Incyte Corporation (INCY) reports developments for a biopharmaceutical business focused on hematology, oncology, and inflammation and autoimmunity. Recurring updates cover commercial medicines such as Jakafi, Jakafi XR, and Opzelura, regulatory decisions for approved and investigational therapies, and clinical data across blood cancers, graft-versus-host disease, dermatology, and solid tumors.
Company news also includes financial results, product revenue trends, pipeline progress, investor conference participation, executive appointments, equity inducement awards, and international regulatory updates tied to hematology and oncology therapies.
Incyte (Nasdaq: INCY) announced European Commission approval of Zynyz (retifanlimab) plus carboplatin and paclitaxel for first-line treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC).
The decision follows a CHMP positive opinion and Phase 3 POD1UM-303 results showing a 37% reduction in risk of progression or death (P=0.0006) and median PFS of 9.3 vs 7.4 months. No new safety signals were identified; serious adverse reactions occurred in 47% of combination patients.
Eli Lilly (NYSE: LLY) announced a positive CHMP opinion recommending Olumiant (baricitinib) for adolescents ages 12 to <18 with severe alopecia areata. The recommendation is based on Phase 3 BRAVE-AA-PEDS results showing 42.4% achieved ≥80% scalp hair coverage at 36 weeks (4 mg).
The opinion moves to the European Commission for final action, expected in one to two months; a U.S. decision is expected in the second half of 2026.
Incyte (Nasdaq: INCY) will present at three investor conferences in early March 2026: TD Cowen on March 2 at 10:30 am EST, Leerink Partners on March 10 at 9:20 am EDT, and Barclays on March 11 at 8:30 am EDT.
Each presentation will be webcast live at Investor.Incyte.com and replays will be available for 30 days.
Incyte (Nasdaq:INCY) reported Q4 2025 total revenue $1.51B (+28% Y/Y) and FY2025 total revenue $5.14B (+21% Y/Y). FY2025 total net product revenue was $4.35B (+20%), above guidance. Cash and marketable securities rose to $3.6B. Company provided FY2026 net product revenue guidance of $4.77–$4.94B and GAAP R&D+SG&A expense guidance of $3.495–$3.675B.
Incyte (Nasdaq:INCY) announced a positive CHMP opinion recommending approval of Zynyz (retifanlimab) plus carboplatin and paclitaxel for first-line treatment of adult metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC) in Europe, pending European Commission decision.
Phase 3 POD1UM-303/InterAACT2 showed a 37% reduction in risk of progression or death (P=0.0006); median PFS 9.3 vs 7.4 months. No new safety signals; serious adverse reactions occurred in 47% of patients.
Incyte (Nasdaq:INCY) scheduled its fourth quarter and year-end 2025 financial results release and conference call for Tuesday, February 10, 2026. The press release will be issued at 7:00 a.m. ET, followed by a conference call and webcast with slides at 8:00 a.m. ET.
Domestic dial-in: 877-407-3042. International dial-in: 201-389-0864. Conference ID: 13758313. A replay of the call will be available for 30 days (U.S. replay 877-660-6853; international 201-612-7415). The live webcast and slides will be accessible at Investor.Incyte.com and available for replay for 90 days.
Incyte (NASDAQ:INCY) reported positive topline results from the pivotal Phase 3 frontMIND trial of tafasitamab (Monjuvi/Minjuvi) plus lenalidomide with R-CHOP versus R-CHOP alone as first-line treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL).
The trial met its primary endpoint of progression-free survival (PFS) by investigator assessment (Hazard Ratio 0.75 [0.59,0.96]; p=0.019) and met the key secondary endpoint of event-free survival (EFS). No new safety signals were observed. Incyte plans to file a sBLA in H1 2026 and will submit frontMIND data for presentation at an upcoming scientific meeting.
Incyte (NASDAQ:INCY) announced Japan MHLW approval of Minjuvi (tafasitamab) in combination with rituximab and lenalidomide for adult patients with relapsed or refractory follicular lymphoma (2L+ FL) on December 22, 2025.
The approval is based on the Phase 3 inMIND trial (654 patients) where the Minjuvi combination achieved a median progression-free survival (PFS) of 22.4 months vs 13.9 months for control, hazard ratio 0.43 (p<0.0001). Independent Review Committee assessments showed median PFS not reached in the Minjuvi arm versus 16.0 months in placebo. Common adverse reactions included respiratory infections, diarrhea and fatigue. This is Minjuvi's first regulatory approval in Japan.
Incyte (NASDAQ: INCY) announced that Japan Ministry of Health, Labour and Welfare approved Zynyz® (retifanlimab) plus carboplatin and paclitaxel for first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC) on December 22, 2025.
The approval is based on Phase 3 POD1UM-303/InterAACT2 results showing a 37% reduction in risk of progression or death (P=0.0006) and median progression-free survival of 9.3 months vs 7.4 months for placebo plus chemotherapy. No new safety concerns were identified; serious adverse reactions occurred in 47% of patients receiving Zynyz combination. This is Zynyz’s first approval in Japan and follows the FDA approval in May 2025; an EMA Type II variation MAA is pending for advanced SCAC.
Incyte (Nasdaq:INCY) will present at the 44th Annual J. P. Morgan Healthcare Conference on Monday, January 12, 2026 at 8:15 AM PST. The presentation will be webcast live at Investor.Incyte.com and the webcast replay will be available for 30 days.