• Two late-breaking abstracts have been accepted for oral presentation, including randomized studies evaluating ruxolitinib cream (Opzelura^®) in hidradenitis suppurativa and povorcitinib (INCB54707) in prurigo nodularis
• Analyst and investor event to discuss key data presentations scheduled for Monday, March 11, 2024 at 9:00 a.m. PT / 12:00 p.m. ET

Incyte (Nasdaq:INCY) today announced multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming 2024 American Academy of Dermatology (AAD) Annual Meeting, held March 8-12, 2024, in San Diego.

“We are pleased to convene at this year’s AAD Annual Meeting and share data, including two late-breaking presentations, from our growing dermatology portfolio,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “Our presence at this year’s meeting showcases Incyte’s commitment to find solutions for patients where there continues to be critical unmet needs. We are excited to share clinical data evaluating ruxolitinib cream and povorcitinib in immune-mediated dermatologic conditions including atopic dermatitis, vitiligo, hidradenitis suppurativa and prurigo nodularis.”

Key abstracts include:

Late-Breaking Oral Presentations

Prurigo Nodularis

Efficacy and Safety of Povorcitinib in Patients with Prurigo Nodularis: Results From a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study (Session: S050 – Late-Breaking Research: Session 2. Sunday, March 10, 2024, 4:00 p.m. ET)

Hidradenitis Suppurativa

Efficacy and Safety of Ruxolitinib Cream in Patients With Hidradenitis Suppurativa (Hurley Stage I and II): Results From a Randomized, Double-Blind, Vehicle-Controlled Phase 2 Study (Session: S050 – Late-Breaking Research: Session 2. Sunday, March 10, 2024, 4:10 p.m. ET)

e-Posters with Mini Oral Presentation

Atopic Dermatitis

Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Previous Medication History: Subgroup Analysis from the Randomized Phase 3 TRuE-AD3 Study (Abstract: #54214. Friday, March 8, 2024, 4:10 – 4:15 p.m. ET. Upper Level, Sails Pavilion, Poster Center 2)

e-Poster Exhibits

Atopic Dermatitis

Effect of Ruxolitinib Cream on Patient-Reported Outcomes (PROs) in Children Aged 2–<12 Years with Atopic Dermatitis (AD): Results from a Randomized, Double-Blind, Vehicle-Controlled, Phase 3 Study (TruE-AD3) (Abstract: #49439)

Atopic Dermatitis (AD) Treatments Before and After Initiation of Ruxolitinib Cream: Analysis of a US Payer Claims Database (Abstract: #53102)

Real-World Clinical Experience with Ruxolitinib Cream Monotherapy to Manage Atopic Dermatitis (Abstract: #53107)

A Maximum-Use Trial of Ruxolitinib Cream in Children ≥2 to <12 Years Old with Atopic Dermatitis (AD): Patient-Reported Outcomes (PROs) at Week 8 (Abstract: #54025)

Efficacy of Ruxolitinib Cream for Treatment of Atopic Dermatitis in Children Aged 2–<12 Years by Baseline Clinical Characteristics: Subgroup Analysis from a Randomized Phase 3 Study (TRuE-AD3) (Abstract: #54147)

Maximum-Use Trials of Ruxolitinib Cream in Adults, Adolescents, and Children Aged 2 to <12 Years with Atopic Dermatitis: Consistency of Safety, Pharmacokinetics, and Efficacy (Abstract: #54168)

Vitiligo

Serum Protein Biomarkers May Reveal Clues to Early Immune Activity Upon Ruxolitinib Cream Withdrawal in the TRuE-V Long-Term Extension Study (Abstract: #50342)

Efficacy of Povorcitinib for the Treatment of Vitiligo by Patient Demographics and Baseline Clinical Characteristics: Week 52 Subgroup Analysis from a Randomized, Placebo-Controlled, Phase 2b Clinical Trial (Abstract: #53962)

Correlation of Vitiligo Area Scoring Index with Vitiligo Extent Score-Plus Responses in a Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Phase 2b Study (Abstract: #53971)

All abstract content will be available in the online viewing portal and on-site at the viewing stations. They will also be published online via the Journal of the American Academy of Dermatology (JAAD) supplement in Fall 2024.

More information regarding the 2024 AAD Annual Meeting can be found at https://www.aad.org/member/meetings-education/am24.

Conference Call and Webcast

Incyte will host an in-person analyst and investor event on Monday, March 11, 2024, from 9:00-10:30 a.m. PT (12:00-1:30 p.m. ET) to discuss the key data presentations at AAD. The event will be webcasted and can be accessed via the Events and Presentations tab of the investor section of Incyte.com and it will be available for replay for 30 days.

Conference call details will be provided on our website.

About Opzelura^® (ruxolitinib) Cream 1.5%

Opzelura, a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is 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 and Europe as Opzelura.

Opzelura and the Opzelura logo are registered trademarks of Incyte.

About Povorcitinib (INCB54707)

Povorcitinib (INCB54707) is an oral small-molecule JAK1 inhibitor currently in Phase 2 clinical trials for vitiligo, hidradenitis suppurativa (HS) and prurigo nodularis. Phase 3 studies in HS are also ongoing.

About Incyte Dermatology

Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. Today, we are building on this legacy as we discover and develop innovative dermatology treatments to bring solutions to patients in need.

Our research and development efforts in dermatology are initially focused on leveraging our knowledge of the JAK-STAT pathway. We are exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo, hidradenitis suppurativa, lichen planus, lichen sclerosus and prurigo nodularis.

To learn more, visit the Dermatology section of Incyte.com.

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.

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 for the year ended December 31, 2023. Incyte disclaims any intent or obligation to update these forward-looking statements.

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