DE-INCYTE
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
Lenovo Group: Second Quarter Financial Results 2025/2620.11.2025 00:45:00 CET | Press release
Lenovo delivers record quarterly results, marking significant progress in hybrid AI Lenovo GroupLimited (HKSE: 992) (ADR: LNVGY), together with its subsidiaries (‘the Group’), today reported record results for the second quarter of fiscal year 2025/26, with overall group revenue reaching an all-time high of US$20.5 billion, up 15% year-on-year. Adjusted net income[1] grew 25% year-on-year to US$512 million, and adjusted net income margin expanded to 2.5%, driven by higher revenues. Together, these reflect the strength of the Group’s operational performance as they exclude the impact of non-cash fair value loss on warrants, notional interest on convertible bonds, and other non-cash items. The Group delivered double-digit year-on-year revenue growth across all main business groups and sales geographies. The AI-related revenue mix increased by 13 percentage points year-on-year, accounting for 30% of the Group’s total revenue this quarter. The growth was driven by high-double-digit revenue
OCP Announces Date of Third Quarter and Nine-Month 2025 Earnings19.11.2025 22:05:00 CET | Press release
OCP S.A. (“OCP” or the “Company”), a global leader in the fertilizer industry, will release its third quarter and nine-month 2025 results on Tuesday, November 25, 2025. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal from 9:00 a.m. EDT, 3:00 p.m. Morocco (GMT+1), and 2:00 p.m. London time (GMT). OCP senior management will host a conference call to discuss third quarter and nine-month 2025 results at 10:00 a.m. EDT, 4:00 p.m. Morocco (GMT+1), and 3:00 p.m. London time (GMT) on Tuesday, November 25, 2025, for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing g.laraki@ocpgroup.ma. About OCP OCP is a global leader in the fertilizer industry, backed by almost a century’s
Marquee Brands Broadens Global Portfolio with Strategic Acquisition of Stance19.11.2025 21:00:00 CET | Press release
Marquee’s 19th Brand Signals a Bold Expansion into Lifestyle and Performance Marquee Brands, the premier global brand accelerator, today announced the acquisition of Stance, the innovative lifestyle and performance sock brand. Founded in 2009 in San Clemente, California, Stance joins Marquee Brands’ renowned portfolio, home to some of the world’s most notable brands, including Martha Stewart, Laura Ashley, Sur La Table, BCBG, Ben Sherman, Body Glove and Dakine. The addition of Stance brings total retail sales across Marquee’s portfolio to $4.5 Billion USD. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251119216623/en/ Marquee also announces a new partnership with United Legwear and Apparel Co. (ULAC), which becomes the brand’s core global licensee, managing operations across all territories apart from China. With products sold in 42 countries through more than 1,100 U.S. wholesale accounts, e-commerce, international distrib
AWS and HUMAIN Expand Partnership with NVIDIA AI Infrastructure and AWS AI Chip Deal to Drive Global AI Innovation19.11.2025 19:38:00 CET | Press release
Expanded partnership includes deployment of up to 150,000 AI accelerators including the latest NVIDIA GB300s AI infrastructure and AWS’s Trainium chips.Amazon Bedrock will provide customers access to best-in-class foundation models optimized across diverse, high performance AI chip infrastructures.AWS becomes HUMAIN’s preferred AI partner with AWS and HUMAIN collaborating to bring AI compute and services to customers worldwide. Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), and HUMAIN, a Public Investment Fund (PIF) company delivering global full-stack AI solutions, announced today at the U.S.-Saudi Investment Forum their plans to provide, deploy and manage up to 150,000 AI accelerators in a data center facility known as an “AI Zone” in Riyadh. As part of the expanded partnership, AWS will become HUMAIN’s preferred AI partner globally, and the two companies will collaborate to bring AI compute and services from Saudi Arabia to customers worldwide. This pre
Luma AI Raises $900 Million Series C Led by HUMAIN And Partners on 2 Gigawatt AI Supercluster in Saudi Arabia19.11.2025 18:15:00 CET | Press release
New capital and compute infrastructure will accelerate Luma AI’s path towards Multimodal AGI – AI that can simulate reality and help humans in the physical world.HUMAIN to build Project Halo, one of the world’s largest AI compute clusters that will include the training of World Models, the next step in AI after LLMs - a potential trillion-dollar opportunity spanning entertainment, marketing/brands, education, world understanding, and robotics industries.Partnership includes HUMAIN Create, an initiative to build AI models trained on Arabic and regional data, helping enterprises and governments across MENA adopt culturally aligned AI. Luma AI, the frontier artificial intelligence company building multimodal AGI, today announced it has raised $900 million in Series C funding, led by HUMAIN, a PIF company delivering global full-stack AI solutions, with significant participation from AMD Ventures, and existing investors Andreessen Horowitz, Amplify Partners, and Matrix Partners. This press
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