- Featured abstracts for ruxolitinib cream (Opzelura®) include multiple presentations in atopic dermatitis and late-breaking data in prurigo nodularis (PN)

- Pipeline data presented includes data for axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD)

Incyte (Nasdaq: INCY) today announced that multiple abstracts featuring new data from its dermatology portfolio will be presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting, being held March 7–11, 2025, in Orlando.

"We look forward to sharing new data for ruxolitinib cream (Opzelura®) across multiple indications, including prurigo nodularis, and axatilimab (Niktimvo™) in patients with dermatologic manifestations of chronic graft-versus-host disease (GVHD) at this year's AAD Annual Meeting,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. "Incyte’s active participation in this key congress reinforces our commitment to addressing critical needs in dermatology while fostering meaningful dialogue with researchers, patients and advocates to inform the development of innovative treatments.”

Key abstracts include:

Late-Breaking Oral Presentation

Prurigo Nodularis (PN)

Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Results From a Phase 3, Randomized, Vehicle-Controlled Study (TRuE-PN1) (Session: S028 – Late-Breaking Research: Session 1. Saturday, March 8, 2025, 9:24 a.m. ET)

ePoster Exhibits

Atopic Dermatitis (AD)

Long-Term Safety of Ruxolitinib Cream in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Adverse Events of Interest from the TRuE-AD1 and TRuE-AD2 Phase 3 Studies ​(Abstract: #64524)

Association of Ruxolitinib Cream Initiation with Reduction in Use of Other Topical Treatments, Oral Corticosteroids, and Biologics for Atopic Dermatitis, Regardless of Previous Use of Biologics​ ​(Abstract: #64526)

52-Week Disease Control and Safety with As-Needed Application of Ruxolitinib Cream in Children Aged 2 to 11 Years with Moderate and/or More Extensive Atopic Dermatitis: Subgroup Analysis from the TRuE-AD3 Study ​(Abstract: #64656)

Ruxolitinib Cream Demonstrated Long-Term Disease Control and Quality of Life Benefits in Adults and Adolescents with Mild to Moderate Atopic Dermatitis ​​(Abstract: #64727)

Graft-Versus-Host Disease (GVHD)

Axatilimab for Patients with Dermatologic Manifestations of Chronic Graft-Versus-Host Disease: A Post Hoc Analysis ​(Abstract: #64616)

More information regarding the 2025 AAD Annual Meeting can be found at: https://www.aad.org/member/meetings-education/am25.

About Opzelura® (ruxolitinib) Cream 1.5% Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for repigmentation approved for use in the United States. Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Use of Opzelura in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants, such as azathioprine or cyclosporine, is not recommended.

In Europe, Opzelura (ruxolitinib) cream 15mg/g is approved for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

About Niktimvo™ (axatilimab-csfr) Niktimvo (axatilimab-csfr) is a first-in-class colony stimulating factor-1 receptor (CSF-1R)-blocking antibody approved for use in the U.S. for the treatment of chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs).

In 2016, Syndax licensed exclusive worldwide rights to develop and commercialize axatilimab from UCB. In September 2021, Syndax and Incyte entered into an exclusive worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications.

Axatilimab is being studied in frontline combination trials in chronic GVHD – a Phase 2 combination trial with ruxolitinib (NCT06388564) and a Phase 3 combination trial with steroids (NCT06585774) are underway. Axatilimab is also being studied in an ongoing Phase 2 trial in patients with idiopathic pulmonary fibrosis (NCT06132256).

Niktimvo is a trademark of Incyte.

All other trademarks are the property of their respective owners.

About Povorcitinib (INCB54707) Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 3 clinical trials for vitiligo, hidradenitis suppurativa (HS) and prurigo nodularis (PN), as well as Phase 2 trials for asthma and chronic spontaneous urticaria (CSU).

About Incyte A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte’s goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in Incyte’s reports filed with the Securities and Exchange Commission, including its annual report on form 10-K for the year ended December 31, 2024. Incyte disclaims any intent or obligation to update these forward-looking statements.

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