Incyte Genomics Inc - INCY STOCK NEWS

Incyte has announced the FDA approval of Opzelura (ruxolitinib) cream 1.5%, the first and only topical treatment for nonsegmental vitiligo in patients aged 12 and older. Based on Phase 3 TRuE-V clinical trials, approximately 30% of patients achieved significant improvements in facial repigmentation at Week 24, increasing to 50% by Week 52. Opzelura is significantly impactful as it addresses a major unmet medical need, with potential for broad market appeal. An investor conference call is scheduled for July 19, 2022.

Incyte has scheduled its Q2 2022 financial results conference call for August 2, 2022, at 8:00 a.m. ET. The press release detailing these results will be available earlier on the same day at 7:00 a.m. ET. Investors can dial in using the domestic number 877-407-3042 or international number 201-389-0864, with the conference ID 13731520. A replay will be available for thirty days. Interested parties can also access the live webcast with slides via Incyte's investor website.

Eli Lilly and Incyte announced that the FDA has approved OLUMIANT (baricitinib) as the first systemic treatment for adults with severe alopecia areata. Available in 1 mg, 2 mg, and 4 mg doses, OLUMIANT has shown promising results in clinical trials, with 32-35% of patients achieving over 80% scalp coverage. The approval follows the BRAVE-AA1 and BRAVE-AA2 trials, involving 1,200 patients. While the treatment offers hope for patients, it comes with serious risks, including infections and cardiovascular events. Manufacturers are also working on patient access programs to help with costs.

Pfizer, MorphoSys, and Incyte announced a clinical trial collaboration to explore the immunotherapeutic combination of Pfizer's TTI-622 with MorphoSys's Monjuvi and lenalidomide for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not eligible for autologous stem cell transplantation. Pfizer will lead a multicenter Phase 1b/2 study, which is set to take place in North America, Europe, and Asia-Pacific. The initiative addresses significant unmet medical needs in DLBCL treatment and follows promising preclinical data regarding TTI-622's potential efficacy.

Incyte announced that multiple abstracts from its oncology portfolio will be presented at the European Hematology Association Congress 2022, taking place from June 9-17 in Vienna and virtually. Key studies include long-term efficacy results of Parsaclisib for autoimmune hemolytic anemia, and evaluations of Ruxolitinib for various hematological conditions. All ePoster presentations will be available on-demand beginning June 10. Incyte remains committed to addressing serious unmet medical needs, particularly in cancer treatment.

Incyte (Nasdaq:INCY) will present at the 43rd Annual Goldman Sachs Global Healthcare Conference on June 14, 2022, at 8:00 a.m. PDT / 11:00 a.m. EDT in Rancho Palos Verdes. The presentation will be available via a live webcast on the company's investor website, with a replay accessible for 30 days. Incyte is a Wilmington, Delaware-based biopharmaceutical company committed to developing proprietary therapeutics to address serious unmet medical needs.

Eli Lilly and Incyte announced a positive opinion from the European Medicines Agency's CHMP for OLUMIANT (baricitinib) to treat adults with severe alopecia areata. This opinion signals the potential for the first oral treatment and JAK inhibitor for severe alopecia areata in the EU, pending final approval from the European Commission, expected in the next 1-2 months. The judgment is based on the successful Phase 3 BRAVE-AA1 and BRAVE-AA2 trials, involving 1,200 patients, showing significant efficacy compared to placebo. The FDA has granted priority review for the same indication in the U.S.

The FDA has approved OLUMIANT (baricitinib), marking it as the first and only JAK inhibitor authorized for treating hospitalized adults with COVID-19 requiring oxygen support. Recommended dosing is 4 mg once daily for up to 14 days. This approval is based on positive results from Phase 3 studies ACTT-2 and COV-BARRIER, where OLUMIANT showed effectiveness without new safety concerns. Approximately one million patients have already received OLUMIANT globally since its emergency use in November 2020. Caution is advised due to risks of serious infections and other severe adverse events.

Incyte announced that the European Commission has approved Jakavi (ruxolitinib) for patients aged 12 and older with steroid-refractory acute or chronic graft-versus-host disease (GVHD). This marks the first approved treatment in Europe for this condition after inadequate steroid response. Clinical trials showed Jakavi's superiority over best available therapy, achieving an overall response rate of 62% versus 39% for acute GVHD, and 50% versus 26% for chronic GVHD. The approval follows a positive opinion from the EMA in March 2022, based on the results of the Phase 3 REACH2 and REACH3 studies.