FDA Grants Priority Review For Priovant's Brepocitinib For Dermatomyositis
(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%.
Founded in the late 1990s by Andrew Mariathasan in New York, with the goal of covering Wall Street for a new generation of investors, RTTNews has expanded steadily over the years to become a trusted provider of content for a wide array of subjects across several platforms. RTT's Financial Newswire is relied upon by some of the world's largest financial institutions, including banks, brokerages, trading platforms and financial exchanges.