Incyte Genomics Inc - INCY STOCK NEWS

Incyte will present at the Evercore ISI 4th Annual HealthCONx Conference (Virtual) on Tuesday, November 30, 2021, at 2:15 p.m. ET. This presentation will be webcast live and accessible at Investor.Incyte.com, with a replay available for 30 days. Based in Wilmington, Delaware, Incyte is a global biopharmaceutical company focused on developing proprietary therapeutics to address serious unmet medical needs.

Cellenkos Inc., a biotech firm specializing in T regulatory (Treg) cell therapies for autoimmune and inflammatory disorders, has completed a $15 million Series A financing led by BVCF Management. This funding will enhance the development of their Treg therapy platform, addressing significant unmet healthcare needs. The company’s lead products include CK0802 for Acute Respiratory Distress Syndrome and CK0804 for Myelofibrosis. Cellenkos aims to launch Phase 1b trials for CK0804 in collaboration with Incyte Corporation, with key clinical trial data expected at the American Society of Hematology meeting on December 13, 2021.

Incyte announced the presentation of over 35 abstracts showcasing data from its oncology portfolio at the 63rd American Society of Hematology (ASH) Annual Meeting, taking place from December 11–14, 2021, in Atlanta, Georgia. Key findings include new data from the CITADEL program on parsaclisib and the RE-MIND2 study on tafasitamab. The company emphasizes its commitment to addressing urgent medical needs in cancer treatment through these presentations.

Incyte reported Q3 2021 total revenues of $813 million, up 31% year-over-year, with product and royalty revenues of $778 million (+25%). Jakafi revenues reached $547 million, increasing 12% versus Q3 2020. The company received three significant regulatory approvals, including Opzelura for atopic dermatitis. Incyte's CEO highlighted the transformation in revenue diversification and a strong pipeline with ongoing trials for several products, including Jakafi and the collaboration on axatilimab.

Incyte (Nasdaq:INCY) announced its participation in the Society for Immunotherapy of Cancer’s 36th Annual Meeting from November 10-14, 2021. Key presentations include a late-breaking poster on Retifanlimab for recurrent MSI-H/dMMR endometrial cancer and a Phase 1 study on an oral PD-L1 inhibitor for advanced solid tumors. An investor conference call will occur on November 13, 2021, discussing oral PD-L1 clinical developments. Full abstracts will be available on SITC’s website starting November 9, 2021.

Incyte announced the FDA's acceptance of its New Drug Application (NDA) for parsaclisib, a next-generation oral inhibitor, to treat relapsed/refractory follicular, marginal zone, and mantle cell lymphomas. The FDA granted Priority Review for marginal zone and mantle cell cases, with a target decision date of April 30, 2022. The NDA for follicular lymphoma has a Standard Review status and a target date of August 30, 2022. Parsaclisib showcased a manageable safety profile in Phase 2 studies, highlighting its potential in addressing significant unmet medical needs.

Incyte announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for ruxolitinib cream as a treatment for non-segmental vitiligo in adolescents and adults. This validation signifies that the MAA is now ready for formal review. The application is backed by data from the Phase 3 TRuE-V clinical trials, which involved over 600 participants and demonstrated significant improvements in skin repigmentation. Ruxolitinib cream is also approved for mild to moderate atopic dermatitis in the U.S.

Incyte has scheduled its Q3 2021 financial results conference call for 8:00 a.m. ET on November 2, 2021. The related press release will be available at 7:00 a.m. ET on the same day. Investors can access the live webcast at Investor.Incyte.com, which will remain available for 90 days. For those unable to attend, a replay will be available via dial-in numbers provided, using conference ID 13724199. This session is crucial for stakeholders to assess the company's performance and future outlook.

Incyte has announced the results from its pivotal Phase 3 TRuE-V clinical trial for ruxolitinib cream (Opzelura™) in patients aged 12 and above with nonsegmental vitiligo. After 24 weeks, 29.9% of patients showed ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75). More than 51% achieved ≥50% improvement in F-VASI. The overall safety profile remained consistent, with no severe treatment-related adverse events reported. Incyte plans to submit marketing applications to the FDA and EMA by the end of 2021.