Roivant Sciences(US:ROIV)2025-09-17 12:00VALOR Study Topline Results - The VALOR study of Brepocitinib in Dermatomyositis (DM) succeeded with highly significant, robust, and consistent data across primary and all key secondary endpoints[18] - A consistent dose response was observed between 15 mg and 30 mg, establishing 30 mg as the optimal dose[18] - Brepocitinib 30 mg showed a mean TIS of 46.5, a delta of >15 points (p=0.0006) relative to placebo at week 52 (TIS of 31.2)[18] - Over two-thirds (68%) of brepocitinib 30 mg patients experienced at least a moderate response (TIS40), compared to 44.3% on placebo[37,61] - Nearly half (46.1%) of brepocitinib 30 mg patients experienced a major response (TIS60), compared to 26.4% on placebo[37,61] - Median time to a TIS40 response was approximately 2 months[18] - At week 52, 54.3% of patients achieving TIS40 Response + ≤2.5 mg OCS on Brepocitinib 30mg vs 26.6% on Placebo[61] - At week 52, CDASI-A change from baseline at -11.7 for Brepocitinib 30mg vs -7.0 for Placebo[61] Safety and Regulatory - The safety profile of Brepocitinib 30 mg in VALOR was consistent with prior clinical studies[18] - FDA filing is planned for the first half of 2026[18]