ROIV PDUFA Date: Brepocitinib Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target Sep 30, 2026 · Roivant Sciences Ltd. · Dermatomyositis (DM)
Key facts FDA PDUFA target date 2026-09-30
Drug / candidate Brepocitinib
Indication Dermatomyositis (DM)
Company Roivant Sciences Ltd.
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → All September 2026 PDUFA dates → FAQ When is the ROIV PDUFA date? The FDA PDUFA target date for ROIV (Roivant Sciences Ltd.) is 2026-09-30 for Brepocitinib. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is ROIV's drug Brepocitinib? Brepocitinib is Roivant Sciences Ltd.'s candidate under FDA review for Dermatomyositis (DM).
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