Welcome to our dedicated page for Incyte news (Ticker: INCY), a resource for investors and traders seeking the latest updates and insights on Incyte stock.
News for Incyte Genomics Inc (Nasdaq: INCY), operating as Incyte Corporation, centers on its activities as a global biopharmaceutical company focused on Oncology and Inflammation & Autoimmunity. Company releases describe a portfolio of first‑in‑class medicines and a pipeline of proprietary therapeutics, making INCY news particularly relevant for investors and healthcare observers following cancer and immune‑related drug development.
Recent headlines highlight late-stage clinical trial results and regulatory milestones. Incyte has reported positive topline data from the Phase 3 frontMIND trial of tafasitamab (Monjuvi/Minjuvi) plus lenalidomide and R‑CHOP as first‑line therapy for diffuse large B‑cell lymphoma, meeting primary and key secondary endpoints. Other news covers European Commission and Japanese approvals of Minjuvi in combination regimens for relapsed or refractory follicular lymphoma and DLBCL, underscoring the company’s role in B‑cell lymphoma treatment.
In immuno‑oncology, Incyte Biosciences Japan G.K. has announced approval of Zynyz (retifanlimab) with platinum‑based chemotherapy as first‑line treatment for advanced squamous cell carcinoma of the anal canal, following earlier U.S. approval in a similar setting. Additional coverage describes submissions to European regulators and the broader POD1UM clinical program evaluating retifanlimab across solid tumors.
News flow also features pipeline updates for INCA033989, a first‑in‑class mutCALR‑targeted monoclonal antibody for myeloproliferative neoplasms. Incyte has disclosed Breakthrough Therapy designation from the U.S. FDA for essential thrombocythemia with Type 1 CALR mutations, along with Phase 1 data in ET and myelofibrosis showing hematologic responses, spleen volume reductions, symptom improvements and safety findings.
Beyond R&D, Incyte issues releases on leadership changes, board transitions, inducement equity grants and participation in major healthcare investor conferences. For investors and analysts, the INCY news page provides a centralized view of clinical, regulatory, corporate governance and capital markets developments affecting the company.
Incyte announced new results from the Phase 3 TRuE-V clinical trial program evaluating Opzelura (ruxolitinib) in patients with nonsegmental vitiligo. At Week 104, patients who had a high level of facial repigmentation maintained a durable response a year after treatment withdrawal. Continued treatment led to further improvements in facial and total body repigmentation. The results, presented at the 2023 American Academy of Dermatology Annual Meeting, indicate Opzelura's efficacy and safety, as well as its potential as a long-term treatment option for vitiligo.
Incyte (NASDAQ:INCY) has announced multiple abstracts that will be presented during the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place from April 14-19 in Orlando, Florida. Key presentations include findings on pemigatinib in previously-treated solid tumors and five-year results from the L-MIND study of tafasitamab in DLBCL. Notable oral presentations include insights into the development of INCB123667 for breast cancers, as well as the final results of tafasitamab. The meeting will allow virtual access to on-demand sessions until July 19, 2023. For more details, visit the AACR website.
Caris Life Sciences announced a strategic research partnership with Incyte Corporation on March 7, 2023, to enhance precision medicine approaches for Incyte's oncology pipeline. This partnership leverages Caris' advanced molecular science solutions, including comprehensive profiling and AI capabilities, to improve patient outcomes. Initially focusing on two therapeutic programs, Incyte has the option to expand to four. This collaboration aims to optimize clinical trial strategies and discover novel biomarkers, reinforcing Incyte's commitment to developing innovative cancer treatments.
Incyte announced the presentation of new long-term data from the Phase 3 TRuE-V trials for Opzelura (ruxolitinib) cream, focused on vitiligo, at the upcoming 2023 AAD Annual Meeting in New Orleans. Two late-breaking oral presentations will detail durability and long-term response, with safety and efficacy data from a Phase 2b study of povorcitinib (INCB54707) also highlighted. Incyte will host an in-person event on March 18, 2023, to discuss these key findings. Opzelura is the first FDA-approved treatment for repigmentation in nonsegmental vitiligo and shows promise for other dermatological conditions.
Incyte announced the discontinuation of the Phase 3 LIMBER-304 trial after an independent data monitoring committee determined it was unlikely to meet its primary endpoint. This trial evaluated the efficacy and safety of parsaclisib combined with ruxolitinib in patients with myelofibrosis who did not respond adequately to ruxolitinib alone. The decision to halt the study was not due to safety concerns. Incyte will review the data and is expected to present findings at a future scientific meeting. The primary endpoint was the reduction in spleen volume, with secondary endpoints including symptom score changes and overall survival.
Incyte announced a positive opinion from the CHMP recommending the approval of ruxolitinib cream (Opzelura) for treating non-segmental vitiligo, marking it as the first treatment for repigmentation available in the EU. With about 1.5 million patients affected in Europe, the recommendation is based on Phase 3 trial data showing significant improvements in facial and total body repigmentation. The European Commission will review the opinion, which, if approved, will provide a critical treatment option for patients aged 12 and older, addressing a significant unmet medical need in dermatology.
Incyte, a biopharmaceutical company based in Wilmington, Delaware, announced its participation in the Cowen 43rd Annual Health Care Conference. The event is scheduled for March 6, 2023, at 11:10 a.m. (EST) in Boston. The presentation will be available via live webcast on Investor.Incyte.com, with a replay option available for 30 days post-event. Incyte is dedicated to developing proprietary therapeutics addressing serious unmet medical needs. For more details, visit Incyte.com.
Incyte announced positive 52-week results from a Phase 2 study on the oral JAK1 inhibitor povorcitinib for treating hidradenitis suppurativa (HS). The trial demonstrated sustained efficacy, showing significant reductions in abscess and inflammatory nodule counts across all treatment arms. At Week 52, 22-29% of patients achieved complete response (HiSCR100). The open-label extension indicated consistent tolerability, with common adverse events including COVID-19 and acne. The study's findings affirm the potential of povorcitinib as a viable long-term treatment for this debilitating skin condition.
Incyte reported a robust financial performance for FY'22, with total net product revenues reaching $2.75 billion, a growth of 18% year-over-year. The company achieved total revenues of $3.4 billion, up 14% YOY. Jakafi net revenues amounted to $2.41 billion, marking a 13% increase, while guidance for 2023 forecasts Jakafi revenues between $2.53 and $2.63 billion. Opzelura Cream also showed significant demand, generating $61 million in Q4'22 alone. The company is optimistic about upcoming clinical trial results and has received a six-month patent extension for Jakafi, now expiring in December 2028. They hold a conference call today at 8:00 a.m. ET to discuss further details.
Incyte (NASDAQ:INCY) will present at the Guggenheim Healthcare Talks Oncology Day on February 8, 2023, at 1:35 p.m. (EST) in New York. This presentation will be available for live webcast and can be accessed via Investor.Incyte.com. A replay of the event will be available for 30 days after the broadcast.
Based in Wilmington, Delaware, Incyte is a global biopharmaceutical company dedicated to addressing serious unmet medical needs through the development and commercialization of proprietary therapeutics. For more insights, visit Incyte.com.
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