Incyte Genomics Inc - INCY STOCK NEWS

Incyte has received approval from Japan's Ministry of Health for Pemazyre® (pemigatinib), targeting patients with unresectable biliary tract cancer (BTC) featuring FGFR2 fusion genes, following chemotherapy failure. This milestone underscores Incyte's commitment to addressing unmet medical needs. The approval stems from the FIGHT-202 study, where Pemazyre showed a 36% overall response rate in patients with FGFR2 fusions. Notably, the Japanese market has designated this as an orphan drug, facilitating quicker access for rare disease treatments.

Incyte announced results from the Phase 3 DEVENT study assessing ruxolitinib's efficacy in COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). The study did not meet its primary endpoint for overall mortality reduction. However, significant improvements in mortality were noted in the U.S. patient population for both 5mg and 15mg ruxolitinib doses compared to placebo. The safety profile was consistent with existing data. Incyte plans to provide ruxolitinib at no cost to eligible patients through an Expanded Access Program, subject to FDA agreement.

Incyte (Nasdaq: INCY) will present multiple abstracts at the AACR Annual Meeting 2021, showcasing clinical and pre-clinical data from its oncology portfolio. Key highlights include data on INCB106385, an A2A/A2B receptor antagonist, and INCA00186, a CD73 monoclonal antibody. Other presentations will focus on the LIMBER development program, especially a Phase 2 study combining ruxolitinib and parsaclisib for myelofibrosis. All sessions will be available on demand from April 10, 2021, through June 21, 2021.

Eli Lilly and Company and Incyte announced positive top-line results from the BRAVE-AA2 Phase 3 trial for baricitinib in treating severe alopecia areata (AA). Both 2-mg and 4-mg doses showed statistically significant scalp hair regrowth at Week 36 compared to placebo. Baricitinib, designated as Breakthrough Therapy by the FDA, aims to address the unmet needs of AA patients, with no current FDA-approved treatments available. The trial involved 546 diverse participants, with no reported severe adverse events. Detailed results will be presented at upcoming conferences.

Incyte announced the validation of its Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, by the European Medicines Agency (EMA) as a treatment for adult patients with advanced squamous cell anal carcinoma (SCAC) who have progressed on or are intolerant to platinum-based chemotherapy. This validation confirms the submission's completeness for formal review. Retifanlimab has been accepted for Priority Review by the U.S. FDA, marking a significant step towards new treatment options for SCAC patients in Europe, where the incidence is on the rise.

Incyte announced that the FDA has accepted the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi) to treat steroid-refractory chronic graft-versus-host disease (GVHD) in patients aged 12 and older. The FDA's Priority Review designation will expedite the review process to six months. This sNDA is based on the REACH3 study results, where ruxolitinib demonstrated a significantly higher overall response rate (49.7% vs. 25.6%) compared to best available therapy. The target action date for the FDA decision is June 22, 2021.

Incyte announced the FDA's acceptance for Priority Review of its NDA for ruxolitinib cream, a selective JAK1/JAK2 inhibitor for atopic dermatitis. This decision is backed by data from the Phase 3 TRuE-AD trials involving over 1,200 participants aged 12 and older. The NDA submission includes a priority review voucher, aiming for a target action date of June 21, 2021. Atopic dermatitis affects over 21 million in the U.S., causing significant skin inflammation and itching. The cream is also under development for vitiligo.

Incyte will present at the Cowen 41^st Annual Health Care Conference on March 3, 2021, at 2:00 p.m. EST. The event will be available via a live webcast on Investor.Incyte.com, with a replay accessible for 90 days post-event. As a biopharmaceutical company based in Wilmington, Delaware, Incyte focuses on addressing serious medical needs through the development and commercialization of innovative therapeutics. For more information, visit Incyte.com.

Incyte reported robust financial results for Q4 and full year 2020, highlighting strong revenue growth fueled by Jakafi's demand and successful launches of Monjuvi and Pemazyre. The company anticipates regulatory decisions on seven new applications in 2021, including potential FDA approval for ruxolitinib cream by mid-year. Key clinical advancements include ongoing Phase 3 trials for ruxolitinib combined with parsaclisib for myelofibrosis and a new collaboration with Cellenkos for innovative treatments in hematology.