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ROIV PDUFA Date: Brepocitinib

FDA decision (PDUFA) target 2026-09-30 · Roivant Sciences Ltd. · Dermatomyositis (DM)

ROIV run-up into the PDUFA (last ~120 days)

$32.41$26.41
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-30
Drug / candidateBrepocitinib
IndicationDermatomyositis (DM)
CompanyRoivant Sciences Ltd.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.gov—

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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).
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.