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Here's Why Replimune Stock Skyrockets Nearly 131% in 3 Months
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Key Takeaways
REPL gained on FDA acceptance of its resubmitted BLA for RP1 with Opdivo in advanced melanoma.
FDA confirmed the resubmission addresses prior CRL issues, with a final approval decision due April 10, 2026.
Replimune reported a 44% response rate and 11.9-month median response in acral melanoma from the IGNYTE study.
Shares of Replimune Group (REPL - Free Report) have surged 131.1% over the past three months, fueled by positive regulatory updates.
In October, the FDA accepted the resubmission of the biologics license application (BLA) seeking approval for REPL’s lead pipeline candidate RP1, in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab), for the treatment of advanced melanoma.
The regulatory body has set a target action date of April 10, 2026.
The BLA resubmission follows a complete response letter (CRL) issued in July 2025, in which the FDA cited concerns regarding data heterogeneity in the IGNYTE study population.
The regulatory body also stated that the IGNYTE study is not considered an adequate and well-controlled clinical investigation capable of providing substantial evidence of effectiveness.
The CRL further noted that certain aspects of the confirmatory trial’s study design require clarification, including the contribution of individual components. Additionally, no safety concerns were raised in the letter.
Since then, Replimune has engaged extensively with the FDA to address the feedback, including a meeting regarding its rejected application. The FDA has since confirmed that the resubmission adequately addresses the concerns outlined in the prior CRL.
Shares of Replimune have declined 19.6% over the past year against the industry’s 20.2% growth.
Image Source: Zacks Investment Research
The acceptance of the resubmitted BLA relieved investors’ concerns around the RP1/Opdivo combination. Investors now have clarity on the candidate’s path forward, including a clear FDA decision timeline. The surge in the share price reflects improved visibility and confidence, with the asset once again positioned for a potential approval decision in 2026.
More on REPL’s RP1/Opdivo Combination
Replimune’s BLA for the RP1/Opdivo combination in advanced melanoma was accepted for review under the FDA’s Priority Review pathway in January 2025.
BMY’s flagship immuno-oncology drug Opdivo is widely approved across major markets, including the United States and the European Union, to treat a plethora of cancer indications, both as a monotherapy and in combination with Yervoy.
The FDA had previously granted Breakthrough Therapy designation to RP1 in combination with Bristol Myers’ Opdivo for the treatment of adult patients with advanced melanoma who had previously received an anti-PD1-containing regimen.
In October, Replimune reported positive data from another IGNYTE phase II study presented at the ESMO Congress, highlighting promising outcomes in acral melanoma. In this cohort, the RP1/Opdivo combination achieved an objective response rate of 44% with a median duration of response of 11.9 months in patients with acral melanoma. The company is now continuing a larger phase III study evaluating RP1/Opdivo combination versus the physician’s choice of treatment in melanoma patients who progressed on anti-PD1 and anti-CTLA-4 therapies.
Replimune also shared encouraging data demonstrating the safety and efficacy of RP1/Opdivo combination for treating patients with non-melanoma skin cancers.
Additionally, RP1 is being evaluated as a monotherapy in solid organ transplant recipients with skin cancers.
Replimune’s pipelines also have a second oncolytic immunotherapy candidate, RP2, which is currently being evaluated in two separate mid-stage to large-stage studies for the treatment of metastatic uveal melanoma and hepatocellular carcinoma.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have rallied 43.6% over the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88. Shares of CRMD jumped 54.2% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.
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Here's Why Replimune Stock Skyrockets Nearly 131% in 3 Months
Key Takeaways
Shares of Replimune Group (REPL - Free Report) have surged 131.1% over the past three months, fueled by positive regulatory updates.
In October, the FDA accepted the resubmission of the biologics license application (BLA) seeking approval for REPL’s lead pipeline candidate RP1, in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab), for the treatment of advanced melanoma.
The regulatory body has set a target action date of April 10, 2026.
The BLA resubmission follows a complete response letter (CRL) issued in July 2025, in which the FDA cited concerns regarding data heterogeneity in the IGNYTE study population.
The regulatory body also stated that the IGNYTE study is not considered an adequate and well-controlled clinical investigation capable of providing substantial evidence of effectiveness.
The CRL further noted that certain aspects of the confirmatory trial’s study design require clarification, including the contribution of individual components. Additionally, no safety concerns were raised in the letter.
Since then, Replimune has engaged extensively with the FDA to address the feedback, including a meeting regarding its rejected application. The FDA has since confirmed that the resubmission adequately addresses the concerns outlined in the prior CRL.
Shares of Replimune have declined 19.6% over the past year against the industry’s 20.2% growth.
Image Source: Zacks Investment Research
The acceptance of the resubmitted BLA relieved investors’ concerns around the RP1/Opdivo combination. Investors now have clarity on the candidate’s path forward, including a clear FDA decision timeline. The surge in the share price reflects improved visibility and confidence, with the asset once again positioned for a potential approval decision in 2026.
More on REPL’s RP1/Opdivo Combination
Replimune’s BLA for the RP1/Opdivo combination in advanced melanoma was accepted for review under the FDA’s Priority Review pathway in January 2025.
BMY’s flagship immuno-oncology drug Opdivo is widely approved across major markets, including the United States and the European Union, to treat a plethora of cancer indications, both as a monotherapy and in combination with Yervoy.
The FDA had previously granted Breakthrough Therapy designation to RP1 in combination with Bristol Myers’ Opdivo for the treatment of adult patients with advanced melanoma who had previously received an anti-PD1-containing regimen.
In October, Replimune reported positive data from another IGNYTE phase II study presented at the ESMO Congress, highlighting promising outcomes in acral melanoma. In this cohort, the RP1/Opdivo combination achieved an objective response rate of 44% with a median duration of response of 11.9 months in patients with acral melanoma. The company is now continuing a larger phase III study evaluating RP1/Opdivo combination versus the physician’s choice of treatment in melanoma patients who progressed on anti-PD1 and anti-CTLA-4 therapies.
Replimune also shared encouraging data demonstrating the safety and efficacy of RP1/Opdivo combination for treating patients with non-melanoma skin cancers.
Additionally, RP1 is being evaluated as a monotherapy in solid organ transplant recipients with skin cancers.
Replimune’s pipelines also have a second oncolytic immunotherapy candidate, RP2, which is currently being evaluated in two separate mid-stage to large-stage studies for the treatment of metastatic uveal melanoma and hepatocellular carcinoma.
Replimune Group, Inc. Price
Replimune Group, Inc. price | Replimune Group, Inc. Quote
REPL’s Zacks Rank & Stocks to Consider
Replimune currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) and CorMedix (CRMD - Free Report) . Both currently sport 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, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have rallied 43.6% over the past year.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.
Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88. Shares of CRMD jumped 54.2% over the past year.
CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.