Incyte (INCY) Stock News

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.

Incyte (NASDAQ:INCY) announced European Commission approval of Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma (Grade 1-3a) after ≥1 systemic therapy.

The approval follows a positive CHMP opinion and is supported by Phase 3 inMIND results: investigator-assessed median progression-free survival (PFS) 22.4 months versus 13.9 months (HR 0.43; P<0.0001); IRC-assessed PFS not reached versus 16.0 months (HR 0.41). Safety was described as generally well-tolerated; common adverse reactions (≥20%) included respiratory infections, diarrhea, rash, fatigue, constipation, musculoskeletal pain and cough.

Incyte (Nasdaq: INCY) announced that Hervé Hoppenot has resigned from the company's Board of Directors, effective immediately on December 12, 2025.

Mr. Hoppenot had been serving as an advisor to the CEO and as a board member during a planned transition period. He joined Incyte in 2014 and previously served as chairman and CEO. Julian Baker, Incyte's chairman, thanked Mr. Hoppenot for his leadership and said he left a lasting impact on the company’s work delivering transformative science and medicines for patients.

Incyte (Nasdaq:INCY) reported updated Phase 1 data (data cut-off Sep 25, 2025) for INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody, in essential thrombocythemia (ET) patients resistant/intolerant to prior cytoreductive therapy.

At higher doses (400–2,500 mg) 90% achieved a hematologic response and 83.3% achieved complete hematologic response (CHR); 46.4% achieved durable (≥12 weeks) CHR. A mutCALR VAF reduction occurred in 96.2% of patients with post‑baseline measurements; 52% had ≥25% VAF reduction and 31% had ≥50% reduction. No dose‑limiting toxicities were observed and the FDA granted Breakthrough Therapy designation for Type 1 CALR ET.

Incyte (NASDAQ:INCY) reported Phase 1 data for INCA033989, a mutCALR-targeted monoclonal antibody, showing rapid spleen-volume and symptom reductions and anemia improvements in myelofibrosis (data cut-off Sept 25, 2025). As monotherapy (n=36 evaluable at Week 24) SVR25 was 41.7% and SVR35 33.3%; higher responses were seen in JAK‑naïve patients. Anemia response occurred in 56% (14/25) with 40% major responses. Most patients showed reductions in mutCALR VAF and bone marrow mutCALR+ progenitors. No dose‑limiting toxicities; MTD not reached. Registrational program planned for 2026.

Incyte (Nasdaq:INCY) announced the U.S. FDA granted Breakthrough Therapy designation to INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody, for treatment of essential thrombocythemia (ET) patients with a Type 1 CALR mutation who are resistant or intolerant to at least one cytoreductive therapy.

The designation was supported by early Phase 1 data showing INCA033989 was well‑tolerated and produced rapid, durable platelet normalization; updated Phase 1 data and new myelofibrosis results will be presented at ASH 2025 on December 8. Incyte plans to seek regulator alignment and begin a Phase 3 program in mid‑2026 to evaluate patients with all CALR mutation types.

Key context: CALR mutations occur in ~25% of ET patients and Type 1 deletions represent ~55% of CALR mutations.