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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.
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Incyte will present at the 39th 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.
Eli Lilly and Incyte announced that the FDA granted an Emergency Use Authorization (EUA) for baricitinib in combination with remdesivir for hospitalized patients with COVID-19 requiring supplemental oxygen. This is the second Lilly therapy to receive EUA for COVID-19 treatments. In clinical trials, the combination showed a 12.5% reduction in recovery time and a 35% decrease in mortality compared to remdesivir alone. Despite this progress, the use remains temporary, pending further evaluation of baricitinib's efficacy and safety.
Incyte (Nasdaq: INCY) announced the presentation of over 40 abstracts related to its oncology portfolio at the 62nd American Society of Hematology Annual Meeting (ASH 2020) from December 5–8, 2020. Notable studies include the Phase 3 REACH3 study of ruxolitinib for chronic graft-versus-host disease and various presentations on myeloproliferative neoplasms. The company expressed gratitude for ASH's virtual format, emphasizing its commitment to addressing significant medical needs in oncology.
On November 2, 2020, Eli Lilly and Incyte announced positive long-term data for Olumiant (baricitinib) to be presented at ACR Convergence 2020. Key findings show that 27.5% of csDMARD-IR and 18.4% of bDMARD-IR patients achieved Low Disease Activity after 2.3 years. In a 5-year study, low rates of radiographic progression were maintained across various RA patient populations. No new safety concerns were identified, reinforcing Olumiant's long-term efficacy and safety for moderate to severe rheumatoid arthritis treatments.
Eli Lilly and Incyte announced new data for baricitinib presented at the 29th annual EADV Congress, showcasing its long-term efficacy in treating moderate to severe atopic dermatitis. In the BREEZE-AD3 Phase 3 study, over 40% of patients maintained clear skin after 68 weeks of treatment. Baricitinib received EU approval for adult patients who qualify for systemic therapy. The safety profile aligns with previous studies, reinforcing its potential role in managing this chronic condition ultimately impacting approximately 1-3% of adults worldwide.
Eli Lilly and Incyte presented data for baricitinib at the virtual Fall Clinical Dermatology meeting from Oct 29 to Nov 1, 2020. The Phase 2 study (BRAVE-AA1) evaluated its efficacy in adult patients with alopecia areata (AA). Results showed significant improvement in patients achieving a SALT score ≤20 at 36 weeks, with the 4-mg dose showing 51.9% improvement versus 3.6% for placebo (p=0.001). Following positive Phase 2 results, Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) have been initiated. The FDA has granted Breakthrough Therapy designation for baricitinib for AA due to unmet medical needs.
