Appointed
Michael Goller
member of the Board
REPL ·
Replimune Group, Inc.
appointed Michael Goller to the Board, effective immediately.
Ready 8-Ks
26
Latest filing
May 29, 2026, 9:56 AM ET
Top materiality
0.95
Event mix
other_material ×9 · regulatory ×8 · earnings ×8
Sentiment
11 pos · 5 neg · 10 neu
Latest earnings
reported 2026-Q3
Executive change
recent →
Recent 8-K filings for REPL
Highest-materiality recent filing
FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back
- FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.
- Without timely accelerated approval, further development of RP1 not viable; company eliminating jobs and scaling back U.S. manufacturing.
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Replimune to resubmit RP1 BLA for advanced melanoma; FDA agrees to prioritize review
Company will resubmit BLA in coming days after collaborative FDA dialogue aligns on path forward.
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FDA issues second CRL for Replimune's RP1 BLA; company plans layoffs and manufacturing scale-back
FDA second Complete Response Letter for BLA of RP1 plus nivolumab for advanced melanoma; Replimune disagrees with decision.
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Replimune Q3 net loss $70.9M; cash $269.1M; RP1 BLA PDUFA date April 10, 2026
Cash, cash equivalents, and short-term investments $269.1M as of Dec 31, 2025; cash runway extended late into Q1 2027.
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Replimune reports Q2 net loss $83.1M; FDA accepts RP1 BLA resubmission with PDUFA April 10, 2026
Cash, equivalents and investments $323.6M at Sep 30, 2025, down from $483.8M at Mar 31, 2025.
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FDA accepts Replimune's BLA resubmission for RP1 in advanced melanoma; PDUFA April 10, 2026
FDA accepted resubmission of BLA for RP1 plus nivolumab in advanced melanoma patients who progressed on anti-PD-1 therapy.
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Replimune completes Type A FDA meeting for RP1 BLA in melanoma; path forward uncertain
Completed Type A FDA meeting on Sept 16, 2025 regarding CRL for RP1+nivolumab BLA in advanced melanoma.
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Replimune schedules Type A meeting with FDA to discuss RP1 CRL; program viability at risk
FDA Type A meeting scheduled to discuss CRL for RP1 BLA in advanced melanoma; briefing submitted with additional analysis.
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Replimune reports Q1 FY2026 net loss $86.7M; FDA issues CRL for RP1 BLA
Net loss of $86.7M for quarter ended June 30, 2025, vs $53.8M a year ago.
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Replimune receives FDA Complete Response Letter for RP1 BLA in advanced melanoma
FDA issues CRL for RP1 + nivolumab; IGNYTE trial deemed not adequate/well-controlled.
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Replimune Q4 net loss $74.1M; RP1 BLA on track for July 22 PDUFA
Net loss Q4 $74.1M, FY $247.3M; cash $483.8M, runway into Q4 2026 excluding revenue.
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Replimune Q3 net loss $66.3M; FDA accepts RP1 BLA with priority review, PDUFA July 22
FDA accepted BLA for RP1+nivolumab in advanced melanoma with Priority Review; PDUFA date July 22, 2025.
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FDA accepted BLA for RP1 (vusolimogene oderparepvec) plus nivolumab for advanced melanoma; granted Priority Review.
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Replimune closes $155.8M public offering of stock and pre-funded warrants
Offering of 6,923,000 common shares at $13.00 and 3,846,184 pre-funded warrants at $12.9999 each, raising ~$155.8M net.
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Replimune prices upsized public offering of ~$140M; 6.9M shares + pre-funded warrants
Offering includes 6,923,000 common shares at $13.00/share and pre-funded warrants for 3,846,184 shares at $12.9999 each.
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BLA submitted to FDA for RP1 (vusolimogene oderparepvec) + nivolumab in advanced melanoma patients previously treated with anti-PD1.
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Replimune reports Q2 FY2025 net loss $53.1M; BLA for RP1 in melanoma on track before year-end
Completed pre-BLA meeting with FDA; BLA submission for RP1+nivolumab in anti-PD1 failed melanoma via accelerated approval path on track by end of 2024.
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Replimune Q1 FY2025: $53.8M net loss, $469.1M cash; RP1 BLA on track for 2H 2024
Net loss $53.8M for Q1 ended June 30, 2024, up from $49.6M YoY; R&D expenses $43.0M versus $40.4M.
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Replimune raises $100M in PIPE to fund RP1 commercialization; BLA filing on track for 2H 2024
Issued 5.67M shares at $8.82/share and 5.67M pre-funded warrants at $8.819/warrant.
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Primary analysis shows ORR 33.6% (modified RECIST 1.1) and 32.9% (RECIST 1.1) by independent central review; all responses >6 months, median DOR >35 months.
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Replimune presents positive RP1/RP2 data at ASCO: 32.7% ORR in melanoma, BLA on track for 2H 2024
RP1+nivolumab in anti-PD-1 failed melanoma (n=156) showed 32.7% ORR by investigator; median duration of response >36 months.
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Replimune posts Q4 net loss $55.1M; RP1 melanoma BLA on track for 2H 2024
Net loss of $55.1M for Q4 FY2024; full-year net loss $215.8M vs $174.3M prior year.
Executive changes
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.95 · Median 0.75 · Most common event other_material