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REPL Stock Plunges 54% in 3 Months After FDA Rejects Skin Cancer Drug
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Key Takeaways
Replimune shares fell 54.2% in three months after the FDA issued a CRL against its RP1 BLA in July.
The FDA cited shortcomings in the IGNYTE study data but noted no safety concerns with RP1.
Replimune met with the FDA to discuss next steps, with a clear regulatory path still uncertain.
Replimune Group’s (REPL - Free Report) share price tumbled 54.2% over the past three months. The massive setback was observed after the FDA issued a complete response letter (CRL) in July, against the biologics license application (BLA) seeking accelerated approval for its lead pipeline asset, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) to treat adult patients with advanced melanoma.
The FDA stated 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 results were difficult to interpret due to the heterogeneity of the patient population and highlighted shortcomings in the ongoing confirmatory study’s design, particularly regarding the contribution of components. However, the FDA raised no safety concerns.
The setback has cast significant uncertainty on the regulatory path for RP1, which Replimune had positioned as a potential near-term growth driver in a high-need oncology market. It has also significantly delayed REPL’s prospects of bringing its first approved product to market, postponing the opportunity to establish a steady revenue stream. The sharp decline reflects both the near-term disruption to Replimune’s development timeline and broader investor concerns about the company’s ability to deliver on its lead program.
Year to date, shares of Replimune have crashed 64.2% against the industry’s 3.6% growth.
Image Source: Zacks Investment Research
Last week, Replimune announced that it has completed a Type A meeting with the FDA to discuss the CRL issued against the BLA for RP1 in combination with Bristol Myers’ Opdivo for advanced melanoma.
The company is currently reviewing the agency’s feedback to assess possible next steps, though a clear path forward under the accelerated approval pathway has yet to be identified. This also likely contributed to the stock price drop. Management emphasized the continued unmet need in advanced melanoma and plans to work closely with the FDA to determine a viable route for an expeditious path forward for RP1.
More on REPL's BLA for the RP1/Opdivo Combo
Replimune’s BLA for the RP1/Opdivo combo in advanced melanoma was accepted by the FDA for review under its Priority Review pathway in January 2025.
The BLA was based on the primary analysis data of the IGNYTE study, which evaluated RP1 in combination with Bristol Myers’ Opdivo for treating patients with anti-PD-1 failed melanoma, showing a favorable risk-benefit profile.
BMY’s blockbuster immuno-oncology drug Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a plethora of cancer indications in many countries, including the United States and the EU.
The FDA had previously granted a Breakthrough Therapy designation to RP1 in combination with Bristol Myers’ Opdivo for treating adult patients with advanced melanoma who have previously received an anti-PD1-containing regimen.
Apart from the melanoma indication, REPL is studying the combo therapy 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 also has a second candidate in its clinical-stage pipeline, which is currently being evaluated in two separate mid-stage studies for skin and liver cancer indications.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from $1.10 to $1.52 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.46 to $2.12. Year to date, shares of CRMD have surged 41.4%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 82.8% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.
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REPL Stock Plunges 54% in 3 Months After FDA Rejects Skin Cancer Drug
Key Takeaways
Replimune Group’s (REPL - Free Report) share price tumbled 54.2% over the past three months. The massive setback was observed after the FDA issued a complete response letter (CRL) in July, against the biologics license application (BLA) seeking accelerated approval for its lead pipeline asset, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) to treat adult patients with advanced melanoma.
The FDA stated 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 results were difficult to interpret due to the heterogeneity of the patient population and highlighted shortcomings in the ongoing confirmatory study’s design, particularly regarding the contribution of components. However, the FDA raised no safety concerns.
The setback has cast significant uncertainty on the regulatory path for RP1, which Replimune had positioned as a potential near-term growth driver in a high-need oncology market. It has also significantly delayed REPL’s prospects of bringing its first approved product to market, postponing the opportunity to establish a steady revenue stream. The sharp decline reflects both the near-term disruption to Replimune’s development timeline and broader investor concerns about the company’s ability to deliver on its lead program.
Year to date, shares of Replimune have crashed 64.2% against the industry’s 3.6% growth.
Image Source: Zacks Investment Research
Last week, Replimune announced that it has completed a Type A meeting with the FDA to discuss the CRL issued against the BLA for RP1 in combination with Bristol Myers’ Opdivo for advanced melanoma.
The company is currently reviewing the agency’s feedback to assess possible next steps, though a clear path forward under the accelerated approval pathway has yet to be identified. This also likely contributed to the stock price drop. Management emphasized the continued unmet need in advanced melanoma and plans to work closely with the FDA to determine a viable route for an expeditious path forward for RP1.
More on REPL's BLA for the RP1/Opdivo Combo
Replimune’s BLA for the RP1/Opdivo combo in advanced melanoma was accepted by the FDA for review under its Priority Review pathway in January 2025.
The BLA was based on the primary analysis data of the IGNYTE study, which evaluated RP1 in combination with Bristol Myers’ Opdivo for treating patients with anti-PD-1 failed melanoma, showing a favorable risk-benefit profile.
BMY’s blockbuster immuno-oncology drug Opdivo is approved, both as a monotherapy and in combination with Yervoy, to treat a plethora of cancer indications in many countries, including the United States and the EU.
The FDA had previously granted a Breakthrough Therapy designation to RP1 in combination with Bristol Myers’ Opdivo for treating adult patients with advanced melanoma who have previously received an anti-PD1-containing regimen.
Apart from the melanoma indication, REPL is studying the combo therapy 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 also has a second candidate in its clinical-stage pipeline, which is currently being evaluated in two separate mid-stage studies for skin and liver cancer indications.
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 CorMedix (CRMD - Free Report) and Kiniksa Pharmaceuticals (KNSA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from $1.10 to $1.52 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.46 to $2.12. Year to date, shares of CRMD have surged 41.4%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 82.8% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.