Incyte Corp Stock Price, News & Analysis

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.

Incyte announced the presentation of multiple abstracts from its dermatology portfolio at the American Academy of Dermatology Virtual Meeting Experience from April 23-25, 2021. Key topics include new findings from the Phase 3 TRuE-AD clinical trial on ruxolitinib cream for atopic dermatitis and 104-week data from a Phase 2 study for vitiligo. The company aims to enhance understanding and treatment options for these chronic conditions, with a focus on the efficacy and safety of ruxolitinib cream.

Eli Lilly and Incyte announced successful results from the Phase 3 trials BRAVE-AA1 and BRAVE-AA2, evaluating baricitinib for severe alopecia areata. Both trials showed significant hair regrowth improvement in patients treated with 2-mg and 4-mg doses compared to placebo.

At Week 36, 35% of patients on 4-mg achieved at least 80% scalp hair coverage, while 22% on 2-mg did the same, leading to plans for a supplemental New Drug Application to the FDA in late 2021. Baricitinib, already approved for RA, may become the first approved treatment for this autoimmune disease.