DE-INCYTE
21.8.2024 17:41:34 CEST | Business Wire | Press release
Incyte (Nasdaq: INCY) today announced that the Company will present key data from its oncology portfolio at the upcoming European Society of Medical Oncology (ESMO) Congress 2024, to be held September 13-17 in Barcelona and virtually.
"The data at ESMO underscore the progress across our oncology portfolio and the potential to impact patients where additional treatment options are needed. Notably, a Presidential Symposium will feature new, pivotal results from the Phase 3 POD1UM-303/InterAACT2 study of retifanlimab (Zynyz®) for the treatment of squamous cell anal carcinoma (SCAC). The POD1UM-303 data will support the supplemental Biologics License Application (sBLA) filing for retifanlimab in SCAC planned by year end 2024," said Pablo Cagnoni M.D., President, Head of Research and Development, Incyte. "We will also present new data on INCB123667, a potential first-in-class CDK2 inhibitor, which we believe has the potential to enhance outcomes and serve as a foundational treatment for platinum-resistant ovarian and other cancers."
Details on the abstracts accepted for presentation at ESMO include:
Presidential Symposium
Retifanlimab (PD-1)
POD1UM-303/InterAACT2: Phase 3 Study of Retifanlimab With Carboplatin-Paclitaxel (C-P) in Patients (Pts) With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal (SCAC) Not Previously Treated With Systemic Chemotherapy
Presidential Symposium I: Practice-changing trials. Presentation Number: LBA2. Presentation Time: 10:50-11:02 a.m. ET (4:50-5:02 p.m. CET), September 14, 2024
Mini Oral Session
INCB123667
Safety and Tolerability of INCB123667, a Selective CDK2 Inhibitor, in Patients (Pts) With Advanced Solid Tumors: A Phase 1 Study
Mini oral session: Developmental therapeutics. Presentation Number: 617MO. Presentation Time: 9:35 – 9:40 a.m. ET (3:35-3:40 p.m. CET), September 14, 2024
Conference Call and Webcast
Incyte will host an in-person analyst and investor event on Saturday, September 14, 2024, from 1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST) to discuss key data presentations at ESMO including data from the POD1UM-303 Presidential Symposia and its CDK2 inhibitor program. The CDK2 data presentation will include new results from a later data cut-off, as well as the data included in the ESMO accepted abstract and mini-oral presentation. 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 90 days.
Conference call details will be provided on the Investor section of Incyte.com.
Abstracts will be available to registered attendees on the ESMO Virtual Congress platform beginning on September 9, 2024. All accepted abstracts will be published in the ESMO Congress 2024 Abstract Book, a supplement to the official ESMO journal, Annals of Oncology.
More information regarding the 2024 ESMO Congress can be found at https://www.esmo.org/meeting-calendar/esmo-congress-2024.
About Retifanlimab (Zynyz®)
Retifanlimab (Zynyz®), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a trademark of Incyte.
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.
Incyte 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, the potential for retifanlimab and INCB123667 to positively impact patients and plans to submit an sBLA for retifanlimab in SCAC by year end 2024, contain predictions, estimates, and other forward-looking statements.
These forward-looking statements are based on our current expectations and are 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 and the ability to enroll subjects in accordance with planned schedules; determinations made by the FDA and regulatory agencies outside of the United States; the efficacy or safety of our products; the acceptance of our products in the marketplace; market competition; unexpected variations in the demand for our products and the products of our collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for our products; sales, marketing, manufacturing, and distribution requirements, including our ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional new products that become approved; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-Q for the quarter ended June 30, 2024. We disclaim 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/20240821420609/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
VerSprite Launches Fork and Knife: AI-Driven Threat Modeling and Adversarial Testing Built for the Speed of Modern Software26.6.2026 23:28:00 CEST | Press release
Powered by the risk-centric PASTA methodology and two decades of accredited offensive security, the integrated platform lets enterprises threat model in a security sprint—then prove the risk through AI-led, human-on-the-loop testing. VerSprite, a global leader in risk-based threat modeling and the firm behind the PASTA (Process for Attack Simulation and Threat Analysis) methodology, today announced the general availability of Fork (www.forktm.com), a continuous application threat modeling platform, alongside Knife, an AI-led, human-on-the-loop adversarial testing platform for web applications and web API endpoints. Together, the two products operationalize a new model for product security—one where applications are securely designed, continuously modeled, and actively tested as part of the build process itself. The launch addresses a problem every security leader knows but few tools have solved: threat modeling is essential, never more so than in an AI-driven era, yet it has remained s
Venture Global Announces Closing of $1.5 Billion Senior Secured Vessel Financing Facility26.6.2026 22:30:00 CEST | Press release
Venture Global, Inc. (NYSE: VG) announced today that its wholly-owned subsidiary, Venture Global Shipping Holdings, LLC (“VGSH”), has entered into a Credit and Guaranty Agreement providing for a senior secured term loan facility (the “Facility”) in an aggregate principal amount of up to $1,500,000,000. The Facility will mature on June 26, 2032. Deutsche Bank and ING acted as coordinating lead arrangers for the Facility. ING also serves as facility agent and security trustee. VGSH intends to use the net proceeds from the Facility for general corporate purposes, including to reimburse Venture Global LNG, Inc. for payments previously made by it or its affiliates in connection with the acquisition of nine LNG carriers, funding certain reserve accounts, and paying transaction fees and expenses. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (“LNG”) with over 100 MTPA of capacity in production, construction, or development. Ven
Andersen Consulting tilføjer House of Code for at styrke teknologi- og dataløsninger26.6.2026 20:01:00 CEST | Pressemeddelelse
Andersen Consulting forstærker sine kompetencer inden for teknologisk transformation gennem en samarbejdsaftale med House of Code, en global virksomhed med hovedkvarter i USA, der specialiserer sig i datadrevne platforme, automatisering og agentbaserede ai-løsninger. House of Code blev stiftet i 2001 og udvikler softwareløsninger samt yder rådgivning til energihandels- og finanssektoren med kunder, der spænder over hedgefonde, kapitalfonde og forsyningsvirksomheder. Virksomheden besidder dyb ekspertise inden for energihandel og risikostyring og hjælper organisationer med systemimplementering, forretningstransformation, dataautomatisering og ai-underbygget modernisering af arbejdsgange. Deres proprietære platform, Enterprise Platform for Integrated Compliance (EPIC), skaber en mere effektiv datastyring, automatiserer rapporteringsprocesser, forbedrer den driftsmæssige gennemsigtighed på tværs af virksomhedssystemer og skaber et fundament for opbygning af intelligente, agentbaserede arbe
Capco Recognized by OpenAI for Innovation and Responsible AI Leadership26.6.2026 20:00:00 CEST | Press release
Receives AI Governance & Risk Excellence Award at OpenAI Partner SummitCapco’s UK AI Lab wins OpenAI Codex Hackathon Global management and technology consultancy Capco, a Wipro company,has been recognized by OpenAI for both AI innovation and responsible AI leadership. Capco received the AI Governance & Risk Excellence Award at the recent OpenAI Partner Summit 2026 in San Francisco, highlighting Capco’s ability to deliver enterprise-grade AI outcomes in highly regulated environments. The award recognizes Capco’s expert advantage when helping financial services and energy organizations to scale AI with confidence, balancing innovation with strong governance to reduce risk, strengthen compliance and improve customer outcomes. This award follows Capco winning the OpenAI Codex Hackathon, where its UK AI Lab competed against more than 30 teams and over 100 participants from across the OpenAI partner ecosystem. Capco's winning entry Sentra – a consulting-led, AI-powered retail banking solutio
Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release
If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids
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