INCB160058

June 30, 2026: Incyte (NASDAQ: INCY) reported 2Q26 results and provided a pipeline/regulatory update, highlighting “ten clinical data readouts,” including four registrational trials, expected in 2H26. Key catalysts and milestones include:

• Opzelura (ruxolitinib) cream (inflammation/autoimmunity): EMA CHMP issued a positive opinion in June recommending approval for moderate atopic dermatitis in adults; an EMA regulatory decision is expected in 3Q26. Topline Phase 3 TRuE-HS1/TRuE-HS2 (hidradenitis suppurativa) results are anticipated in 4Q26. The company noted a CMS agreement on Medicaid rebate “line extension” rules, recording a one-time, non-cash $246M benefit in 2Q26 and estimating $300–$310M incremental 2026 Opzelura net sales impact.

• Povorcitinib: FDA accepted an NDA for moderate-to-severe HS in 1Q26; potential EU approval/launch is anticipated in late 2026 and U.S. in 1Q27. Phase 3 STOP-PN1/STOP-PN2 (prurigo nodularis) data are expected 4Q26; Phase 2 asthma topline data in 2H26.

• Monjuvi/Minjuvi (tafasitamab): frontMIND pivotal Phase 3 (1L DLBCL/HGBL) showed a statistically significant PFS improvement (primary endpoint); global regulatory submissions were submitted and accepted in 2Q26, with a potential U.S. approval/launch anticipated in 1Q27. Japan approved Minjuvi in June for R/R DLBCL + lenalidomide.

• Niktimvo (axatilimab-csfr): Phase 2 topline data for axatilimab + ruxolitinib in newly diagnosed chronic GVHD are anticipated in 2H26.

• INCA033989 (mutCALR): registrational Phase 3 EXCALIBUR-ET2 initiated mid-2026 (ET); additional Phase 1 MF data anticipated 2H26; a Phase 1 subcutaneous study started 2Q26. In July, Incyte signed a Halozyme collaboration to support subcutaneous formulation development using ENHANZE technology.

• Latarcibart (formerly VGA039; VWD): Phase 1/2 data presented July at ISTH showed an 81% median reduction in annualized bleeding rate with once-monthly SC dosing; Phase 3 VIVID-6 topline is anticipated early 2029. In July, Incyte completed its acquisition of Vega Therapeutics for $1.25B upfront plus up to $750M sales milestones.

• Oncology pipeline: INCB161734 (KRASG12D; PDAC/CRC) and INCA33890 (TGFβR2xPD-1; MSS CRC) Phase 3 programs are ongoing; Phase 1 combination data for both are slated for rapid oral presentations at ESMO 2026 (Oct 23–27). INCB123667 (CDK2) Phase 3 maintenance ovarian cancer study is expected to initiate in 2H26; Phase 1 rEOC combo data will also be presented at ESMO 2026.

• Other: INCB160058 (JAK2V617F) development was discontinued. In 2Q26, Incyte licensed zilurgisertib (ALK2 inhibitor; FOP) to Mirum (upfront plus milestones and mid-to-high single-digit royalties).