Incyte Genomics Inc - INCY STOCK NEWS

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.

Incyte's Pemazyre^® (pemigatinib) has received approval from the European Commission for treating adults with advanced cholangiocarcinoma exhibiting FGFR2 fusions or rearrangements. This marks the first new treatment for this patient group in over ten years, addressing a critical unmet need. The decision is based on data from the FIGHT-202 study, which showed a 37% overall response rate and an 8-month median duration of response in eligible patients. Incyte aims to ensure rapid patient access across Europe following this significant milestone.

Incyte has received approval from Japan's Ministry of Health for Pemazyre® (pemigatinib), targeting patients with unresectable biliary tract cancer (BTC) featuring FGFR2 fusion genes, following chemotherapy failure. This milestone underscores Incyte's commitment to addressing unmet medical needs. The approval stems from the FIGHT-202 study, where Pemazyre showed a 36% overall response rate in patients with FGFR2 fusions. Notably, the Japanese market has designated this as an orphan drug, facilitating quicker access for rare disease treatments.

Incyte announced results from the Phase 3 DEVENT study assessing ruxolitinib's efficacy in COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). The study did not meet its primary endpoint for overall mortality reduction. However, significant improvements in mortality were noted in the U.S. patient population for both 5mg and 15mg ruxolitinib doses compared to placebo. The safety profile was consistent with existing data. Incyte plans to provide ruxolitinib at no cost to eligible patients through an Expanded Access Program, subject to FDA agreement.

Incyte (Nasdaq: INCY) will present multiple abstracts at the AACR Annual Meeting 2021, showcasing clinical and pre-clinical data from its oncology portfolio. Key highlights include data on INCB106385, an A2A/A2B receptor antagonist, and INCA00186, a CD73 monoclonal antibody. Other presentations will focus on the LIMBER development program, especially a Phase 2 study combining ruxolitinib and parsaclisib for myelofibrosis. All sessions will be available on demand from April 10, 2021, through June 21, 2021.