Incyte Corp Stock Price, News & Analysis

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.

MorphoSys US Inc. and Incyte announced new three-year follow-up data from the Phase 2 L-MIND study of tafasitamab in combination with lenalidomide for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

The study included 80 patients and showed an overall response rate (ORR) of 57.5% and a complete response (CR) rate of 40%. The median duration of response (DoR) was 43.9 months with median overall survival (OS) at 33.5 months.

Results were presented at the 2021 ASCO Annual Meeting and indicate potential long-term disease control for difficult-to-treat DLBCL patients.

Incyte and MorphoSys US Inc. announced new three-year follow-up data from the Phase 2 L-MIND study of tafasitamab (Monjuvi) combined with lenalidomide for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Of 81 patients, 80 were evaluated, showing an overall response rate of 57.5% and a complete response rate of 40%. Median progression-free survival was 11.6 months, and overall survival was 33.5 months. Tafasitamab was FDA-approved in July 2020 for DLBCL patients not eligible for autologous stem cell transplant, demonstrating significant long-term efficacy.

Eli Lilly and Incyte presented data at the EULAR Congress indicating that OLUMIANT® (baricitinib) 4 mg significantly reduced pain and morning joint stiffness while enhancing physical function at 12 weeks in moderate to severe rheumatoid arthritis patients compared to HUMIRA® (adalimumab) and placebo. The analysis, based on the Phase 3 RA-BEAM study with 1,305 participants, highlighted improved patient-reported outcomes and consistent safety results. OLUMIANT is approved in over 75 countries for RA treatment and recently received approval in Japan for COVID-19 pneumonia.