Incyte Genomics Inc - INCY STOCK NEWS

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.

Incyte announced a positive opinion from the European Medicines Agency's CHMP for the conditional marketing authorization of pemigatinib in treating adults with unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion after at least one systemic therapy. The CHMP's recommendation, based on the FIGHT-202 study data, is now under review by the European Commission. If granted, pemigatinib will be the first targeted therapy for this condition in Europe, enhancing treatment options for patients facing poor prognoses.

Incyte announced the FDA's acceptance for Priority Review of its Biologics License Application for retifanlimab, an intravenous PD-1 inhibitor for treating locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC). The BLA is based on data from the Phase 2 POD1UM-202 trial, showing a 14% objective response rate in previously treated patients. Retifanlimab has Orphan Drug Designation, and Priority Review shortens the FDA review period by four months, with a target action date set for July 25, 2021.

Incyte has announced a conference call to discuss its fourth quarter and year-end 2020 financial results, scheduled for February 9, 2021, at 8:00 a.m. ET. The press release will be available earlier that day at 7:00 a.m. ET. Participants can join via a domestic dial-in number (877-407-3042) or an international line (201-389-0864), using conference ID 13715042. A replay of the call will be accessible for 30 days. Incyte is dedicated to addressing serious medical needs through the development of proprietary therapeutics.

Incyte (Nasdaq: INCY) has partnered with Cellenkos, Inc. to study the combination of ruxolitinib and CK0804 for treating myelofibrosis (MF). This collaboration includes an option for Incyte to acquire exclusive rights to CK0804 and its variants. The Phase 1b study will be funded by Incyte and operationalized by Cellenkos, with a potential $20 million licensing fee and up to $294.5 million in milestone payments. This initiative aligns with Incyte's LIMBER program aimed at enhancing treatments for myeloproliferative neoplasms.