Incyte (INCY) Stock News

Incyte (INCY) announced that the FDA has extended the review period for ruxolitinib cream (Opzelura) for treating atopic dermatitis in children aged 2-11 years. The PDUFA date is pushed back by 3 months to September 19, 2025, allowing FDA to review additional CMC data for the 0.75% strength formulation. The sNDA submission was supported by Phase 3 TRuE-AD3 study results, which met its primary endpoint with significantly more patients achieving IGA-TS compared to vehicle control. The study also met its secondary endpoint with patients showing EASI75 improvement at Week 8. The safety profile remained consistent with previous data, showing only mild application site pain in 2.7% of treated patients, with no serious adverse events reported.

The FDA has approved Incyte's Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma (FL). This marks Monjuvi's second FDA approval, following its 2020 approval for DLBCL treatment. The Phase 3 inMIND trial demonstrated significant improvement in progression-free survival, with patients receiving Monjuvi achieving 22.4 months median PFS compared to 13.9 months in the control arm. The trial showed 27.5% of Monjuvi patients experienced events versus 47.6% in the control group. This approval represents the first FDA-approved CD19- and CD20-targeted immunotherapy combination for FL patients. The safety profile showed serious adverse reactions in 33% of patients, with respiratory tract infections and decreased neutrophils among the most common side effects.

QIAGEN (QGEN) and Incyte (INCY) have announced a global collaboration to develop a novel diagnostic panel for myeloproliferative neoplasms (MPNs). The partnership focuses on creating a multimodal panel using next-generation sequencing technology to detect gene alterations in blood cancers, particularly targeting mutant calreticulin (mutCALR). The panel will support Incyte's drug portfolio, including INCA033989, and will be validated on Illumina's NextSeq 550Dx platform. QIAGEN will handle regulatory submissions and market access across the US, EU, and Asia-Pacific regions. The collaboration aims to improve treatment decisions for MPN patients, which represent about 40% of hematological malignancies, by enabling precise identification of genomic aberrations in biomarkers like CALR.

Incyte announced groundbreaking clinical data for INCA033989, their first-in-class mutCALR-targeted monoclonal antibody therapy for essential thrombocythemia (ET). The late-breaking data presented at EHA2025 showed remarkable efficacy, with 86% of patients receiving doses ≥400mg achieving complete or partial hematologic response, and 82% reaching complete response. The drug demonstrated disease-modifying potential by selectively targeting and reducing mutCALR cells while promoting healthy blood cell production. In the study of 49 patients, 89% showed reduced mutCALR variant allele frequency. Safety profile was favorable with no dose-limiting toxicities, and 98% of patients maintained treatment. Most common side effects were mild, including fatigue (26.5%) and upper respiratory infections (20.4%). The company plans to initiate Phase 3 trials by early 2026 following regulatory discussions.

Incyte (INCY) announced the publication of Phase 3 POD1UM-303/InterAACT 2 trial results for Zynyz® (retifanlimab-dlwr) in The Lancet. The trial demonstrated significant benefits when combining retifanlimab with carboplatin-paclitaxel chemotherapy for treating advanced squamous cell carcinoma of the anal canal (SCAC). The study showed a 37% reduction in progression/death risk, with median progression-free survival of 9.3 months versus 7.4 months in the placebo group. Overall response rate improved to 55.8% with retifanlimab versus 44.2% with placebo. In May 2025, the FDA approved Zynyz® both in combination with chemotherapy for first-line treatment and as a single agent for advanced SCAC patients. Applications are under review by EMA and PMDA.

Specialised Therapeutics (ST) has expanded its partnership with Incyte to distribute two additional oncology therapies - axatilimab (Niktimvo) and retifanlimab (Zynyz) - in Australia, New Zealand, and Singapore. These medicines join the existing portfolio of Minjuvi and Pemazyre. Axatilimab, approved by FDA in August 2024, treats chronic graft-versus-host disease in patients who've had at least two prior treatments. Retifanlimab is approved for treating squamous cell carcinoma of the anal canal and Merkel cell carcinoma, with Australia having the highest MCC incidence globally. Under the agreement, Incyte will handle development and manufacturing, while ST will manage regulatory affairs, distribution, and local marketing. ST plans to submit both drugs for regulatory and reimbursement approval in 2025.

Incyte (INCY) has granted restricted stock unit awards (RSUs) totaling 16,550 shares to 19 new employees under its 2024 Inducement Stock Incentive Plan. The grants, effective June 2, 2025, were approved by the company's compensation committee as an inducement for new hires in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will vest over four years, with 25% of the shares vesting annually, contingent on continued employment with the company.

Incyte (INCY) announced multiple presentations at the 2025 European Hematology Association Congress in Milan, featuring late-breaking data for INCA033989, their novel mutCALR-directed monoclonal antibody for essential thrombocythemia (ET). The presentations include data from their hematology/oncology portfolio, with a key focus on INCA033989's potential as a disease-modifying treatment for myeloproliferative neoplasms. The congress will feature presentations on various programs including INCA035784, ruxolitinib, tafasitamab, axatilimab, INCB057643, and ponatinib. Incyte will host an analyst and investor event on June 15, 2025, from 6:00-7:30 a.m. EDT to discuss the mutCALR data.

Incyte (Nasdaq: INCY) has announced its upcoming participation at the Goldman Sachs Healthcare Conference. The presentation is scheduled for Monday, June 9, 2025 at 11:20 am ET. Investors and interested parties can access the live webcast through Investor.Incyte.com, with the replay remaining available for 30 days following the presentation.