The advisory committee vote today is the key catalyst. A positive vote would likely lead to accelerated approval and significant stock upside; a negative vote would be a major setback. Monitor the vote outcome and FDA decision timeline.
Price Chart
Executive Summary
Replimune presented its BLA resubmission for RP1 (vusolimogene oderparepvec, TUDRIQEV) in combination with nivolumab to the FDA advisory committee for advanced melanoma. The IGNYTE Phase 2 data showed a 33.6% ORR (16.4% CR), median DOR of 24.8 months, and a 3-year OS rate of 47.8% with a manageable safety profile. The FDA's initial clinical review had already recommended accelerated approval, making today's advisory committee vote a pivotal catalyst for the stock.
Key Facts
- IGNYTE Phase 2 ORR: 33.6% (95% CI: 25.8, 42) with 16.4% complete response rate
- Median duration of response: 24.8 months (95% CI: 14.8, NE)
- 3-year overall survival rate: 47.8% (median OS 32.9 months)
- No treatment-related Grade 5 adverse events; mainly Grade 1-2 toxicities
- FDA clinical review (July 2025) recommended accelerated approval, citing substantial evidence of effectiveness
- Advisory committee meeting held July 30, 2026; outcome will influence FDA decision
Financial Impact
No financial data in filing; potential approval would be transformative for pre-revenue biotech with $454M market cap
Risk Factors
- Advisory committee may vote against approval despite positive FDA review
- FDA is not bound by committee vote and could still reject
- Confirmatory trial (IGNYTE-3) OS data not expected until 2030, leaving accelerated approval subject to post-market verification
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-088481 |
| Document: tm2621663d1_8k.htm | 0001104659-26-088481 |
| Document: 0001104659-26-088481-index-headers.html | 0001104659-26-088481 |
| Document: 0001104659-26-088481-index.html | 0001104659-26-088481 |
| Document: 0001104659-26-088481.txt | 0001104659-26-088481 |
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
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