Incyte Corp - INCY STOCK NEWS

Incyte announced that the FDA has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura™) as a treatment for vitiligo in patients aged 12 and older. This cream is a topical JAK inhibitor and could offer a significant treatment option for vitiligo, a chronic autoimmune disease that currently lacks FDA-approved therapies for repigmentation. The FDA’s target action date for the sNDA is April 18, 2022. The application is backed by data from the Phase 3 TRuE-V trials, which showed promising results for patients using the cream.

Incyte will present at two investor conferences in January 2022. The first is the Goldman Sachs 14th Annual Healthcare CEOs Unscripted Conference on January 6 at 3:00 pm EST, followed by the 40th Annual J. P. Morgan Healthcare Conference on January 10 at 7:30 am PST. Both presentations will be streamed live and available for replay on their investor website. Incyte, based in Wilmington, Delaware, focuses on developing innovative therapies to address serious unmet medical needs.

MorphoSys US and Incyte announced findings from the RE-MIND2 study, showing that the combination of tafasitamab (Monjuvi) and lenalidomide significantly improves overall survival (OS) in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The OS for tafasitamab plus lenalidomide was 20.1 months versus 7.2 months for Pola-BR (p=0.038) and 24.6 months versus 7.4 months for R2 (p=0.014). Results suggest tafasitamab plus lenalidomide could be a future backbone therapy for DLBCL, with oral presentations planned at the ASH 2021 meeting.

Incyte announced that data from its CITADEL studies of parsaclisib in treating relapsed or refractory lymphomas were accepted for oral presentation at the 63rd American Society of Hematology Annual Meeting. These findings support Incyte’s New Drug Application (NDA) for parsaclisib, recently accepted by the FDA. Key data highlights include an objective response rate (ORR) of 77.7% for follicular lymphoma and 58.3% for marginal zone lymphoma. Parsaclisib demonstrated a manageable safety profile, reinforcing its potential as a treatment option for these cancers.

OLUMIANT (baricitinib) continues to demonstrate a consistent safety profile in a long-term analysis involving 3,770 rheumatoid arthritis (RA) patients across 14,744 patient years of exposure. The overall incidence rate of adverse events stood at 22.6 per 100 patient years, with serious adverse events at 7.4. Safety results will be presented by Eli Lilly and Company and Incyte at ACR Convergence 2021. A real-world study in Japan involving 3,445 RA patients also showed no new safety signals, reinforcing OLUMIANT's safety over 24 weeks. OLUMIANT is approved in over 75 countries for RA treatment.

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.