Incyte Corp - INCY STOCK NEWS

Incyte announced significant findings from its LIMBER trials at the ASH Annual Meeting. Phase 2 data revealed that adding parsaclisib to ruxolitinib (Jakafi^®) results in spleen volume reduction and symptom alleviation in patients with myelofibrosis (MF). Additionally, early results from a Phase 1/2 study indicated that INCB00928 safely improves anemia in MF patients. Both studies emphasize the need for alternative therapies for patients unresponsive to current treatments. The company continues to advance its clinical programs with additional Phase 3 trials underway.

Syndax Pharmaceuticals and Incyte announced promising results from the Phase 1/2 trial of axatilimab in patients with chronic graft-versus-host disease (cGVHD), showing an overall response rate (ORR) of 67% and ORR of 82% at 1 mg/kg every two weeks. The treatment demonstrated broad clinical benefits across multiple organ systems, with a 52% reduction in glucocorticoids for responding patients. Furthermore, axatilimab had a favorable safety profile, with 40% experiencing serious adverse events, yet no high-grade toxicities. Topline data from the AGAVE-201 study is expected mid-2023.

Incyte has announced a Collaboration and License Agreement with CMS Aesthetics for the development and commercialization of ruxolitinib cream in Greater China and parts of Southeast Asia. The agreement includes an upfront payment from CMS to Incyte, along with potential milestones and royalties based on sales. Ruxolitinib cream is already approved in the U.S. for treating autoimmune dermatological conditions like atopic dermatitis and vitiligo. This partnership aims to enhance treatment options in the targeted regions.

Incyte (Nasdaq:INCY) announced its participation in two upcoming investor conferences in November and December 2022. The company will present at the Evercore ISI HealthCONx Conference on November 29, 2022, at 12:35 pm (EST), and at the Bank of America Securities Biotech SMID Cap Conference on December 7, 2022, at 8:35 am (EST) in Boston. These presentations will be available via live webcast on Investor.Incyte.com and can be replayed for 30 days.

Incyte and Mirati Therapeutics have announced a collaboration to explore the efficacy of INCB99280, an oral PD-L1 inhibitor, in combination with adagrasib, a KRAS^G12C inhibitor, targeting patients with KRAS^G12C-mutated solid tumors. Incyte will sponsor a Phase 1/1b clinical trial assessing this combination, leveraging INCB99280's potential for improved management of immune-related adverse effects. This collaboration aligns with Mirati's strategy to investigate adagrasib across various combinations, aiming to enhance treatment options for hard-to-treat cancers.

Incyte announced the presentation of abstracts from its oncology pipeline at the SITC 37th Annual Meeting, scheduled from November 8-12, 2022, in Boston. Highlighted studies include Phase 1 research on PD-L1 inhibitors (INCB099280, INCB099318, INCB086550) and a bispecific antibody (INCA32459). Incyte aims to enhance treatment options for cancer patients. Additionally, they address potential risks and uncertainties related to clinical trials and regulatory approvals, emphasizing their ongoing commitment to oncology advancements.

Incyte will present key data from its oncology portfolio at the 64th American Society of Hematology Annual Meeting (ASH 2022) in New Orleans from December 10-13, 2022. Highlights include the plenary session featuring the novel anti-mutant CALR-targeted monoclonal antibody INCA033989 and results from its LIMBER studies evaluating combination therapies like ruxolitinib with parsaclisib. The company will also host an analyst event on December 11 to discuss these findings.

Incyte reported Q3 2022 net product revenues of $713 million, a 20% increase year-over-year, driven by strong performances from Jakafi and Opzelura. Jakafi generated $620 million (+13% Y/Y), prompting an upward revision of full-year guidance to $2.38 - $2.40 billion. Opzelura contributed $38 million and is expanding into vitiligo. The company is progressing in clinical trials, including promising results for povorcitinib in hidradenitis suppurativa. Operating expenses rose significantly, impacting net income, which fell to $112.8 million compared to $181.7 million in Q3 2021.

Incyte announced the publication of data from the Phase 3 TRuE-V clinical trial in The New England Journal of Medicine, demonstrating the effectiveness of ruxolitinib cream (Opzelura™) for treating nonsegmental vitiligo. The trials showed significant repigmentation, with approximately 30% of patients achieving ≥75% improvement in facial vitiligo at Week 24, rising to 50% by Week 52. The FDA recently approved Opzelura as the first and only treatment for this condition. These results highlight a major advancement in the management of vitiligo, impacting over 1.5 million individuals in the U.S.