REPL Replimune, Inc.
Price Chart
Executive Summary
Replimune presented 3-year landmark overall survival data from the IGNYTE trial of RP1 plus nivolumab in anti-PD-1-failed melanoma at ASCO 2026. The data showed a median overall survival of 32.9 months, with 47.8% of all treated patients alive at 3 years and 83.5% of responders alive at 3 years. This is a highly positive clinical data readout for a clinical-stage biotech with a single lead asset, providing strong evidence of durable benefit in a difficult-to-treat population.
Actionable Insight
The 3-year survival data strongly de-risks RP1's regulatory path in anti-PD-1-failed melanoma, a setting with limited options. Traders should watch for FDA BLA acceptance and potential priority review, which could drive further upside. The data also supports expansion into earlier lines and combination trials.
Key Facts
- Median overall survival (mOS) of 32.9 months in anti-PD-1-failed advanced melanoma patients treated with RP1 plus nivolumab.
- 47.8% of all treated patients alive at 3 years; 83.5% of responders alive at 3 years.
- Objective response rate (ORR) of 33.6% with median duration of response (DOR) of 24.8 months; 44.8% of responders maintained response at 3 years.
- Favorable safety profile with no Grade 5 events and no new safety signals over long-term follow-up.
- Data presented at ASCO 2026 oral session (Abstract 9518).
Financial Impact
Transformative for a clinical-stage biotech with a single lead asset; positive survival data in a high-need indication could support BLA approval and significant commercial upside.
Risk Factors
- BLA review outcome remains uncertain; FDA may request additional data or raise concerns.
- Competition from other oncolytic viruses and combination immunotherapies could limit market share.
- Clinical-stage company with no approved products; cash burn and dilution risk remain.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303875 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
|
Jun 11, 2026
2d ago
|
Institutional Cluster
| $8.46 awaiting T+5 | awaiting T+5 | — | $8.88 (−4.96%) |
|
May 31, 2026
13d ago
|
Press Release
| $9.00 $9.47 | ▲ +5.22% | ▲ +7.97% | $8.88 (−1.33%) |
|
May 30, 2026
14d ago
|
Press Release
| $9.00 $9.47 | ▲ +5.22% | ▲ +7.97% | $8.88 (−1.33%) |
|
May 29, 2026
15d ago
|
8-K
| $8.69 $9.98 | ▲ +14.84% | ▲ +15.14% | $8.88 (+2.19%) |
|
May 29, 2026
15d ago
|
Press Release
| $8.69 $9.98 | ▲ +14.84% | ▲ +15.14% | $8.88 (+2.19%) |
|
May 20, 2026
23d ago
|
Insider Cluster
| $5.22 $8.69 | ▲ +66.48% | ▲ +64.63% | $8.88 (+70.11%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access