conference presentation
Oct 23–Oct 27
Data from the ongoing Phase 1 trial evaluating INCB161734 in combination with standard-of-care chemotherapy (mFOLFOX and GemNabP) as a first-line treatment in patients with metastatic PDAC, as well as data evaluating INCB161734 in combination with cetuximab in patients with advanced/metastatic colorectal cancer (CRC), will be highlighted as rapid oral presentations at the 2026 European Society for Medical Oncology (ESMO) Congress, being held October 23–27 in Madrid, Spain.Source filing