New England Journal of Medicine Publishes Positive Phase 3 VALOR Trial Results of Brepocitinib in Dermatomyositis

• The results of the Phase 3 VALOR trial were published in the New England Journal of Medicine, underscoring the practice-changing potential of brepocitinib 30 mg once-daily in dermatomyositis
• Brepocitinib 30 mg was superior to placebo on the primary and all nine key secondary endpoints, with statistically significant and clinically meaningful improvements observed across measures of global disease activity, muscle strength, skin disease, physical function, and corticosteroid reduction
• Additional analyses from VALOR, presented at the 2026 American Academy of Dermatology (AAD) Meeting, demonstrated meaningful improvements in itch and skin-related quality of life with brepocitinib 30 mg
• The U.S. Food and Drug Administration has granted Priority Review to brepocitinib’s New Drug Application (NDA) and assigned a Prescription Drug User Fee Act (PDUFA) target action date in the third quarter of 2026

DURHAM, N.C., March 28, 2026 (GLOBE NEWSWIRE) -- Priovant Therapeutics, a clinical-stage biotechnology company focused on developing targeted therapeutics in autoimmune disease, announced today the publication of results from the Phase 3 VALOR trial evaluating brepocitinib in adults with dermatomyositis (DM) in the New England Journal of Medicine (NEJM).

As reported in the NEJM publication, “A Phase 3 Trial of Brepocitinib in Dermatomyositis,” VALOR enrolled 241 patients across 90 sites globally and met its primary endpoint, with brepocitinib 30 mg achieving a 15.3-point greater improvement in mean Total Improvement Score (TIS) at Week 52 compared to placebo (P