(RTTNews) - Priovant Therapeutics, a subsidiary of Roivant Sciences Ltd. (ROIV), on Tuesday said the U.S. Food and Drug Administration has accepted its new drug application for brepocitinib and granted it priority review for the treatment of dermatomyositis.
The FDA assigned a Prescription Drug User Fee Act target action date in the third quarter of calendar year 2026.
The company noted that the priority review designation was supported by the significant unmet medical need in dermatomyositis and positive results from the Phase 3 VALOR study evaluating brepocitinib in the disease.
The company expects to launch the drug in the United States at the end of September 2026.
Roivant shares closed at $28.10 on Monday, down 2.9%.
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