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Priovant Announces FDA Acceptance and Priority Review of New Drug Application for Brepocitinib in Dermatomyositis

Roivant (ROIV)RoivantFDA / regulatory

FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositis If approved, brepocitinib would

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Roivant

Vant Operating Model Roivant develops and commercializes medicines through focused subsidiaries known as Vants. The structure gives individual programs dedicated teams while retaining access to the parent company's capital, development and commercialization capabilities. Brepocitinib Autoimmune Franchise Brepocitinib is an oral JAK1/TYK2...

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