Roivant and Priovant announced a successful Phase 3 trial for brepocitinib, a TYK2/JAK1 inhibitor, in dermatomyositis. The drug demonstrated significant symptom reduction over placebo in a 52-week study involving 241 patients. Plans are underway to file for FDA approval in early 2026. Brepocitinib, initially developed by Pfizer and licensed to Roivant, represents the first targeted therapy to succeed registrational testing in this rare autoimmune muscle and skin disorder. The 30 mg dose also enabled more patients to reduce or eliminate steroid use without cardiovascular complications, aligning with safety profiles observed in past trials.