Incyte Corp - INCY STOCK NEWS

Incyte announced the FDA's acceptance of its New Drug Application (NDA) for parsaclisib, a next-generation oral inhibitor, to treat relapsed/refractory follicular, marginal zone, and mantle cell lymphomas. The FDA granted Priority Review for marginal zone and mantle cell cases, with a target decision date of April 30, 2022. The NDA for follicular lymphoma has a Standard Review status and a target date of August 30, 2022. Parsaclisib showcased a manageable safety profile in Phase 2 studies, highlighting its potential in addressing significant unmet medical needs.

Incyte announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for ruxolitinib cream as a treatment for non-segmental vitiligo in adolescents and adults. This validation signifies that the MAA is now ready for formal review. The application is backed by data from the Phase 3 TRuE-V clinical trials, which involved over 600 participants and demonstrated significant improvements in skin repigmentation. Ruxolitinib cream is also approved for mild to moderate atopic dermatitis in the U.S.

Incyte has scheduled its Q3 2021 financial results conference call for 8:00 a.m. ET on November 2, 2021. The related press release will be available at 7:00 a.m. ET on the same day. Investors can access the live webcast at Investor.Incyte.com, which will remain available for 90 days. For those unable to attend, a replay will be available via dial-in numbers provided, using conference ID 13724199. This session is crucial for stakeholders to assess the company's performance and future outlook.

Incyte has announced the results from its pivotal Phase 3 TRuE-V clinical trial for ruxolitinib cream (Opzelura™) in patients aged 12 and above with nonsegmental vitiligo. After 24 weeks, 29.9% of patients showed ≥75% improvement in the facial Vitiligo Area Scoring Index (F-VASI75). More than 51% achieved ≥50% improvement in F-VASI. The overall safety profile remained consistent, with no severe treatment-related adverse events reported. Incyte plans to submit marketing applications to the FDA and EMA by the end of 2021.

Eli Lilly and Incyte announced significant results from two pivotal Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) for OLUMIANT (baricitinib) in treating severe alopecia areata. The once-daily 4-mg dose demonstrated superior scalp hair regrowth compared to placebo, with 35.2% of patients achieving over 80% scalp coverage at 36 weeks. The 2-mg dose also showed notable improvements. OLUMIANT has received Breakthrough Therapy designation from the FDA, and a supplemental New Drug Application is planned. The drug has an established safety profile with manageable side effects, underscoring its potential in addressing this unmet medical need.

Incyte has appointed Dr. Otis Brawley to its Board of Directors, effective September 27, 2021. Dr. Brawley brings extensive clinical experience, having served at Johns Hopkins University and the American Cancer Society. His appointment is expected to enhance the board's capabilities in advancing scientific discovery and developing innovative medicines. CEO Hervé Hoppenot expressed confidence in Dr. Brawley's contributions to the company's future success.

Syndax Pharmaceuticals and Incyte announced a global collaboration to develop axatilimab, an anti-CSF-1R monoclonal antibody, focusing on chronic graft-versus-host disease (cGVHD) and idiopathic pulmonary fibrosis (IPF). Syndax will receive $117 million upfront and $35 million in equity investment, along with potential milestone payments of up to $450 million. The companies will share profits in the U.S. 50:50, with Syndax receiving double-digit royalties internationally. Ongoing trials for axatilimab aim to provide innovative treatments for patients with severe conditions, with topline data expected in 2023.

Incyte announced that the FDA approved Jakafi (ruxolitinib) for treating chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy in patients aged 12 and older. This marks Jakafi's fourth FDA-approved indication, following its approval for steroid-refractory acute GVHD in 2019. The approval is based on the REACH3 trial, which showed a 49.7% overall response rate for Jakafi versus 25.6% for best available therapy at Week 24. Chronic GVHD affects over 14,000 patients in the U.S.

Incyte announced FDA approval for Opzelura (ruxolitinib) cream, the first topical JAK inhibitor for treating mild to moderate atopic dermatitis (AD) in patients aged 12 and older. Approval was based on the TRuE-AD clinical trial, where nearly 54% of patients achieved significant treatment success at week 8. Common side effects include nasopharyngitis and diarrhea. Over 21 million Americans suffer from AD, highlighting the market potential of Opzelura. The company plans to support patients through the IncyteCARES program and recently scheduled an investor conference call for September 22, 2021.