The upcoming AdCom in late July and PDUFA date on August 2 are the primary catalysts. Approval of RP1 would mark Replimune's first commercial product. Monitor for any FDA briefing documents or panel recommendations ahead of the AdCom.
Price Chart
Executive Summary
Replimune reported fiscal Q4 2026 results with net loss of $73.7M, in line with expectations for a pre-revenue biotech. The key catalyst is the FDA's acceptance of the RP1 BLA resubmission with a PDUFA goal date of August 2, 2026, and an advisory committee meeting scheduled for late July. Cash of $268.9M supports operations into early calendar 2027.
Key Facts
- FDA accepted RP1 BLA resubmission as a complete, class 1 response with PDUFA date August 2, 2026.
- Advisory committee meeting expected in late July 2026.
- Cash, cash equivalents and short-term investments were $268.9M as of March 31, 2026.
- Net loss for Q4 fiscal 2026 was $73.7M, full year net loss $313.9M.
- Cash runway extends into early calendar 2027, excluding potential revenue.
Financial Impact
No revenue; net loss increased to $73.7M for the quarter (from $74.1M a year ago). Cash burn rate consistent with R&D and pre-commercial scale-up.
Risk Factors
- FDA may not approve RP1, or may require additional data.
- Competition from other oncolytic virus therapies and checkpoint inhibitors.
- Cash runway limited; may need financing before revenue materializes.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001104659-26-078511 |
| Document: tm2619129d1_8k.htm | 0001104659-26-078511 |
| Document: 0001104659-26-078511-index-headers.html | 0001104659-26-078511 |
| Document: 0001104659-26-078511-index.html | 0001104659-26-078511 |
| Document: 0001104659-26-078511.txt | 0001104659-26-078511 |
| 8-K Data (Synthetic) | 0001104659-26-078511 |
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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