ROIV
Brepocitinib
FDA PDUFA Target Action Date · Roivant Sciences Ltd.
Wednesday, September 30, 2026
10 days away
Note: Filed by Priovant (a Roivant company). Exact date not disclosed - Q3 2026 estimated as Sep 30 [DATE UNVERIFIED 2026-08-02: Exact day is NOT company-disclosed. Roivant Sciences' FY2026 Form 10-K (fiscal year ended Mar 31, 2026, filed 2026-05-20) states: 'Priovant's filing for use of ]
Drug Information
- Drug Name
- Brepocitinib (CT.gov)
- Application Type
- NDA
- FDA Designations
- BreakthroughOrphan DrugPriority Review
- Indication
- Dermatomyositis
Filing Details
- Company
- Roivant Sciences Ltd.
- Stock Ticker
- ROIV
- SEC CIK
- 0001635088
- Source
- GlobeNewswire →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue