REPL Replimune, Inc.
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Executive Summary
Replimune presented final Phase 1 data for RP2 (alone and with nivolumab) at ASCO 2026, showing durable responses in heavily pretreated advanced solid tumors, including a 33.3% ORR in uveal melanoma. The data support an ongoing randomized Phase 2/3 trial in uveal melanoma, but the filing is a clinical-stage update without regulatory approval or financial results, making it a notable but non-definitive catalyst.
Actionable Insight
The data de-risk RP2 in uveal melanoma, a high-unmet-need indication with a 33.3% ORR and durable responses. Monitor enrollment updates and interim data from the ongoing Phase 2/3 trial (NCT06581406). The stock may re-rate on positive regulatory milestones, but no BLA or NDA is imminent.
Key Facts
- Phase 1 FIH study enrolled 85 heavily pretreated patients (median 2 prior lines; 42% prior ICI therapy).
- RP2 monotherapy ORR: 19.0% (4/21 evaluable); RP2 + nivolumab ORR: 19.1% (9/47 evaluable).
- Pooled ORR in uveal melanoma (where Phase 2/3 is enrolling): 33.3%.
- Median duration of response not reached in monotherapy (range 11.5–27.3+ months); 22.1 months in combination (range 2.8–35.2+ months).
- Tumor regression observed in both injected and non-injected lesions, indicating systemic immune response.
- No Grade 4 or 5 treatment-related adverse events; safety profile consistent with immune activation.
- Randomized Phase 2/3 trial in metastatic uveal melanoma (NCT06581406) is enrolling.
Financial Impact
No financial data provided; clinical-stage company with no approved products or revenue.
Risk Factors
- Phase 2/3 trial may fail to replicate Phase 1 efficacy in a larger, randomized setting.
- Competition from other oncolytic virus therapies and ICI combinations.
- No near-term revenue or regulatory filing catalyst; cash burn risk for clinical-stage biotech.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303918 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
2d ago
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Institutional Cluster
| $8.46 awaiting T+5 | awaiting T+5 | — | $8.88 (−4.96%) |
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May 31, 2026
13d ago
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Press Release
| $9.00 $9.47 | ▲ +5.22% | ▲ +7.97% | $8.88 (−1.33%) |
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May 30, 2026
14d ago
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Press Release
| $9.00 $9.47 | ▲ +5.22% | ▲ +7.97% | $8.88 (−1.33%) |
|
May 29, 2026
15d ago
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8-K
| $8.69 $9.98 | ▲ +14.84% | ▲ +15.14% | $8.88 (+2.19%) |
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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
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