Roivant Sciences (ROIV) and Priovant Therapeutics said Wednesday that a phase 3 study of brepocitinib to treat dermatomyositis showed a "clinically meaningful and statistically significant improvement," compared with placebo on the primary endpoint and all nine key secondary endpoints.

The observed safety profile of a 30-milligram dose was consistent with previous brepocitinib clinical trials, the companies said. Priovant intends to file a new drug application for brepocitinib in dermatomyositis in H1 2026.

Dermatomyositis is a multi-organ idiopathic inflammatory condition that is characterized by debilitating muscle weakness and skin lesions.

Roivant shares were up 9.2% in recent premarket activity.