Roivant Sciences Ltd. (ROIV) and its subsidiary Priovant Therapeutics Wednesday announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM), an idiopathic inflammatory condition characterized by debilitating muscle weakness and skin lesions. Following the news, Roivant shares were more than 11% up in pre-market.
In the VALOR study, brepocitinib demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint. At week 52, brepocitinib achieved a mean Total Improvement Score (TIS) of 46.5 versus 31.2 for placebo. A statistically significant difference between brepocitinib and placebo was observed at all time points, including as early as week 4. Additionally, brepocitinib demonstrated a safety profile consistent with that observed in previous clinical trials.
Priovant plans to file a New Drug Application for brepocitinib in dermatomyositis in the first half of 2026.
Roivant stock had closed at $14.18, up 1.65% on Tuesday. It has traded in the range of $8.73 - $14.48 in the last 1 year.
For comments and feedback contact: editorial@rttnews.com
Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.