On September 17, 2025, Roivant Sciences and Priovant Therapeutics announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). Brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo, with a statistically significant p-value of 0.0006. This marks the first positive outcome for a 52-week placebo-controlled trial and the first positive registrational trial for a targeted therapy in DM.
Brepocitinib demonstrated clinically meaningful and statistically significant improvement over placebo on all nine key secondary endpoints, including measures of skin disease, muscle disease, and steroid-sparing effects. Approximately 75% of patients entered the study on background steroids, and 62% of brepocitinib 30 mg patients achieved a steroid dose of ≤2.5 mg/day by Week 52, compared to 34% for placebo. Furthermore, 42% of brepocitinib 30 mg patients were able to fully eliminate oral corticosteroids, versus 23% for placebo.
The observed safety profile for brepocitinib 30 mg was consistent with previous clinical trials, with adverse events of special interest not occurring at a greater frequency than in the placebo arm. Priovant plans to file a New Drug Application (NDA) for brepocitinib in dermatomyositis in the first half of 2026. Dermatomyositis affects approximately 50,000 adults in the U.S., representing a significant market opportunity for this potential first-in-class oral therapy.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.