Incyte Genomics Inc - INCY STOCK NEWS

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.

Incyte and MorphoSys have initiated the Phase 3 inMIND study, with the first patient dosed, to evaluate the efficacy and safety of tafasitamab combined with lenalidomide and rituximab in treating relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL). The study aims to enroll over 600 patients, targeting improved progression-free survival. Despite advancements in treatment, a significant medical need remains for FL and MZL therapies, as these conditions constitute a large segment of non-Hodgkin lymphoma cases.

Incyte has scheduled its first quarter financial results conference call for May 4, 2021, at 8:00 a.m. ET. The press release will be made available at 7:00 a.m. ET on the same day. Interested parties can join the call via domestic dial-in at 877-407-3042 or international dial-in at 201-389-0864, using Conference ID 13718346. A replay of the call will be accessible for 30 days post-event. Investors can watch the live webcast with accompanying slides on Incyte's investor page and access the replay for 90 days.

Eli Lilly and Incyte reported on April 8, 2021, that the COV-BARRIER Phase 3 trial of baricitinib did not meet its primary endpoint of reducing mechanical ventilation or death by Day 28. Baricitinib showed a 2.7% lesser progression risk compared to placebo, which was not statistically significant. However, a significant 38% reduction in all-cause mortality was noted among baricitinib patients. The trial included 1,525 participants across various countries. Lilly plans to publish detailed findings and share them with regulatory authorities for further validation of baricitinib's efficacy in treating COVID-19.

Eli Lilly and Incyte announced that the FDA has extended the review period for the supplemental New Drug Application for baricitinib, intended for treating adults with moderate to severe atopic dermatitis. The new PDUFA action date is set for early Q3 2021, allowing further review of data analyses submitted by Lilly. Despite this delay, Lilly's financial guidance for 2021 remains unchanged. Baricitinib, an oral JAK inhibitor, is also being researched for other conditions, including COVID-19 and rheumatoid arthritis.