Company Announcements

- 24-week data from the Phase 3 STOP-HS clinical trial program of povorcitinib in patients with hidradenitis suppurativa (HS) selected as a late-breaking oral presentation

WILMINGTON, Del.--(BUSINESS WIRE)--Sep. 10, 2025-- Today Incyte (Nasdaq:INCY) announced that it will present new data from its dermatology portfolio at the European Association of Dermatology and Venerology (EADV) 2025 Congress, held from September 17 – 20, in Paris. Highlights include late-breaking, oral and poster presentations featuring data for povorcitinib (INCB054707), an oral small-molecule JAK1 inhibitor, and ruxolitinib cream (Opzelura^®), a topical JAK1/2 inhibitor.

“Our presence at EADV demonstrates the significant progress across our dermatology portfolio. The late-breaking data from the STOP-HS clinical trial program reinforce the potential of povorcitinib to benefit patients impacted by hidradenitis suppurativa (HS), a challenging and debilitating immune-mediated dermatologic condition,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “Data on ruxolitinib cream in new patient populations continues to demonstrate safety and efficacy in individuals with atopic dermatitis (AD), vitiligo and prurigo nodularis (PN). We look forward to advancing these studies, and to providing additional treatment options for patients.”

Key abstracts from Incyte-sponsored programs include:

Late-Breaking Oral Presentations

Hidradenitis Suppurativa

Povorcitinib for Moderate to Severe Hidradenitis Suppurativa: Week 24 Interim Phase 3 Results
Presentation ID: D1T01.1C. Session Title: Late Breaking News. Presentation Time: 8:15 – 9:00 a.m. ET (2:15 – 3:00 p.m. CEST), September 17, 2025

Prurigo Nodularis

Efficacy and Safety of Ruxolitinib Cream in Patients With Prurigo Nodularis: Pooled Results From the Phase 3 TRuE-PN1 and TRuE-PN2 Randomized, Vehicle-Controlled Studies
Presentation ID: D1T01.2A. Session Title: Late Breaking News. Presentation Time: 10:00 - 10:15 a.m. ET (4:00 – 4:15 p.m. CEST), September 17, 2025

Oral Presentation

Vitiligo

Prevalence and Clinical Characteristics of Vitiligo-Associated Hearing Loss Among Patients Enrolled in a Phase 2 Clinical Trial of Povorcitinib
Presentation ID: FC03.1G. Session Title: Pigmentary Disorders. Presentation Time: 9:15 – 10:45 a.m. ET (3:15 – 4:45 p.m. CEST), September 18, 2025

Poster Presentations

Atopic Dermatitis

Ruxolitinib Cream Demonstrated Long-Term Disease Control with Time Off Treatment in Children with Atopic Dermatitis
Poster #3193

Vitiligo

Characterization of Vitiligo and Repigmentation Response by Lesion Extent and Distribution: Subgroup Analyses from the Ruxolitinib Cream Phase 2 TRuE-V Mechanism of Action Study
Poster #2741

An Open-Label, Phase 2, Safety and Efficacy Study of Ruxolitinib Cream in Patients With Genital Vitiligo
Poster #3236

Efficacy and Safety of Ruxolitinib Cream Combined With NB-UVB Phototherapy for Treatment of Vitiligo
Poster #2738

Multiple Indications

Long-Term Safety of Ruxolitinib Cream in Pediatric and Adult Patients: An Analysis of 7 Phase 3 Clinical Trials in Atopic Dermatitis and Nonsegmental Vitiligo
Poster #2653

More information regarding the 2025 EADV Congress can be found at: https://eadv.org/congress/scientific-programme/.

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

About Opzelura^® (ruxolitinib) Cream
Opzelura (ruxolitinib) cream, 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 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, the promise presented by that 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 our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-K for the quarter ended June 30, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

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Source: Incyte