Short answer
Replimune Group, Inc. (REPL) filed an 8-K current report with the SEC on April 13, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Standard Regulation FD disclaimer limiting Exchange Act Section 18 liability.
Replimune Group, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Standard Regulation FD disclaimer limiting Exchange Act Section 18 liability
- Disclosure not incorporated by reference into other SEC filings absent specific reference
Item 8.01 · Other Events
- FDA issued a second Complete Response Letter for RP1 plus nivolumab in advanced melanoma
- Regulatory setback delays potential approval and commercial launch of RP1
- Repeat rejection increases uncertainty around additional trial or resubmission requirements
Item EX-99.1 · Exhibit EX-99.1
- FDA complete response letter rejects RP1 plus nivolumab BLA for advanced melanoma, delaying potential commercialization
- IGNYTE showed 34% response rate and 24.8-month median response duration in anti-PD-1 progressed patients
- RP1 plus nivolumab delivered 30.6-month median progression-free survival versus 4.4 months on prior PD-1 therapy
- Replimune plans job eliminations and substantial U.S. manufacturing reductions, signaling immediate cost-cutting and execution risk
- Accelerated approval pathway remains uncertain despite ongoing Phase 3 IGNYTE-3 confirmatory trial
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
Other Replimune Group, Inc. 8-K filings
Get the next REPL 8-K as it lands
Follow REPL for push alerts, or ask the research agent what this filing means.