Monitor for advisory committee outcome in late July and PDUFA decision on August 2, 2026. A positive FDA decision would be transformative; negative outcome could pressure the stock.
Price Chart
Executive Summary
Replimune reported a fiscal Q4 2026 EPS miss of -$0.77 vs -$0.72 consensus, a -6.9% surprise, with no revenue. The highlight is FDA acceptance of the RP1 BLA resubmission with a PDUFA date of August 2, 2026, and an advisory committee expected in late July, representing a pivotal near-term catalyst.
Key Financial Metrics
Key Facts
- FDA accepted RP1 BLA resubmission for advanced melanoma; PDUFA date August 2, 2026
- Advisory committee meeting expected in late July 2026
- Fiscal Q4 2026 EPS -$0.77 vs consensus -$0.72 (miss of $0.05)
- Cash and equivalents $268.9M as of March 31, 2026; cash runway into Q1 2027
- Net loss for Q4 $73.7M, full year $313.9M
Financial Impact
BLA approval could unlock significant revenue potential; no current product revenue. Cash burn rate suggests need for future financing if approval delayed.
Risk Factors
- FDA non-approval or complete response letter for RP1
- Cash burn may require dilutive financing before profitability
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3318910 |
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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