DE-INCYTE
13.9.2021 22:32:09 CEST | Business Wire | Press release
Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with vitiligo and atopic dermatitis (AD) will be presented at the upcoming European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, held virtually from September 29-October 2, 2021.
The 24-week data from the Phase 3 TRuE-V program evaluating the safety and efficacy of ruxolitinib cream in adolescent and adult patients (age ≥12 years) with vitiligo will be presented as a late-breaking oral presentation. Incyte previously announced that both the TRuE-V1 and TRuE-V2 studies met the primary and key secondary endpoints.
“We look forward to sharing data demonstrating the potential of ruxolitinib cream as an effective treatment option for patients living with vitiligo with the dermatology community at this year’s EADV virtual congress,” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. “These data from the Phase 3 TRuE-V program underscore our commitment to bringing new therapies to patients with challenging skin diseases.”
Key abstracts include:
Late-Breaking Oral Presentation
Vitiligo
Efficacy and Safety of Ruxolitinib Cream for the Treatment of Vitiligo: 24-Week Results From 2 Randomized, Double-Blind Phase 3 Studies (Abstract #D3T01.2A. Session: Late Breaking News. Saturday, October 2, 5:15-6:15 a.m. ET)
Oral Presentation
Atopic Dermatitis
Efficacy and Safety of Ruxolitinib Cream among Patients Aged ≥65 Years with Atopic Dermatitis: Pooled Results from Two Phase 3 Studies (Abstract #FC01.01. Session: Atopic dermatitis/Eczema. Thursday, September 30, 4:00-4:10 a.m. ET)
Poster Presentations
Atopic Dermatitis
Efficacy of Ruxolitinib Cream for the Treatment of Atopic Dermatitis by Baseline Clinical Characteristics (encore) (Abstract #P0187. Session: Atopic dermatitis/Eczema)
Efficacy of Ruxolitinib Cream among Patients with Atopic Dermatitis Based on Previous Medication History (encore) (Abstract #P0192. Session: Atopic dermatitis/Eczema)
Effects of Ruxolitinib Cream in Patients with Atopic Dermatitis with Baseline Body Surface Area ≥10% and Eczema Area and Severity Index Score ≥16 (encore) (Abstract #P0190. Session: Atopic dermatitis/Eczema)
Patient-Reported Outcomes of Ruxolitinib Cream for the Treatment of Atopic Dermatitis (encore) (Abstract #P0188. Session: Atopic dermatitis/Eczema)
More information regarding the virtual conference is available on the EADV website: https://www.eadvcongress2021.org/ . Following the conference, all e-Posters will be made available online on http://www.eadv.org for EADV members.
About Ruxolitinib Cream
Ruxolitinib cream is a proprietary formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.
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 atopic dermatitis, 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 Incyte’s TRuE-V clinical program, whether and when ruxolitinib cream might be approved to treat patients with vitiligo or atopic dermatitis (AD), the potential for success of such treatment, 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 U.S. FDA and other regulatory authorities outside of the United States; 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 June 30, 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/20210913005816/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
Yamaha to Acquire Disguise, Expanding Its Capabilities in Integrated Audio, Video, Lighting and Media13.11.2026 08:00:00 CET | Press release
Acquisition combines Yamaha’s audio expertise with Disguise’s software and media server technologies Yamaha Corporation today announced an agreement to acquire Disguise Technologies Limited (“Disguise”), a London-based provider of software and media server technologies for live and immersive experiences. Yamaha will acquire the company by purchasing all shares in its parent, Butterfly Topco Limited. The acquisition will expand Yamaha’s capabilities beyond audio into integrated audio, video, lighting and media solutions, in line with its strategy to expand beyond hardware into software and services. By combining Yamaha’s audio expertise and global reach with Disguise’s software, technologies and worldwide partner network, the companies will be better positioned to deliver immersive experiences across live entertainment, sports and other venues. Disguise’s technology powers live and immersive experiences worldwide, including tours by Beyoncé and Taylor Swift and venues such as New York’s
Mexico Becomes the First Market Worldwide to Receive Approval for Galderma’s Restylane® Shaype™ for Both Chin and Its First Jawline Indication13.11.2026 07:00:00 CET | Press release
Restylane Shaype is now approved in Mexico for temporary augmentation in the chin area and improvement of jawline definition,1 with launch anticipated in H1 2027 Already approved across various markets globally for the chin area,2 this marks Restylane Shaype’s first approval for the jawline worldwide1 The first-and-only shaper on the hyaluronic acid (HA) market, Restylane Shaype features the firmest HA gel available and is powered by proprietary NASHA HD™ technology, developed to build and shape on bone for instant, natural-looking contour and definition3-6 The approval reinforces Galderma's commitment to advancing innovation in the HA category, enabling the company to meet diverse patient needs Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that Restylane Shaype has been approved for temporary augmentation in the chin area and improvement of jawline definition in Mexico.1 This is the product’s first approval globally for the jawline, and further expan
vVARDIS Announces Pricing of Initial Public Offering13.11.2026 06:02:00 CET | Press release
vVARDIS Holding AG (“vVARDIS”), a Swiss healthcare company operating in the dental med-tech sector, today announced the pricing of its initial public offering of 9,722,223 Class A ordinary shares at a public offering price of $18.00 per share. In connection with the offering, vVARDIS has granted the underwriters a 30-day option to purchase up to an additional 1,458,333 Class A ordinary shares at the initial public offering price to cover over-allotments. The Class A ordinary shares are expected to begin trading on the New York Stock Exchange on November 13, 2026 under the symbol “VVVV.” The closing of the offering is expected to occur on or about November 16, 2026 subject to the satisfaction of customary closing conditions. Goldman Sachs & Co. LLC and J.P. Morgan are acting as joint bookrunning managers for the offering, with William Blair, UBS Investment Bank and Deutsche Bank Securities acting as bookrunners. A registration statement on Form F-1 relating to the offering has been file
Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4*12.11.2026 23:07:00 CET | Press release
The multi-level takeover includes a Throne Room, interactive photo opportunities, special lighting, and more The Empire State Building (ESB) is the gateway to Mount Olympus in Percy Jackson’s world, and now fans can experience the magic like never before. On Nov. 16, the Empire State Building Observation Deck (ESBOD) will unveil “Olympus Awaits,” a multi-level “Percy Jackson and the Olympians” takeover, in partnership with Disney+. The immersive takeover – included with every Observation Deck ticket – will feature an epic Throne Room, interactive photo opportunities, surprise giveaways, ESB x “Percy Jackson” merch, and more, available through Dec. 4, 2026.* This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261112442266/en/ Empire State Building Observation Deck to Debut ‘Olympus Awaits,’ An Immersive ‘Percy Jackson and the Olympians’ Takeover in the Heart of NYC, On Display from Nov. 16 – Dec. 4* “This immersive NYC experience
Clene Nanomedicine Partners with Veristat to Reduce Biostatistical Output Time by 80% for ALS New Drug Application12.11.2026 18:09:00 CET | Press release
Veristat’s InStat™ delivers submission-ready tables, listings, and figures (TLFs) in one week using validated statistical engines, shortening the critical path from database lock to submission VeristatTM, a global clinical research organization (CRO) and consultancy specializing in complex studies, announced that it has partnered with Clene Nanomedicine to cut the time to deliver biostatistical outputs for a pivotal ALS drug application submission by 80%. Veristat reduced the time from study data to validated tables, listings and figures (TLFs) from up to six weeks to just one week. Clene, a late-stage biotech company, leveraged Veristat’s recently launched InStat™ platform, the industry’s first zero-code, fully automated solution to accelerate clinical trial processes. Biostatistical TLFs sit on the critical path for submissions, yet most sponsors rely on antiquated processes that involve slow, manual workflows to produce them, making post-database lock one of the biggest bottlenecks
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