DE-INCYTE
4.3.2024 14:01:27 CET | Business Wire | Press release
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240304329736/en/
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
2PointZero Group Signals Global Scale With Revenue Surge to AED 21.9 Billion and Net Profit of AED 7.7 Billion in H1 202631.7.2026 13:42:00 CEST | Press release
Group revenue growth supported by stable gross profit margin of 29%, and adjusted EBITDA of AED 5.0 billionGlobal expansion milestones include the completed sale of TAQA stake, and the acquisition of Traverse Midstream Partners in North America, Baobab Group in Africa, and 60.8% of ISEM in ItalyTIME ranks the Group 36th on the World’s Growth Leaders list for 2026, highlighting market stability, operational scale and disciplined approach to capital 2PointZero Group (ADX: 2POINTZERO), a leading Abu Dhabi-based investment holding firm, announced its financial results for the first half of 2026, reporting revenue of AED 21.9 billion and delivering a Group Net Profit of AED 7.7 billion. This robust performance is reflected in the Group’s adjusted EBITDA, which reached AED 5.0 billion after excluding fair value changes and one-offs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260731538982/en/ Samia Bouazza, CEO of 2PointZero (P
Datroway® Approved in the EU as Only TROP2 Directed Medicine with Overall Survival Benefit for the First-Line Treatment of Patients with Metastatic TNBC Who Are Not Candidates for Immunotherapy31.7.2026 08:30:00 CEST | Press release
Approval based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival Datroway now approved for two breast cancer indications in the EU Datroway® (datopotamab deruxtecan) has been approved in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The approval by the European Commission follows the positive opinionof the Committee for Medicinal Products for Human Use of the European Medicines Agency and is based on result
Polpharma Biologics Announces FDA and EMA Acceptance for Review of PB016 Vedolizumab Biosimilar Candidate31.7.2026 08:30:00 CEST | Press release
Polpharma Biologics International AG today announces that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted for review the Biologics License Application (BLA) and Marketing Authorisation Application (MAA), respectively, for PB016, a proposed vedolizumab biosimilar candidate to Takeda’s reference product Entyvio®* (vedolizumab) lyophilized vial for intravenous (IV) administration for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. The BLA and MAA acceptances represent significant milestones in Polpharma Biologics' development program and underscore the company's commitment to advancing high-quality biosimilars and expanding global access to affordable biologic medicines. "FDA and EMA acceptances for review of our IV vedolizumab biosimilar candidate mark a major achievement for Polpharma Biologics and validate our deep scientific expertise in biosimilar development and manufacturing," said
SES: Disclosure of Share Buyback Transactions31.7.2026 07:30:00 CEST | Press release
In the time period from June 2, 2026 until and including June 23, 2026, a number of 213,167 shares were bought back within the framework of the share buyback of SES to meet obligations under SES’s Equity Based Compensation Plan (EBCP). Shares were bought back as follows: Day of purchase Aggregated volume in shares Daily weighted average acquisition price of shares (EUR) Market June 2, 2026 27,097 8.8727 DXE June 2, 2026 72,903 8.8556 ENX June 5, 2026 16,624 8.3723 DXE June 5, 2026 31,510 8.4266 ENX June 15, 2026 26,451 7.8423 XPAR June 17, 2026 26,812 7.3910 XPAR June 23, 2026 11,770 7.2200 XPAR The transactions in a detailed form are published on SES’s website: https://www.ses.com/investors/shareholder-information/share-buy-backs. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, busin
Half-Year Report on SES’s Liquidity Contract31.7.2026 07:30:00 CEST | Press release
Pursuant to the liquidity contract entered into by SES with BNP Paribas as of 7 April 2026, please see the below update on the progress of the liquidity services. When the liquidity services were implemented as of 7 April 2026, the following assets were in the liquidity account: € 2,500,000 As of 30 June 2026, the following assets appeared on the liquidity account: 228,186 shares; € 816,880. Over the period from 7 April 2026 to 30 June 2026, the following transactions were executed: 1,082 buy transactions; 1,308 sales transactions. Over this same period, the volumes traded represented: 1,093,335 shares and € 8,485,986 on the buy side; 873,399 shares and € 6,860,843 on the sell side. Follow us on: LinkedIn | Facebook | YouTube | X | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we believe that space has the power to make a difference. That’s why we design space solutions that help governments protect, businesses grow, and people stay connected—no matter where th
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