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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 announced promising 52-week results from its pivotal Phase 3 TRuE-V clinical trials for ruxolitinib cream (Opzelura), targeting nonsegmental vitiligo in patients aged 12 and older. Key findings presented at the 2022 AAD Annual Meeting indicate that approximately 50% of patients achieved ≥75% improvement in facial Vitiligo Area Scoring Index at Week 52. Safety data showed no significant adverse reactions. These results further support the therapeutic potential of ruxolitinib cream, with FDA review expected by July 18, 2022.
Incyte announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of ruxolitinib (Jakavi) for treating acute and chronic graft-versus-host disease (GVHD) in patients aged 12 and older with inadequate responses to corticosteroids. This recommendation is based on successful Phase 3 REACH2 and REACH3 trials showing improved response rates of 62.3% and 49.7% for ruxolitinib compared to best available therapy. The European Commission is expected to make a final decision within two months.
Incyte announced the presentation of new data on ruxolitinib cream (Opzelura) for vitiligo and atopic dermatitis at the American Academy of Dermatology Annual Meeting from March 25-29, 2022, in Boston. The highlight includes 52-week results of the Phase 3 TRuE-V vitiligo program, demonstrating the cream's safety and efficacy in patients aged 12 and older. Incyte aims to emphasize its commitment to dermatological treatments through multiple Phase 3 studies during the event.
Incyte Corporation announced the extension of the FDA review period for the supplemental New Drug Application (sNDA) for ruxolitinib cream (Opzelura) intended for vitiligo treatment. The PDUFA action date is now set for July 18, 2022, allowing additional time to review data from ongoing Phase 3 studies. The TRuE-V trial program assesses the cream's safety and efficacy on over 600 patients aged 12 and older. Incyte aims to provide a vital treatment option as current therapies for repigmentation in vitiligo are lacking in the U.S.
Incyte will present at the Cowen 42nd Annual Health Care Conference on March 7, 2022, at 9:50 a.m. ET. The presentation will be available via live webcast at Investor.Incyte.com and can be replayed for 30 days. Headquartered in Wilmington, Delaware, Incyte is dedicated to developing solutions for serious unmet medical needs through its proprietary therapeutics. For further information, visit Incyte.com.
Incyte reported Q4 2021 revenues of $862.9 million, up 9% year-over-year, with total product and royalty revenues of $813 million (+20%) and Jakafi revenues of $592 million (+15%). The company projects Jakafi revenues of $2.3 to $2.4 billion for 2022. Incyte successfully launched Opzelura in atopic dermatitis, treating nearly 19,000 patients by year-end. The FDA has accepted a supplemental application for Opzelura in vitiligo, with a decision expected by April 18, 2022. The company ended 2021 with $2.3 billion in cash and marketable securities.
Incyte will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 11:20 a.m. ET. The event will be held virtually, and the presentation will be accessible via a live webcast on Investor.Incyte.com, with a replay available for 30 days. Incyte, based in Wilmington, Delaware, focuses on developing proprietary therapeutics to address serious medical needs. For more information, visit Incyte.com.
Eli Lilly and Incyte provided updates on the Phase 3 development for OLUMIANT (baricitinib) in systemic lupus erythematosus (SLE) and atopic dermatitis. The Phase 3 lupus program has been discontinued after the SLE-BRAVE-I study met its primary endpoint, while SLE-BRAVE-II did not. Ongoing discussions with the FDA may lead to a Complete Response Letter for the atopic dermatitis sNDA due to lack of alignment on the indicated population. Lilly remains committed to other research with OLUMIANT, including potential regulatory approvals for COVID-19 and alopecia areata in 2022.
Incyte announced the withdrawal of its New Drug Application (NDA) for parsaclisib in the U.S. for treating relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma. This decision follows discussions with the FDA on confirmatory studies that could not be completed in a timely manner. Additionally, Incyte has opted out of the continued development of MCLA-145, but will maintain collaboration with Merus. Parsaclisib remains in ongoing Phase 2 and Phase 3 trials for other indications.
Incyte has set a conference call for its Q4 and year-end 2021 financial results at 8:00 a.m. ET on February 8, 2022. The corresponding press release will be issued earlier that day at 7:00 a.m. ET. Investors can access the live webcast at Investor.Incyte.com. A replay will be available for 90 days post-event. Incyte, based in Wilmington, Delaware, focuses on developing therapeutics to address unmet medical needs.
