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
International Human Rights Lawyer Jared Genser and Former White House Counsel Lanny J. Davis Join Legal and Advocacy Team Supporting Cambodian Businessman Yim Leak, Seiden Law LLP Announces18.9.2026 19:52:00 CEST | Press release
Jared Genser, one of the world's most recognized international human rights lawyers, and Lanny J. Davis, an adviser to former presidents George W. Bush and Bill Clinton, join the legal and advocacy team for Cambodian businessman Yim Leak and challenge what they call a coordinated smear campaign in Thailand. International human rights lawyer Jared Genser and Lanny J. Davis, who has close ties to two former US presidents and a worldwide reputation for defending those under attack with lies and smears, and for repairing the damage done to their reputations, have joined the legal and advocacy team supporting Cambodian businessman Yim Leak, Seiden Law LLP, which serves as Yim Leak's chief global counsel, announced today. Their first move is to hold the Thai government accountable, framing its conduct as either complicit in or willfully blind to a sustained smear campaign against Yim. Genser is Managing Director of Perseus Strategies, an international law firm. Over more than two decades, he
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 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 Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
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