Shares of Replimune Group REPL soared 85.7% on Friday after the company announced that it had aligned with the FDA on the resubmission of the biologics license application (BLA) for its lead pipeline asset, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ BMY Opdivo (nivolumab) for treating advanced melanoma, following productive discussions with the regulatory body.
The company is planning to resubmit the BLA for the RP1 combo in the upcoming days.
Upon receipt, the FDA plans to treat the BLA resubmission as an urgent matter and prioritize its review, acknowledging the significant unmet medical need in advanced melanoma.
The BLA was based on data from the IGNYTE study, which evaluated RP1 plus Opdivo in advanced melanoma patients with confirmed progression on an anti-PD-1-containing regimen.
Bristol Myers’ blockbuster immuno-oncology drug Opdivo is approved across multiple tumor types, including lung, melanoma and kidney cancers. BMY recorded $2.15 billion in Opdivo sales in the first quarter of 2026, down 5% year over year.
REPL’s Price Performance
Year to date, shares of Replimune have decreased 10.6% against the industry’s rise of 1%.
Image Source: Zacks Investment Research
REPL’s Previous Hurdle With RP1 BLA
In April 2026, the FDA issued a second complete response letter CRL to Replimune’s resubmitted BLA for RP1 in combination with BMY’s Opdivo in advanced melanoma. The first CRL against the RP1 BLA for the melanoma indication was issued in July 2025 by the agency.
Back then, the FDA noted that data from the IGNYTE study, submitted in support of the application, failed to meet its standards for an adequate and well-controlled clinical investigation, preventing approval of the BLA in its current form. The agency noted that the IGNYTE study data were difficult to interpret due to heterogeneity in the patient population and highlighted shortcomings in the ongoing confirmatory study’s design, particularly regarding the contributions of components. However, the FDA raised no safety concerns.
However, Replimune pushed back against the FDA’s second CRL for its resubmitted BLA for RP1 combo in advanced melanoma, arguing that the dataset supporting the therapy remains adequate for accelerated approval. Back then, the company also highlighted broader implications of the FDA’s decision, noting that the lack of regulatory flexibility could delay access to a potentially beneficial therapy for patients with limited treatment options.
It can be inferred that the CRLs dealt a significant setback to Replimune’s plans to launch its first commercial product, delaying the prospect of generating a stable revenue stream.
Besides melanoma, Replimune is studying the RP1 plus Opdivo combo in a separate cohort of the IGNYTE study for several non-melanoma skin cancer indications. The company is also evaluating RP1 as a monotherapy in solid organ transplant recipients with skin cancers.
Replimune Group, Inc. Price
Replimune Group, Inc. price | Replimune Group, Inc. Quote
REPL Zacks Rank & Stocks to Consider
Replimune presently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the drug/biotech sector are Immunocore IMCR 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, 2026 estimates for Immunocore have moved from a loss of 88 cents per share to earnings of 6 cents, while estimates for 2027 earnings per share have risen from 24 cents to 87 cents during the same time. IMCR stock has lost 16.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 79.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
Radical New Technology Could Hand Investors Huge Gains
Quantum Computing is the next technological revolution, and it could be even more advanced than AI.
While some believed the technology was years away, it is already present and moving fast. Large hyperscalers, such as Microsoft, Google, Amazon, Oracle, and even Meta and Tesla, are scrambling to integrate quantum computing into their infrastructure.
Senior Stock Strategist Kevin Cook reveals 7 carefully selected stocks poised to dominate the quantum computing landscape in his report, Beyond AI: The Quantum Leap in Computing Power .
Kevin was among the early experts who recognized NVIDIA's enormous potential back in 2016. Now, he has keyed in on what could be "the next big thing" in quantum computing supremacy. Today, you have a rare chance to position your portfolio at the forefront of this opportunity.
See Top Quantum Stocks Now >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Bristol Myers Squibb Company (BMY): Free Stock Analysis Report
Replimune Group, Inc. (REPL): Free Stock Analysis Report
Liquidia Corporation (LQDA): Free Stock Analysis Report
Immunocore Holdings PLC Sponsored ADR (IMCR): Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).