Incyte Genomics Inc - INCY STOCK NEWS

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.

Incyte announced that the Phase 3 RUXCOVID study of ruxolitinib for treating COVID-19 associated cytokine storm did not meet its primary endpoint. Data indicated no significant reduction in severe complications or mortality among patients receiving ruxolitinib compared to standard-of-care alone (12.0% vs. 11.8%). Secondary endpoints also showed no clinically relevant benefits. Despite these disappointing results, ruxolitinib was generally well tolerated. Ongoing analyses will assess the implications for other studies. The results do not affect ongoing non-COVID-19 trials or approved uses of ruxolitinib.

Eli Lilly and Incyte announced publication of peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) in The New England Journal of Medicine. The Phase 3 study demonstrated that baricitinib, combined with remdesivir, shortened recovery times and lowered the risk of progression to ventilation or death in hospitalized COVID-19 patients. This supports the emergency use authorization (EUA) granted by the FDA on Nov. 19. Though not FDA-approved for COVID-19, baricitinib is authorized for use in hospitalized patients requiring supplemental oxygen.

Incyte will present at the 39^th Annual J. P. Morgan Virtual Healthcare Conference on January 11, 2021, at 7:30 a.m. EST. The presentation will be available for live streaming at Investor.Incyte.com and can be replayed for 90 days. Incyte is a biopharmaceutical company based in Wilmington, Delaware, dedicated to addressing serious unmet medical needs through proprietary therapeutics.

Incyte announced data from three Phase 2 studies of parsaclisib, a selective oral PI3Kδ inhibitor, presented at the 62nd ASH Annual Meeting. The studies, CITADEL-203, CITADEL-204, and CITADEL-205, evaluated its efficacy in treating relapsed or refractory lymphomas. Key results include:

• CITADEL-203: ORR 75%, mDOR 14.7 months
• CITADEL-204: ORR 56.9%, NR for mDOR
• CITADEL-205: ORR 71%, mDOR 9.0 months

Parsaclisib showed a manageable safety profile, indicating potential as a treatment option.

Incyte and MorphoSys AG presented preliminary data from the firstMIND study at the 62nd ASH Annual Meeting, focusing on tafasitamab and lenalidomide combined with R-CHOP for newly diagnosed DLBCL patients. Results showed an acceptable tolerability profile, with serious neutropenia and thrombocytopenia more frequent in the combination arm. Objective response rates were high, with 91.1% of patients responding after three cycles. A Phase 3 trial, frontMIND, will evaluate this combination as first-line treatment. Long-term analyses from the L-MIND study also indicated durable responses with no unexpected safety signals.

Incyte announced positive results from the pivotal Phase 3 REACH3 study, demonstrating that Jakafi (ruxolitinib) significantly improved outcomes in patients with steroid-refractory chronic graft-versus-host disease (GVHD) compared to best available therapy. The study recorded an overall response rate (ORR) of 49.7% for Jakafi versus 25.6% for BAT. Key secondary endpoints also showed improved failure-free survival and symptom reduction. No new safety signals were detected. These findings will be presented at the 62nd American Society of Hematology Annual Meeting.