Incyte Genomics Inc - INCY STOCK NEWS

Eli Lilly and Incyte announced that in a sub-study of the COV-BARRIER trial, the use of baricitinib in critically ill COVID-19 patients on mechanical ventilation showed a 46% reduction in 28-day mortality compared to placebo. Specifically, the mortality rate was 39.2% for baricitinib versus 58% for placebo. No new safety issues were reported, and adverse event rates were comparable between groups. The FDA has broadened the Emergency Use Authorization for baricitinib for treating COVID-19 in hospitalized adults and pediatric patients requiring respiratory support.

Incyte Corporation (Nasdaq:INCY) received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application for retifanlimab, an intravenous PD-1 inhibitor aimed at treating advanced squamous cell carcinoma of the anal canal (SCAC). The FDA stated that the application cannot be approved in its current form due to the need for additional data demonstrating clinical benefit. Incyte plans to review the letter and coordinate with the FDA on next steps. The BLA submission was based on Phase 2 trial data.

Incyte has scheduled a conference call to discuss its Q2 2021 financial results at 8:00 a.m. ET on August 3, 2021. The press release will be issued at 7:00 a.m. ET on the same day. For those unable to attend, a thirty-day replay will be available via specific U.S. and international dial-in numbers. Incyte, based in Wilmington, Delaware, focuses on developing treatments for serious unmet medical needs.

Incyte announces positive results from the Phase 3 REACH3 study published in The New England Journal of Medicine, demonstrating that ruxolitinib significantly improves outcomes in patients with steroid-refractory chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT). Key findings include an overall response rate (ORR) of 49.7% versus 25.6% for BAT (P<0.001) and a best overall response (BOR) rate of 76.4% for ruxolitinib. The study indicates longer failure-free survival and improved self-reported symptoms. No new safety signals were observed. This data supports the company's supplemental New Drug Application to the FDA.

Incyte and MorphoSys announced a positive opinion from the European Medicines Agency’s CHMP recommending conditional marketing authorization for tafasitamab combined with lenalidomide for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who can't undergo autologous stem cell transplantation (ASCT). This follows the FDA's approval in July 2020. Tafasitamab represents a crucial treatment option for the 30-40% of DLBCL patients who face poor prognoses. The final decision by the European Commission is awaited, with expectations to commercialize tafasitamab as Minjuvi in the EU.

Incyte announced that the Oncologic Drugs Advisory Committee (ODAC) voted 13-4 to defer a regulatory decision on the Biologics License Application (BLA) for retifanlimab, a PD-1 inhibitor for treating advanced squamous cell carcinoma of the anal canal (SCAC) in patients intolerant to platinum-based chemotherapy. The ODAC's recommendation is based on the need for additional data from an ongoing clinical trial, POD1UM-303. Despite the setback, Incyte remains committed to collaborating with the FDA and highlights the urgent unmet need for treatments in this patient population.

Incyte announced multiple abstracts for ruxolitinib cream, a topical JAK1/JAK2 inhibitor, to be presented at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference on June 13, 2021. The data from the Phase 3 TRuE-AD program will provide insights into the cream's potential as a treatment for atopic dermatitis, a prevalent form of eczema. Key presentations will address long-term safety, disease control, and productivity impacts for patients. Ruxolitinib cream is currently in Phase 3 development for atopic dermatitis and vitiligo.

Incyte Corporation (Nasdaq:INCY) announced that the FDA has extended the review period for its New Drug Application (NDA) for ruxolitinib cream for treating atopic dermatitis by three months to September 21, 2021. This extension allows the FDA to review additional data provided by Incyte, considered a Major Amendment to the NDA. The company remains confident in the cream's potential as a safe treatment option and continues its collaboration with the FDA to expedite its availability to patients.

Incyte announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi^®) for treating steroid-refractory chronic graft-versus-host disease (GVHD) in patients aged 12 and older. The new PDUFA target date is September 22, 2021, allowing time for the FDA to review additional data submitted by Incyte. This amendment is considered a Major Amendment, resulting in a three-month extension. Incyte remains confident in the data from the REACH3 trial supporting the sNDA submission.