The U.S. Food and Drug Administration (FDA) has accepted Priovant Therapeutics' New Drug Application (NDA) for brepocitinib for the treatment of dermatomyositis (DM). The FDA has granted the NDA Priority Review, indicating that, if approved, brepocitinib could provide significant improvements in treating a serious condition. A Prescription Drug User Fee Act (PDUFA) target action date has been assigned for the third quarter of calendar year 2026. Priovant Therapeutics expects to launch brepocitinib in the United States at the end of September 2026, pending regulatory approval. The Priority Review designation was supported by the significant unmet medical need in dermatomyositis and positive results from the Phase 3 VALOR study. The VALOR study was the longest and largest interventional dermatomyositis trial to date, and the first-ever positive 52-week placebo-controlled study in DM.