Roivant Sciences’ subsidiary Priovant Therapeutics reported that the Phase 3 VALOR trial of brepocitinib in dermatomyositis was published in the New England Journal of Medicine on March 28 2026. The study enrolled 241 patients across 90 sites and met its primary endpoint, showing a 15.3‑point greater improvement in mean Total Improvement Score at week 52 versus placebo (P < 0.001). The data also demonstrated significant steroid‑sparing effects, with nearly twice as many patients on the 30 mg dose reducing background corticosteroids compared with placebo.
The publication coincides with the U.S. Food and Drug Administration’s grant of Priority Review for brepocitinib’s New Drug Application, with a Prescription Drug User Fee Act target action date in the third quarter of 2026. The company expects a commercial launch in the United States by the end of September 2026, positioning the drug to fill a critical unmet need in a disease that currently has only one approved therapy.
Analysts project brepocitinib could reach $1 billion in sales by 2031 for the dermatomyositis indication, with peak global revenues of $2.7 billion by 2039. The trial results establish brepocitinib as the first targeted therapy for dermatomyositis, potentially creating a new market segment and providing a strong competitive advantage over the existing standard of care.
Safety data from the trial showed an increase in serious infections with the 30 mg dose compared with placebo, but most events resolved and the majority of patients completed treatment. Notably, malignancies, cardiovascular events, and thromboembolic events were more frequent in the placebo arm, underscoring the drug’s favorable safety profile relative to standard therapy.
The results strengthen Roivant’s commercial prospects and support its strategic shift from a pipeline‑focused company to a revenue‑generating entity. The positive data are expected to enhance investor confidence and may accelerate the drug’s path to FDA approval and market launch.
Analysts have responded to the trial by raising price targets for Roivant Sciences: H.C. Wainwright increased its target to $34, Goldman Sachs to $38, and Citi to $35, reflecting heightened expectations for brepocitinib’s commercial potential.
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