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Fly News Breaks for February 13, 2020
INCY
Feb 13, 2020 | 11:26 EDT
Piper Sandler analyst Tyler Van Buren maintained an Overweight rating and $95 price target on Incyte (INCY) following the company's "good" Q4 earnings report, where the company reported better than expected revenues that drove cash earnings 61% higher year-over-year. Going forward, the analyst believes Jakafi, which the company guided 2020 sales modestly above the firm's expectations, is "underappreciated." He also believes the company's pemigatinib and capmatinib launch opportunities later this year are underappreciated.
News For INCY From the Last 2 Days
INCY
Mar 3, 2021 | 06:51 EST
Eli Lilly (LLY) and Incyte (INCY) announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata, or AA. Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received breakthrough therapy designation from the FDA for the treatment of AA. This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint. There are currently no FDA-approved treatments for AA. This multicenter, randomized, double-blind, placebo-controlled study included 546 adults with a Severity of Alopecia Tool, or SALT, score of 50 and a current episode of severe AA lasting at least six months but no more than eight years. The study included a diverse patient population from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S. Safety outcomes of baricitinib in BRAVE-AA2 were consistent with its established safety profile in patients with rheumatoid arthritis, or RA, and atopic dermatitis, or AD. No deaths, major adverse cardiovascular events, or MACE, or venous thromboembolic events, or VTEs, were reported in the study. BRAVE-AA2 is the first Phase 3 study with "positive" results in patients with AA. Data from an additional Phase 3 study of baricitinib in AA will be available in the first half of this year. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. AA is the second potential treatment indication in dermatology for baricitinib after AD. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as Olumiant in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. Baricitinib is also being investigated in systematic lupus erythematosus, juvenile idiopathic arthritis and COVID-19.