June 29, 2026

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Replimune Group, Inc. (NASDAQ: REPL) reported fiscal fourth-quarter and full-year 2026 results while providing an update on its lead oncolytic immunotherapy program, RP1, which is now back under FDA review for advanced melanoma.
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Replimune is a clinical-stage biotechnology company developing oncolytic immunotherapies designed to activate anti-tumor immune responses. Its pipeline includes RP1 and RP2, both engineered herpes simplex virus-based therapies being studied across advanced cancer settings.
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RP1 FDA Review Is the Main Catalyst

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Replimune recently announced that the FDA accepted its resubmitted Biologics License Application for RP1, also known as vusolimogene oderparepvec, in combination with nivolumab for advanced melanoma.
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The FDA classified the resubmission as a complete, class 1 response and set a goal date of August 2, 2026.
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The agency also notified Replimune that it expects to hold an advisory committee meeting in late July.
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That makes the next several weeks critical for the company, as investor attention shifts toward the advisory committee outcome and potential FDA decision.

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Clinical Programs Continued to Advance

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At ASCO 2026, Replimune presented three-year overall survival data from the IGNYTE trial of RP1 plus nivolumab in anti-PD-1-failed melanoma patients.
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The company reported that 47.8% of all treated patients were alive at three years, with median overall survival of 32.9 months. Among responders, the three-year survival rate was 83.5%.
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The confirmatory Phase 3 IGNYTE-3 trial of RP1 plus nivolumab is actively enrolling patients with advanced melanoma who progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment.
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Replimune also reported progress with RP2. Final Phase 1 data presented at ASCO showed a 19% objective response rate for RP2 as monotherapy and in combination with nivolumab across advanced solid tumor types.
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The registration-directed REVEAL Phase 2/3 trial of RP2 in metastatic uveal melanoma is actively enrolling. A Phase 2/3 transition is expected in the first quarter of 2027.

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Financial Results

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Replimune ended March 31, 2026, with $268.9 million in cash, cash equivalents, and short-term investments, down from $483.8 million a year earlier.
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The company said its existing cash position is expected to fund operations into the first quarter of calendar 2027. That includes preparation for potential RP1 commercialization in skin cancers and general corporate purposes, but excludes any potential revenue.
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Research and development expenses were $52.3 million for the fiscal fourth quarter and $221.2 million for the full year, compared with $54.0 million and $189.4 million, respectively, in fiscal 2025.
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Selling, general and administrative expenses were $21.0 million for the quarter and $98.7 million for the year, compared with $25.4 million and $72.2 million a year earlier.
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Net loss was $73.7 million for the fiscal fourth quarter and $313.9 million for the full fiscal year, compared with $74.1 million and $247.3 million in fiscal 2025.

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The Bigger Picture

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Replimune is entering a major regulatory window.
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The company’s financial results show continued heavy spending as it prepares for a possible RP1 approval and advances multiple oncology trials. The more important near-term story is the FDA review. A favorable advisory committee outcome and potential approval could shift Replimune from a clinical-stage biotech into a commercial-stage oncology company.
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The risk is timing and capital. Replimune has cash runway into early 2027, but continued trial spending and commercialization preparation make the RP1 decision especially important.
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