Incyte Reports Strong Q2 2025 Results with Jakafi Growth and New Drug Approvals
Key Insights
Incyte reported strong second quarter 2025 financial results with Jakafi net revenues of $764 million, representing 8% year-over-year growth driven by increased demand across all indications.
The company achieved two significant regulatory milestones with FDA approvals of Zynyz for squamous cell anal carcinoma and Monjuvi for follicular lymphoma (search), expanding treatment options for cancer patients.
Niktimvo, launched in Q1 2025, demonstrated continued strong commercial uptake with $13.6 million in sales, while Opzelura revenues grew 35% to $164 million driven by increased patient demand in both atopic dermatitis (search) and vitiligo (search).
Incyte Corporation reported robust second quarter 2025 financial results, with total net product revenues increasing 17% year-over-year, driven by strong performance across its key therapeutic portfolio and recent regulatory approvals that expand treatment options for cancer patients.
The biopharmaceutical company's flagship product Jakafi (ruxolitinib) generated net revenues of $764 million in the second quarter, representing 8% growth compared to the same period in 2024. This growth was driven by an 8% increase in paid demand reflecting continued demand growth across all approved indications, including polycythemia vera (search), myelofibrosis (search), and graft-versus-host disease (search).
Regulatory Milestones Expand Treatment Portfolio
Incyte achieved two significant regulatory milestones during the quarter that strengthen its oncology portfolio. In May 2025, the FDA approved Zynyz (retifanlimab-dlwr (search)) in combination with chemotherapy and as a single agent for treating adult patients with advanced squamous cell carcinoma (search) of the anal canal. The Priority Review and FDA approval were based on data from the Phase 3 POD1UM-303/InterAACT2 trial and the Phase 2 POD1UM-202 trial.
Additionally, the FDA approved Monjuvi (tafasitamab-cxix) in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma (search), a type of slow-growing blood cancer. This approval was based on data from the pivotal Phase 3 inMIND trial and received Priority Review designation.
Strong Commercial Performance Across Key Products
Opzelura (ruxolitinib cream) demonstrated exceptional growth with net revenues of $164 million in the second quarter, representing a 35% increase year-over-year. U.S. revenues reached $132 million, growing 19% compared to the second quarter of 2024, driven by increased patient demand and refills in both atopic dermatitis (search) and vitiligo (search) indications. International revenues contributed $32 million, primarily from continued growth in France and recent launches in Italy and Spain.
Niktimvo (axatilimab-csfr), Incyte's first-in-class CSF-1R (search)-blocking antibody launched in the first quarter of 2025, recorded $13.6 million in sales during the quarter. The drug is approved for treating chronic graft-versus-host disease (search) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
Pipeline Advances Show Promise for Disease Modification
The company reported significant progress in its clinical development programs, particularly with INCA033989 for myeloproliferative neoplasms. Data presented at the 2025 European Hematology Association Congress showed that INCA033989 achieved rapid and durable normalization of platelet counts across all dose levels in patients with essential thrombocythemia (search). Importantly, the treatment demonstrated a reduction in peripheral blood mutCALR (search) variant allele frequency correlating with hematologic response, suggesting potential for disease modification by directly inhibiting and eliminating oncogenic mutCALR cells while sparing healthy cells.
"The data demonstrates the potential of INCA033989 for disease modification by directly inhibiting and eliminating oncogenic mutCALR (search) cells, while sparing healthy cells and restoring normal blood cell production," the company stated. Phase 1 data in patients with myelofibrosis (search) as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025.
Financial Outlook and Guidance Updates
Incyte raised its 2025 revenue guidance for Jakafi to account for higher demand in the first half of the year and increased guidance for other oncology products to reflect the strength of the Niktimvo launch and higher demand for Zynyz. The company also updated its cost of product revenues guidance to reflect the reduction in the Jakafi royalty rate payable to Novartis following a contract dispute settlement.
As of June 30, 2025, the company maintained a strong financial position with cash, cash equivalents, and marketable securities totaling $2.4 billion, compared to $2.2 billion at the end of 2024.
Expanding Development Programs
The company continues to advance multiple late-stage development programs across its inflammation and autoimmunity portfolio. In April 2025, Incyte announced positive topline results from the Phase 3 TRuE-AD4 study evaluating ruxolitinib cream in adult patients with moderate atopic dermatitis (search), meeting both co-primary endpoints and all key secondary endpoints.
Two Phase 3 studies evaluating povorcitinib versus placebo in patients with vitiligo (search) (STOP-V1 and STOP-V2) are ongoing, with data anticipated in 2026. Similarly, two Phase 3 studies in prurigo nodularis (search) (STOP-PN1 and STOP-PN2) are progressing, with results expected in 2026.
"As I begin my tenure as CEO, I look forward to leading Incyte through its next phase of growth and value creation for patients, partners and shareholders," said Bill Meury, Chief Executive Officer. "Our second quarter results reflect strong growth for Jakafi, Opzelura and Niktimvo, positioning us well to deliver on our 2025 objectives."