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.
Price Chart
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.
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3303918 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 21, 2026 5w ago | Press Release | $14.71 $13.07 | ▲ +11.15% | ▲ +11.16% | $13.04 (+11.35%) |
Aug 19, 2026 6w ago | Insider Cluster | $14.05 $13.07 | ▼ −6.98% | ▼ −6.98% | $13.04 (−7.19%) |
Aug 14, 2026 7w ago | 8-K | $14.97 $13.11 | ▼ −12.42% | ▼ −10.43% | $13.04 (−12.89%) |
Aug 14, 2026 7w ago | Press Release | $14.97 $13.11 | ▼ −12.42% | ▼ −10.43% | $13.04 (−12.89%) |
Aug 12, 2026 7w ago | Insider Cluster | $15.19 $12.92 | ▼ −14.94% | ▼ −13.20% | $13.04 (−14.15%) |
Aug 12, 2026 7w ago | Insider Cluster | $15.19 $12.92 | ▼ −14.94% | ▼ −13.20% | $13.04 (−14.15%) |
Aug 10, 2026 7w ago | Press Release | $13.67 $14.77 | ▼ −8.05% | ▼ −8.96% | $13.04 (+4.61%) |
Aug 10, 2026 7w ago | 8-K | $13.67 $14.77 | ▼ −8.05% | ▼ −8.96% | $13.04 (+4.61%) |
Aug 10, 2026 7w ago | 424B5 | $13.67 $14.77 | ▼ −8.05% | ▼ −8.96% | $13.04 (+4.61%) |
Aug 7, 2026 8w ago | 8-K | $12.06 $15.04 | ▲ +24.71% | ▲ +25.11% | $13.04 (+8.13%) |
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