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Incyte Corporation (INCY) is a global biopharmaceutical leader focused on innovative therapies in oncology, dermatology, and immunology. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's clinical developments, regulatory milestones, and strategic initiatives.
Access authoritative information about FDA approvals, clinical trial results, and research collaborations that shape Incyte's pipeline of small-molecule therapies. Our curated collection includes earnings announcements, partnership disclosures, and scientific advancements across therapeutic areas of focus.
Stay informed about developments in blood cancer treatments, autoimmune disorder therapies, and dermatological innovations through verified press releases and objective reporting. This resource serves as your primary source for tracking Incyte's progress in addressing unmet medical needs through targeted therapeutic solutions.
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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.
Incyte announced its participation in several investor conferences throughout June 2021. Key events include the William Blair 41st Annual Growth Stock Conference on June 3, the BioPharma Sustainability Roundtable’s CEO Investor Forum on June 7, the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, and Guggenheim’s series on June 28. These presentations will be available for live webcast and replay at Investor.Incyte.com.
Incyte is a biopharmaceutical company focused on addressing unmet medical needs through innovative therapeutics.
Incyte (Nasdaq: INCY) announced multiple abstracts showcasing data from its oncology portfolio to be presented at the 2021 ASCO Annual Meeting held from June 4-8, 2021. Key highlights include three-year data from the L-MIND study of tafasitamab and results from the OPTIC study of ponatinib. Key abstracts cover various studies including the use of ponatinib in leukemia, tafasitamab for lymphoma, and capmatinib for non-small cell lung cancer. The company remains committed to addressing serious medical needs through innovative therapies.
Incyte announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program for ruxolitinib cream in patients with vitiligo. Both TRuE-V1 and TRuE-V2 studies met the primary endpoint, showing a significant improvement in facial vitiligo scoring (p<0.0001) with 1.5% ruxolitinib cream applied twice daily. Secondary endpoints also showed favorable patient outcomes. The company plans to submit marketing applications to the FDA and EMA in H2 2021. Ruxolitinib cream could become the first approved treatment for vitiligo, addressing a significant unmet medical need.
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