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
Andersen Global tilføjer Andersen in Indonesia25.6.2026 22:21:00 CEST | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Sydøstasien, da VDB Loi in Indonesia skifter navn til Andersen in Indonesia og dermed bliver det nyeste medlemsfirma, der tilslutter sig organisationen. Andersen in Indonesia yder skattemæssig og juridisk rådgivning til multinationale selskaber og udenlandske investorer, der er aktive på det indonesiske marked. Firmaet kombinerer årtiers markedserfaring med en praktisk tilgang, der fokuserer på at levere præcis og individuel rådgivning om komplekse regulatoriske og internationale forhold. "At blive en del af Andersen-brandet afspejler vores engagement i at give kunderne praktisk skattemæssig og juridisk rådgivning af høj kvalitet på grundlag af et bredere internationalt samarbejde," udtalte Tommy Hendharto Oetomo, administrerende partner for Andersen in Indonesia. "Kunder, der driver virksomhed i Indonesien, har brug for stadig mere koordineret støtte på tværs af landegrænser. At blive et medlemsfirma styrker vores evne til at levere den se
I-Pulse Signs Definitive Agreement with the U.S. Department of Commerce for $250 Million CHIPS R&D Award25.6.2026 20:53:00 CEST | Press release
■I-Pulse Will Develop Cutting-Edge Semiconductors that Support American Reindustrialization and National Security Goals■I-Pulse’s Technology Enables Cost-Competitive Development of America’s Vast Untapped Geothermal Energy Resources I-Pulse Co-founders Robert Friedland, CEO, and Laurent Frescaline, CTO, announced today a definitive agreement with the U.S. Department of Commerce’s CHIPS Research and Development Office for a $250 million award for the further development of I-Pulse’s proprietary semiconductor and pulsed power technology. “With today’s announced investment, the Trump administration is strengthening America’s capabilities and enhancing its national and energy security goals,” said Secretary of Commerce, Howard Lutnick. Co-founder Robert Friedland said: “We are excited to partner with the U.S. government to advance our unique, American technology suite to benefit our great nation. This award supports the development of world-leading critical components in the pulsed power t
Burjeel Holdings Prices First MENA Healthcare Sukuk Since 2018, 3.2x Oversubscribed25.6.2026 19:31:00 CEST | Press release
Burjeel Holdings, a leading super-specialty healthcare group in the GCC listed on the Abu Dhabi Securities Exchange, priced its inaugural USD 500 million Regulation S 5-year senior unsecured Sukuk offering due 2031 under its newly established USD 1.5 billion Senior Unsecured Sukuk Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625449702/en/ Burjeel Holdings’ inaugural Sukuk was priced at a 7.000 % profit rate and a yield of 7.125% (Photo: AETOSWire) The offering attracted significant demand from high-quality international and regional investors, with the orderbook peaking at USD 1.6 billion, representing 3.2x oversubscription. The strength of the orderbook enabled Burjeel to tighten pricing from initial price thoughts in the mid-7% area, with the Sukuk priced at a 7.000% profit rate and a yield of 7.125%, representing the lowest 5-year yield by a GCC-based private non-investment grade corporate issuer since 202
Fossil Fuels Are a Thing of the Past; The Future Is Renewable: The Smarter E Europe Concludes With a Clear Message25.6.2026 19:03:00 CEST | Press release
Packed halls, a vibrant atmosphere and a buzzing vibe – after three days, The smarter E Europe 2026, Europe’s largest alliance of exhibitions for the energy industry, has come to a successful close. The event held at Messe München offered a glimpse of a future-oriented energy world powered by renewables. A strong signal with a clear message went out to the world from the Bavarian capital: The future is renewable. Renewable energies can help ensure a reliable, secure and cost-effective energy supply around the clock, seven days a week. A total of 2,650 exhibitors from 52 countries – many of whom had expanded their booth space compared with the previous year – demonstrated how this can work. More than 66 percent of exhibitors were from outside of Germany. They presented innovative and market-ready products ranging from virtual power plants, smart grid and load control, smart charging solutions, storage technologies and PV hybrid systems to digital platforms transparently and flexibly.The
HeyGen Doubles to $200M ARR in Eight Months on the Rise of Identity-First AI Video25.6.2026 18:02:00 CEST | Press release
HeyGen, the identity-first AI video platform, today announced it has surpassed $200 million in annual recurring revenue, doubling in eight months. The milestone reflects a rapid shift in how individuals, small businesses, and enterprises adopt AI video: as a scalable layer for human communication across languages, formats, and audiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625305891/en/ HeyGen passes $200M in ARR HeyGen's community now spans more than 30 million users in 196 countries and 175+ languages & dialects, from solopreneurs creating professional social videos for the first time to 85% of the Fortune 100 — who together have created more than 118 million videos. That growth has come with rare capital efficiency: HeyGen generates roughly $2.70 in ARR for every dollar of equity capital raised, making it one of the most capital-efficient venture-backed AI companies in the world. "Crossing $200 million in AR
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