Shares of Replimune Group REPL have surged nearly 223% over the past three months, as the company steadily advanced its lead oncolytic immunotherapy, RP1 (vusolimogene oderparepvec), toward regulatory approval and strengthened the broader pipeline. The rally has been driven primarily by a series of positive regulatory developments that substantially reduced uncertainty surrounding RP1’s path to commercialization.
FDA Approves REPL’s RP1 for Advanced Melanoma
Earlier this month, the FDA granted accelerated approval to RP1 (vusolimogene oderparepvec) under the brand name Tudriqev, in combination with Bristol Myers’ BMY Opdivo (nivolumab) for the treatment of adults with unresectable advanced cutaneous melanoma whose disease has progressed following an anti-PD-1 antibody-based regimen.
Bristol Myers’ blockbuster immuno-oncology drug Opdivo is approved across multiple tumor types, including lung, melanoma and kidney cancers.
The FDA approval marks a major commercial milestone for Replimune as Tudriqev is the company’s first approved product.
Year to date, Replimune's shares have risen 24.1% compared with the industry’s 6.3% growth.
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The accelerated approval was supported by data from the IGNYTE study, in which the Tudriqev-Opdivo combination demonstrated clinically meaningful antitumor activity, including a significant objective response rate and durable responses in patients with advanced melanoma who had previously progressed on anti-PD-1 therapy. Continued approval of Tudriqev is contingent upon verification of clinical benefit in confirmatory studies.
The approval follows a lengthy regulatory process. In July 2025, the FDA issued its first complete response letter (CRL) for Replimune’s biologics license application (BLA) seeking approval of Tudriqev/Opdivo combination for advanced melanoma. The company subsequently resubmitted the BLA, but in April, the FDA issued a second CRL, concluding that the available data were insufficient to establish substantial evidence of effectiveness. Replimune disagreed with the agency’s assessment and maintained that the IGNYTE dataset was adequate to support accelerated approval.
In June, the FDA accepted Replimune’s resubmitted BLA for priority review as a complete Class 1 response and set a target action date of Aug. 2, 2026.
A key regulatory catalyst came in July, when the FDA’s cellular, tissue and gene therapies advisory committee reviewed the Tudriqev application. The committee voted 10-3 that the IGNYTE efficacy data were evaluable and clinically meaningful, providing important external validation of the clinical evidence supporting the drug and strengthening expectations for a favorable regulatory outcome.
Replimune’s Broader Pipeline
Beyond melanoma, Replimune is evaluating RP1 as a monotherapy in solid organ transplant recipients with skin cancers.
Replimune’s pipeline has a second oncolytic immunotherapy candidate, RP2, which is currently being evaluated in two separate studies for the treatment of metastatic uveal melanoma and hepatocellular carcinoma.
Replimune Group, Inc. Price and Consensus
Replimune Group, Inc. price-consensus-chart | Replimune Group, Inc. Quote
REPL’s Zacks Rank & Stocks to Consider
Replimune currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, earnings per share estimates for Harmony Biosciences have increased from $3.20 to $3.62 for 2026. Over the same period, estimates for earnings per share increased from $3.64 to $4.07 for 2027. HRMY shares have risen 2.6% year to date.
Harmony Biosciences missed on earnings in three of the trailing four quarters and beat in the remaining one, delivering an average negative surprise of 13.97%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 161.6% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
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Replimune Group, Inc. (REPL): Free Stock Analysis Report
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This article originally published on Zacks Investment Research (zacks.com).