Incyte Genomics Inc - INCY STOCK NEWS

Incyte announced positive topline results from its pivotal Phase 3 TRuE-V clinical trial program for ruxolitinib cream in patients with vitiligo. Both TRuE-V1 and TRuE-V2 studies met the primary endpoint, showing a significant improvement in facial vitiligo scoring (p<0.0001) with 1.5% ruxolitinib cream applied twice daily. Secondary endpoints also showed favorable patient outcomes. The company plans to submit marketing applications to the FDA and EMA in H2 2021. Ruxolitinib cream could become the first approved treatment for vitiligo, addressing a significant unmet medical need.

Incyte (Nasdaq:INCY) announced that its oncology portfolio data will be presented at the EHA 2021 Virtual Congress from June 9-17, 2021. Highlights include the first presentation of Phase 2 study data for parsaclisib in autoimmune hemolytic anemia and real-world data on ruxolitinib. Key abstracts cover studies on ponatinib, ruxolitinib, and combination trials with parsaclisib, emphasizing Incyte's commitment to addressing significant unmet medical needs in oncology.

Incyte and MorphoSys have commenced the pivotal Phase 3 frontMIND trial, dosing the first patient to evaluate a combination treatment of tafasitamab and lenalidomide with R-CHOP for high-risk diffuse large B-cell lymphoma (DLBCL) patients. DLBCL affects about 30,000 individuals annually in the U.S., with a significant unmet need as current treatments yield poor outcomes for high-risk groups. The study aims to enroll 880 patients, focusing on progression-free survival and overall response rates. These efforts follow encouraging preliminary results from previous trials.

Incyte reports Q1 2021 financial results and a positive outlook despite softer demand for Jakafi due to COVID-19. CEO Hervé Hoppenot highlighted a return to pre-pandemic patient levels and potential launches for new treatments, including ruxolitinib for chronic GVHD and ongoing trials for tafasitamab. The FDA has accepted the sNDA for ruxolitinib in GVHD with a PDUFA date of June 22, 2021. Incyte anticipates multiple regulatory approvals and trial initiations this year, reinforcing its growth strategy.

Incyte announced the presentation of multiple abstracts on ruxolitinib cream at the Society for Investigative Dermatology Virtual Meeting 2021. The cream, a JAK1/JAK2 inhibitor, targets atopic dermatitis (AD), impacting patient quality of life. Key abstracts include studies on the cream's efficacy in reducing skin pain, achieving an itch-free state, and treating patients with atopic comorbidities. Ruxolitinib cream is in Phase 3 development for AD and vitiligo, with worldwide rights retained by Incyte. Presentations are available on-demand until May 31, 2021.

Incyte announced its participation in the Bank of America Securities Virtual 2021 Healthcare Conference, scheduled for May 13, 2021, at 12:30 p.m. ET. The presentation will be accessible via live webcast on Investor.Incyte.com and will be available for replay for a duration of 90 days. Incyte, headquartered in Wilmington, Delaware, is a global biopharmaceutical company dedicated to addressing serious unmet medical needs through innovative therapeutics.

Recent analyses from the BREEZE-AD5 Phase 3 clinical trial reveal that Eli Lilly and Incyte's OLUMIANT (baricitinib) 2-mg tablet significantly improves treatment outcomes for adults with moderate to severe atopic dermatitis (AD). The data shows remarkable early improvements in symptom severity and quality of life, with over 50% improvement in Eczema Area and Severity Index (EASI) scores at four weeks. An extended safety analysis across eight studies indicates no increased risk of serious adverse events. Results were presented at the AAD Virtual Meeting from April 23-25, 2021.

Incyte announced findings from pooled analyses of its Phase 3 studies, TRuE-AD1 and TRuE-AD2, on ruxolitinib cream for atopic dermatitis. Results showed significant improvements in therapeutic efficacy across various patient profiles. Ruxolitinib cream 0.75% and 1.5% applied twice daily outperformed the vehicle control in multiple endpoints including the Investigator’s Global Assessment and itch scores. The overall safety profile remained consistent with previous studies. These findings were presented at the American Academy of Dermatology Virtual Meeting Experience 2021, enhancing the evidence for ruxolitinib as a viable treatment option for atopic dermatitis.

Incyte announced positive findings from two analyses of its Phase 2 study on ruxolitinib cream for vitiligo, presented at the AAD VMX. The study met its primary endpoint, with significant improvement in facial vitiligo scoring after 24 weeks. At 104 weeks, improved repigmentation persisted, showing that 83.6% of patients achieved F-VASI50. The safety profile was consistent with prior data. These results highlight the potential for ruxolitinib cream in treating vitiligo, a condition with no FDA-approved therapies, paving the way for Phase 3 studies later this year.