RP1 (vusolimogene oderparepvec) + nivolumab
FDA PDUFA Target Action Date · Replimune Group, Inc.
Note: CRL confirmed on the PDUFA date itself. This was Replimune's SECOND CRL for RP1 (the first was July 2025); the 2026-04-10 action date came from the Class 2 BLA resubmission the FDA accepted in October 2025. Verified from SEC EDGAR (CIK 0001737953): 8-K accession 0001104659-26-042141, event date 2026-04-10, filed 2026-04-13, carrying both Item 7.01 and Item 8.01 disclosure plus the April 10, 2026 press release as Exhibit 99.1 (https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_ex99-1.htm). CEO Sushil Patel disputed the decision and announced job cuts, saying "without timely accelerated approval, the development of RP1 will not be viable." No approval, no brand name. Source: https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_8k.htm
Drug Information
- Application Type
- BLA (Class II resubmission)
- FDA Designations
- BreakthroughPriority Review
- Indication
- Advanced melanoma (progressed on anti-PD-1 containing regimen)
- Approved As
- RP1 (vusolimogene oderparepvec) + nivolumab
Filing Details
- Company
- Replimune Group, Inc.
- Stock Ticker
- REPL
- SEC CIK
- 0001737953
- Source
- Company IR →
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: 2026-04-10. Report an issue