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Home › PDUFA Calendar › ROIV

ROIV PDUFA Date: Brepocitinib

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on August 27, 2026.
FDA decision Approved August 27, 2026 · Roivant Sciences Ltd. · Dermatomyositis (DM)
More Immunology & Inflammation FDA decisions →

The story

Brepocitinib was approved by the FDA on August 27, 2026 to treat Dermatomyositis (DM).
Full PDUFA calendar ->Every upcoming FDA decision date, by monthARQT . 2026-06-29Same area: Immunology / Dermatology . ZORYVE (roflumilast) Cream 0.3%PFE-brepocitinib . 2026-09-30Same area: Immunology / Dermatology . BrepocitinibTLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

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 decisionApproved August 27, 2026
Drug / candidateBrepocitinib
IndicationDermatomyositis (DM)
CompanyRoivant Sciences Ltd.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNot listed

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FAQ

What did the FDA decide on ROIV's Brepocitinib?
The FDA decided ROIV's (Roivant Sciences Ltd.) application for Brepocitinib on August 27, 2026: Approved. We do not state a goal date for this application: the date we had carried was never sourced to a filing or company release. Verify against the linked primary source.
What is ROIV's drug Brepocitinib?
Brepocitinib is Roivant Sciences Ltd.'s drug, approved by the FDA on August 27, 2026 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% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · large-cap cohortn=790 · median +0.0% · 50% up
under -30%: 2 of 790 (0%)<-30-30 to -15%: 2 of 790 (0%)-15 to -7%: 6 of 790 (1%)-7 to -3%: 29 of 790 (4%)-3 to +3%: 707 of 790 (89%)±3+3 to +7%: 35 of 790 (4%)+7 to +15%: 5 of 790 (1%)+15 to +30%: 2 of 790 (0%)over +30%: 2 of 790 (0%)>+30
Distribution of next-day % moves after the FDA decision for large-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.