INCY News & Events

Incyte announced final 24-week data from the Phase 3 TRuE-AD4 study evaluating the efficacy and safety of Opzelura cream in adults with moderate atopic dermatitis who had an inadequate response, intolerance or contraindication to topical corticosteroids and topical calcineurin inhibitors. These data were presented at the 2026 European Academy of Dermatology and Venereology Symposium. As previously reported, the TRuE-AD4 study met both of its co-primary endpoints at Week 8, with a statistically significantly higher proportion of patients on Opzelura versus vehicle cream achieving EASI75 and, separately, IGA-TS. Patients who achieved an EASI50 response at Week 8 continued double-blind treatment, as needed, through Week 24. Most patients in the Opzelura treatment group completed treatment through Week 24. Among those patients, 84.3% achieved EASI75 and 70.6% achieved IGA-TS at Week 24, similar to the frequencies at Week 8. Mean affected body surface area remained low and itch relief remained high with Opzelura treatment. As-needed treatment with Opzelura was well tolerated, with few application site reactions and no new safety signals up to 24 weeks. The most common treatment-emergent adverse events were upper respiratory tract infection and nasopharyngitis. "We are pleased to share these results, which demonstrate sustained disease control over 24 weeks in adults with moderate AD and further reinforce the well-tolerated safety profile of Opzelura," said Pablo Cagnoni, President and Global Head of Research and Development, Incyte. "We look forward to continuing to work with EU regulatory authorities to bring this differentiated, nonsteroidal treatment option to European adults with moderate AD who have progressed on standard topical therapies."

Incyte Corporation was granted FDA orphan designation for a treatment of pancreatic cancer, according to a post to the agency's website.

MacroGenics (MGNX) announced that it entered into an expanded royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of Zynyz. MacroGenics and Sagard entered into the initial Zynyz royalty purchase agreement in June 2025. Zynyz is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte (INCY) pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to Zynyz, including future potential development, regulatory and commercial milestones. Under the terms of the amended royalty purchase agreement, MacroGenics receives a $60M upfront payment from Sagard and is eligible to receive an additional 2026 sales-based milestone of up to $20M for the sale of its royalty rights on global net sales of Zynyz. All royalty rights will revert back to MacroGenics once Sagard has received total payments of either 1.7x its investment by September 30, 2032, or 2x its investment at any time thereafter.

Incyte announced that the U.S. Food and Drug Administration has approved Jakafi XR extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis; adults with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease or chronic GVHD after failure of one or two lines of systemic therapy. "The approval of Jakafi XR reinforces Incyte's leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD," said Bill Meury, Chief Executive Officer, Incyte. "Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice."