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REPL Stock Soars on Plans of BLA Resubmission for Melanoma Combo Drug
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Key Takeaways
REPL shares soared 85.7% after FDA alignment on RP1 plus Opdivo BLA resubmission plans.
Replimune plans to resubmit the BLA in the coming days. The FDA intends to prioritize review.
The RP1 plus Opdivo BLA filing is based on results from the IGNYTE study in advanced melanoma.
Shares of Replimune Group (REPL - Free Report) 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 - Free Report) 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.
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%.
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REPL Stock Soars on Plans of BLA Resubmission for Melanoma Combo Drug
Key Takeaways
Shares of Replimune Group (REPL - Free Report) 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 - Free Report) 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 - Free Report) and Liquidia Corporation (LQDA - Free Report) , 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%.