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
From Cutting-Edge Research to Industry: Focused Energy Plans Spin-Off of Sourcelight10.6.2026 11:38:00 CEST | Press release
Following its successful USD 240 million financing round, Focused Energy is continuing to systematically advance the industrialization of laser fusion as its core business. At the same time, the company plans to consolidate its activities in the field of laser-driven radiation sources into an independent entity under the name Sourcelight. With this move, Focused Energy is laying the groundwork for the industrial transfer of selected technological building blocks emerging from its laser fusion development. The spin-off demonstrates how cutting-edge research can give rise to new industry: scientific excellence is translated into industrial applications with strong value creation and growth potential. Sourcelight is intended to bring the LDRS (Laser-Driven Radiation Sources) technology developed by Focused Energy into targeted industrial applications. The technology combines laser-driven high-energy X-rays and neutrons in a single system. This enables not only high-resolution imaging, but
Cosylab and Heron Neutron Medical Corp. Sign Letter of Intent to Advance Global Deployment of Accelerator-Based BNCT Systems10.6.2026 11:30:00 CEST | Press release
Cosylab and Heron Neutron Medical Corp. announced today, 10 June 2026, the signing of a Letter of Intent to establish a strategic framework for joint market development to support the global deployment of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) systems. The collaboration aims to accelerate the development and integration of sophisticated software solutions for use with AB-BNCT while strengthening AB-BNCT's international market access and business development. By combining Cosylab's proven expertise in mission-critical software and complex system integration with Heron's end-to-end BNCT platforms, the partnership aims to drive broader global clinical adoption of this highly targeted cancer treatment modality. "AB-BNCT is emerging as one of the most promising approaches for treating difficult-to-treat and recurrent cancers," said Mark Pleško, Chief Executive Officer of Cosylab. "This collaboration reinforces our strategic focus on advancing radiation therapy technologie
GlobalFoundries and Qualinx Demonstrate First European Sovereign Manufacturing Flow for Security‑Critical Semiconductors10.6.2026 11:25:00 CEST | Press release
First end-to-end European chip manufacturing flow proven for aerospace, defence, IoT, consumer electronics and critical infrastructure GlobalFoundries (GF) and Qualinx today announced the successful completion of the first fully European-based, end-to-end semiconductor manufacturing flow at GlobalFoundries’ Dresden fab on its FDX technology. The milestone demonstrates that security-critical chips for aerospace, defence and critical infrastructure can be designed, manufactured and delivered entirely within Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610196220/en/ In this partnership, Qualinx served as the launch customer with a sophisticated GNSS SoC design for secure Positioning, Navigation and Timing (PNT) applications. The QLX3xx design targets sovereign GNSS-based PNT solutions for aerospace, defence and critical infrastructures—such as resilient timing and synchronization networks and highly integrated, ult
LTM Introduces BlueVerse™ Currency to Enable Outcome-Based Pricing in the Agentic AI Era10.6.2026 10:30:00 CEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today introduced BlueVerse™ Currency, an AI-linked commercial model that prices enterprise work by outcomes rather than effort consumed as enterprises scale agentic AI across core processes. BlueVerse Currency brings together the full BlueVerse stack—People (expertise on demand), Accelerators (reusable assets that speed delivery), Agents (autonomous AI workforce), Platforms (orchestration layer to scale delivery), and Tokens (compute and model usage)—into a single commercial construct. It introduces outcome-linked pricing tied to measurable business results, enabling shared productivity gains so clients can capture AI-driven efficiency value. The model also supports fungible resourcing, enabling reallocation mid-contract to evolving priorities, and faster reinvestment, with savings redirected into innovation. It is underpinned by a hybrid structure with fixed and variable pricing components, supported by use-case–
Smead Capital Management Extends International Value Strategy to Global Investors Through New Fund10.6.2026 09:00:00 CEST | Press release
Firm expands access to long-standing U.S.-based international strategy, bringing disciplined, value-driven investing to a broader global audience through the Smead Global ex-US Value UCITS Fund Smead Capital Management, a Phoenix-based investment management firm and a leader in value investing, today announced the launch of the Smead Global ex-US Value UCITS Fund designed to provide global investors with access to a product modeled after the firm’s long-standing Smead International Value Strategy. The Smead Global ex-US Value UCITS Fund is domiciled in Luxembourg. Investors can access the fund through Smead Capital Management’s website and it is available to professional and qualified investors through the fund’s transfer agent. The strategy that the Smead Global ex-US Value UCITS Fund is modeled after, the Smead International Value Strategy, has been a core contributor to Smead Capital Management’s outstanding performance for over a decade. Like all Smead products, the Global ex-US Va
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