Incyte Genomics Inc - INCY STOCK NEWS

Incyte reported Q4 2021 revenues of $862.9 million, up 9% year-over-year, with total product and royalty revenues of $813 million (+20%) and Jakafi revenues of $592 million (+15%). The company projects Jakafi revenues of $2.3 to $2.4 billion for 2022. Incyte successfully launched Opzelura in atopic dermatitis, treating nearly 19,000 patients by year-end. The FDA has accepted a supplemental application for Opzelura in vitiligo, with a decision expected by April 18, 2022. The company ended 2021 with $2.3 billion in cash and marketable securities.

Incyte will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 11:20 a.m. ET. The event will be held virtually, and the presentation will be accessible via a live webcast on Investor.Incyte.com, with a replay available for 30 days. Incyte, based in Wilmington, Delaware, focuses on developing proprietary therapeutics to address serious medical needs. For more information, visit Incyte.com.

Eli Lilly and Incyte provided updates on the Phase 3 development for OLUMIANT (baricitinib) in systemic lupus erythematosus (SLE) and atopic dermatitis. The Phase 3 lupus program has been discontinued after the SLE-BRAVE-I study met its primary endpoint, while SLE-BRAVE-II did not. Ongoing discussions with the FDA may lead to a Complete Response Letter for the atopic dermatitis sNDA due to lack of alignment on the indicated population. Lilly remains committed to other research with OLUMIANT, including potential regulatory approvals for COVID-19 and alopecia areata in 2022.

Incyte announced the withdrawal of its New Drug Application (NDA) for parsaclisib in the U.S. for treating relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. This decision follows discussions with the FDA on confirmatory studies that could not be completed in a timely manner. Additionally, Incyte has opted out of the continued development of MCLA-145, but will maintain collaboration with Merus. Parsaclisib remains in ongoing Phase 2 and Phase 3 trials for other indications.

Incyte has set a conference call for its Q4 and year-end 2021 financial results at 8:00 a.m. ET on February 8, 2022. The corresponding press release will be issued earlier that day at 7:00 a.m. ET. Investors can access the live webcast at Investor.Incyte.com. A replay will be available for 90 days post-event. Incyte, based in Wilmington, Delaware, focuses on developing therapeutics to address unmet medical needs.

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.