REPL
RP1 (vusolimogene oderparepvec) + nivolumab
FDA PDUFA Target Action Date · Replimune Group, Inc.
Sunday, August 2, 2026
25 days away
Drug Information
- Application Type
- BLA (Class 1 resubmission)
- FDA Designations
- BreakthroughPriority Review
- Indication
- Advanced melanoma (progressed on anti-PD-1 containing regimen)
Filing Details
- Company
- Replimune Group, Inc.
- Stock Ticker
- REPL
- SEC CIK
- 0001737953
- Source
- SEC 8-K →
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: 2026-06-29. Report an issue