Roivant/Priovant: Phase 3 VALOR brepocitinib meets primary endpoint in dermatomyositis; NDA filing 1H 2026

Roivant Sciences Ltd.

Brepocitinib 30 mg achieved week-52 mean TIS 46.5 vs placebo 31.2 (p=0.0006); all 9 key secondary endpoints met.
62% of brepocitinib patients on background steroids achieved steroid dose ≤2.5 mg/day vs 34% placebo; 42% off steroids vs 23%.
Safety profile consistent with prior brepocitinib trials; no increase in AESIs in active arm vs placebo.
NDA submission for brepocitinib in dermatomyositis planned for calendar first half 2026.

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