# REPL PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/REPL
Company: Replimune Group

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with REPL.

## REPL PDUFA Milestones

- 2025-07-22 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for RP1 (vusolimogene oderparepvec) + nivolumab on July...
  Company: Replimune Group
  Source: https://www.globenewswire.com/news-release/2025/07/22/3119299/0/en/Replimune-Receives-Complete-Response-Letter-from-FDA-for-RP1-Biologics-License-Application-for-the-Treatment-of-Advanced-Melanoma.html
  Event detail: https://biopharmsignal.com/pdufa-calendar/REPL/rp1-vusolimogene-oderparepvec-nivolumab-rp1-melanoma-bla-review-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/july (July 2025)
- 2026-04-10 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for RP1 (vusolimogene oderparepvec) + nivolumab on April...
  Company: Replimune Group
  Source: https://www.sec.gov/Archives/edgar/data/1737953/000110465926042141/tm2611633d1_8k.htm
  Event detail: https://biopharmsignal.com/pdufa-calendar/REPL/rp1-vusolimogene-oderparepvec-nivolumab-rp1-melanoma-bla-review-2.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/april (April 2026)
- 2026-08-02 — PDUFA — FDA granted accelerated approval to TUDRIQEV plus nivolumab. FDA granted accelerated approval for TUDRIQEV in combination with nivolumab for adults with unre...
  Company: Replimune Group
  Source: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm
  Event detail: https://biopharmsignal.com/pdufa-calendar/REPL/rp1-nivolumab-advanced-melanoma-review-3.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/august (August 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/REPL
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the REPL PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with REPL, including decision dates, application stage, and summary details when available.
### Where can I find more context for REPL?

Use the BioPharmSignal company page for REPL to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.