DE-INCYTE
18.3.2022 14:58:06 CET | Business Wire | Press release
Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its dermatology portfolio will be presented at the upcoming American Academy of Dermatology (AAD) Annual Meeting, held March 25-29, 2022, in Boston.
New 52-week data from the Phase 3 TRuE-V vitiligo program evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo will be presented as an oral presentation in a late-breaking abstract session. Incyte previously announced positive 24-week results from the TRuE-V1 and TRuE-V2 studies.
“We are pleased to convene again at AAD 2022 and present new ruxolitinib cream data which highlights its potential for patients with atopic dermatitis and vitiligo and our commitment to the Dermatology community,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “We look forward to sharing data from multiple Phase 3 studies highlighting clinical trial data for ruxolitinib cream – notably the 52-week results from the TRuE-V vitiligo program – as well as findings from the VALIANT study which contribute to the scientific understanding of the natural history of vitiligo and its burden on patients in the United States.”
Key abstracts include:
Late-Breaking Oral Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream Monotherapy for the Treatment of Vitiligo: Results from Two 52-Week Phase 3 Studies (Session: S026 – Late-Breaking Research: Clinical Trials. Saturday, March 26, 10:40 a.m. ET)
Posters with Oral Presentation
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Anatomic Region: Pooled Analysis From Two Randomized Phase 3 Studies (Category: Atopic Dermatitis)
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: Week 24 Pooled Analysis of the TRuE-V Phase 3 Studies (Category: Pigmentary Disorders & Vitiligo)
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo by Patient Demographics and Baseline Clinical Characteristics: Pooled Subgroup Analysis From Two Randomized Phase 3 Studies (Category: Pigmentary Disorders & Vitiligo)
The Mental Health and Psychosocial Burden Among Patients Living With Vitiligo in the United States: Findings From the VALIANT Study (Category: Pigmentary Disorders & Vitiligo)
Poster Presentations
Atopic Dermatitis
Long-Term Safety and Disease Control of Ruxolitinib Cream Among Black or African American Patients With Atopic Dermatitis: Pooled Results From Two Phase 3 Studies (Abstract #34794. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Ruxolitinib Cream Provided Progressive Improvement in Patients With Atopic Dermatitis Who Did Not Achieve Investigator’s Global Assessment Treatment Success at Week 8: Pooled Results From Two Phase 3 Studies (Abstract #35163. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Vitiligo
Exploring the Natural History of Vitiligo in the United States: Findings From the VALIANT Study (Abstract #34612. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Do Patients With Vitiligo and Healthcare Professionals Treating Them Recognize the Burden in Living With the Disease in the United States? Findings From the VALIANT Study (Abstract #34631. Friday, March 25, 2022 - Sunday, March 27, 2022, 9:00 a.m. – 5:00 p.m. ET; ePoster only)
Full abstracts will be available on the AAD website on March 25, 2022. More information regarding the 2022 AAD Annual Meeting can be found at https://www.aad.org/member/meetings-education/am22.
About Ruxolitinib Cream (Opzelura™)
Ruxolitinib cream (Opzelura) a novel cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, is the first and only topical JAK inhibitor approved for use in the United States 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 October 2021, Incyte announced the validation of the European Marketing Authorization Application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age >12 years) with non-segmental vitiligo with facial involvement. Additionally, in December 2021, Incyte announced the acceptance and priority review of the supplemental New Drug Application (sNDA) for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with vitiligo.
Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.
Opzelura is a trademark of Incyte.
About Incyte Dermatology
Incyte’s science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company’s research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.
Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com .
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte .
Forward-Looking Statements
Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the potential of Opzelura to provide a successful treatment for atopic dermatitis, whether and when ruxolitinib cream might be approved to treat patients with vitiligo, the potential for success of such treatment, Incyte’s clinical trials and Incyte’s Dermatology program generally, contain predictions, estimates and other forward-looking statements.
These forward-looking statements are based on the Company’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; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company’s clinical trials, supply chain, other third-party providers and development and discovery operations; determinations made by the FDA and other regulatory authorities; the efficacy or safety of the Company’s products; the acceptance of the Company’s products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission, including its annual report and its quarterly report on Form 10-Q for the quarter ended December 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220318005248/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Mary Kay Extends Winning Streak With Fourth Year as #1 in Global Direct Selling Beauty23.6.2026 14:03:00 CEST | Press release
Euromonitor International Recognizes Mary Kay’s Sustained Leadership In Skin Care And Color Cosmetics Mary Kay Inc., the iconic beauty and entrepreneurship company, has once again been named the #1 Direct Selling Brand of Skin Care and Color Cosmetics in the World1 by Euromonitor International, sustaining its legacy of excellence for the fourth consecutive year. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623487381/en/ Mary Kay Inc., the iconic beauty and entrepreneurship company, for the fourth year in a row has been named the #1 Direct Selling Brand of Skin Care and Color Cosmetics in the World by Euromonitor International. (Image Credit: Mary Kay Inc.) “Earning the #1 global ranking from Euromonitor for the fourth consecutive year comes as a powerful endorsement of the impact of our Independent Beauty Consultants around the world who drive our success every day,” said Ryan Rogers, Chief Executive Officer of Mary Kay
Kobie 2026 Heart of Loyalty Report Reveals Growing Gap Between Consumer Expectations and Brand Loyalty Strategies23.6.2026 14:00:00 CEST | Press release
Global study finds consumers are more ready for AI, more willing to share data, and more motivated by recognition and shared values than many brands realize Kobie, a global leader in loyalty technology and services, today released its 2026 Heart of Loyalty Report, which surveyed both consumers and practitioners, revealing significant gaps between consumer expectations and brand loyalty strategies across AI adoption, data sharing, recognition, advocacy, and community engagement. Kobie's 2026 Heart of Loyalty Report found that: 57% of consumers are willing to engage with AI-powered brand experiences, yet 56% of loyalty practitioners believe customers are not ready for AI. 77% of consumers want recognition from brands, but only 55% feel seen as individuals. 72% of consumers say they would refer a brand without an incentive, yet many referral strategies remain heavily dependent on rewards. Rewards are the strongest driver of willingness to share personal data, yet only 65% of practitioners
Veristat Strengthens Biostatistics, Drug Development Advisory, and People Leadership to Support Growth in Complex Clinical Development23.6.2026 13:05:00 CEST | Press release
Dr. Zhaohui Su and Dr. Gil Fine deepen Veristat’s biostatistics expertise, Scott Tarrant leads Strategic Drug Development Advisory, and Clint Wolfe joins as Chief Human Resources Officer VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, today announced four strategic leadership hires that advance its mission to accelerate novel therapy approvals in complex disease areas, including cell and gene therapy, oncology, and rare disease. Building on its 30-year foundation in biostatistics and its recent acquisition of the medical writing and regulatory submission business of Certara, Veristat is deepening its scientific expertise and expanding its operational leadership to meet growing client demand. Dr. Zhaohui Su and Dr. Gil Fine join Veristat’s Strategic Drug Development Advisory team in biostatistical leadership roles, collaborating with Scott Tarrant, who has been named Executive Vice President of the team. In addition, Clint Wolfe
Bacardi Takes Full Ownership of TEELING® Irish Whiskey23.6.2026 13:00:00 CEST | Press release
Irish whiskey brand joins family-owned company’s portfolio of premium brands Bacardi Limited has announced the completion of a transaction that makes the family-owned company the sole owner of the Teeling Whiskey Company and the TEELING® Irish whiskey brand. Founders Jack and Stephen Teeling will remain a part of the brand, shaping its future and driving growth for the long term as strategic advisors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623858211/en/ Three expressions of Teeling Irish Whiskey: Single Grain, Small Batch and Single Malt Today’s announcement follows the successful relationship the two companies have enjoyed since Bacardi acquired a minority stake in the Dublin-based whiskey company in 2017. Bacardi subsequently increased its stake to become the majority shareholder in 2022. “TEELING is the perfect fit for Bacardi,” says Mahesh Madhavan, Chief Executive Officer, Bacardi Limited. “The brand stands f
Bending Spoons S.p.A. announces launch of initial public offering23.6.2026 12:15:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the launch of its initial public offering (the “IPO”) of its ordinary shares. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 are being offered by Bending Spoons and 23,572,375 are being offered by certain selling shareholders (the “Selling Shareholders”). In connection with the offering, Bending Spoons and the Selling Shareholders have granted the underwriters a 30-day option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and an additional 3,451,626 ordinary shares from the Selling Shareholders at the IPO price, less underwriting discounts and commissions. The IPO price is currently estimated to be between $26.00 and $28.00 per share. Bending Spoons has applied to list its ordinary shares on the Nasdaq Global Select Market under the ticker symbol “BSP.” Goldman Sachs International, J.P. Morgan, and Allen & Company LLC are acting as joint l
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom