A look at the U.S. Food and Drug Administration’s drug approval review calendar.
Eli Lilly’s stock prices ticked up following the company’s announcement of strong quarterly sales and positive Phase III results in severe atopic dermatitis.
Incyte’s ruxolitinib cream hit the drug’s primary endpoint in the Phase III TRuE-AD2 trial of atopic dermatitis in adolescents and adults. Incyte and Eli Lilly announced topline results from the Phase III trial (FREEZE-AD4) of baricitinib in topical corticosteroids for the treatment of adults with moderate to severe atopic dermatitis who did not respond to treatment with cyclosporine.
AnaptysBio Inc. announced topline data from the clinical-stage biotechnology company’s ATLAS Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in 300 adults treated with etokimab in moderate-to-severe atopic dermatitis.
Singapore-based ASLAN Pharmaceuticals amended the company’s global license agreement with CSL Limited to gain full rights to the fully human monoclonal antibody ASLAN004 being developed for atopic dermatitis and other inflammatory diseases.
Pfizer Inc.’s experimental atopic dermatitis treatment abrocitinib met the main goals in a late-stage study that tested the drug in patients aged 12 and older with moderate to severe forms of the disease.
The U.S. Food and Drug Administration approved expanded use of Regeneron Pharmaceuticals Inc. and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17 years.
Eli Lilly and Company and Incyte Corporation announced that baricitinib met the primary endpoint in BREEZE-AD1 and BREEZE-AD2, two Phase 3 studies evaluating the efficacy and safety of baricitinib monotherapy for the treatment of adult patients with moderate to severe atopic dermatitis.
Realm Therapeutics opted to discontinue all drug development programs and is considering a potential sale of the Malvern, Pa.-based company following a clinical trial failure with the atopic dermatitis treatment PR022.
Aimmune Therapeutics said on Monday it would collaborate with Regeneron Pharmaceuticals and Sanofi to develop its experimental peanut allergy drug.