We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
REPL Stock Up 80% in a Month on Tudriqev Launch & Pipeline Progress
Read MoreHide Full Article
Key Takeaways
Replimune shares surged 80% in a month, driven by Tudriqev's commercial launch and pipeline progress.
Tudriqev's early adoption at leading melanoma centers and broad label support its commercial potential.
Tudriqev's strong early adoption and broad treatment label boost its market potential.
Shares of Replimune Group (REPL - Free Report) have surged 80% over the past month compared with the industry’s 10.9% growth, primarily driven by the commercial launch of its newly approved cancer therapy, Tudriqev (formerly RP1) and growing investor confidence in its revenue-generation potential. Better-than-expected earnings results in the fiscal second quarter of 2027 and continued pipeline progress also contributed to the stock’s recent rally.
In August 2026, the FDA granted accelerated approval to Replimune's lead product, Tudriqev, in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) for the treatment of adults with unresectable advanced cutaneous melanoma whose disease has progressed following an anti-PD-1 antibody-based regimen.
BMY’s blockbuster immuno-oncology drug Opdivo is approved across multiple tumor types, including lung, melanoma and kidney cancers. Notably, Tudriqev became commercially available in the United States in early October, marking an important transition for Replimune from a clinical-stage company to a commercial-stage business.
The initial launch has shown encouraging progress, with the first patients receiving Tudriqev in October. Several leading melanoma centers have already added the drug to their formularies and started treating patients. These developments indicate early physician interest and provide encouraging signs of market adoption, raising expectations for the drug's commercial prospects.
Tudriqev's broad label could further support its market potential. The therapy can be administered with Opdivo following progression on anti-PD-1 treatment without requiring patients to undergo prior BRAF-targeted therapy. It can also be injected into superficial, deep and visceral tumors, including lung and liver lesions, with retreatment permitted when clinically appropriate.
Meanwhile, Replimune's global phase III IGNYTE-3 confirmatory study remains on track and is actively enrolling patients. The trial is evaluating Tudriqev in combination with Opdivo against physician's choice in patients with advanced melanoma who have progressed after anti-PD-1 and anti-CTLA-4 therapies or cannot receive anti-CTLA-4 treatment.
However, investors should closely monitor the commercial uptake of Tudriqev and the progress of its confirmatory trial, as the sustainability of the rally will depend on the company's ability to convert early commercial interest into meaningful revenues.
Beyond Tudriqev, Replimune is advancing RP2, another investigational oncolytic immunotherapy developed using its proprietary RPx platform. The candidate is being evaluated across multiple cancer indications.
Replimune is evaluating RP2 in the registration-directed phase II/III REVEAL study for patients with metastatic uveal melanoma, a rare form of eye cancer. The study compares RP2 in combination with Opdivo against Yervoy (ipilimumab) in combination with Opdivo. Overall survival and progression-free survival are the primary endpoints. Patient enrollment in the study is ongoing. Positive results could provide Replimune with another opportunity to expand its presence in oncology beyond cutaneous melanoma. The candidate is also being evaluated in combination with Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) as a second-line treatment in patients with locally advanced, unresectable or metastatic hepatocellular carcinoma.
The company has added a cohort to investigate RP2 in combination with durvalumab for biliary tract cancer. Preliminary findings from both studies are expected in the first quarter of 2027.
The company incurred a loss of 54 cents per share in the fiscal second quarter of 2027 compared with a loss of 90 cents in the year-ago quarter. The metric also topped the Zacks Consensus Estimate of loss of 70 cents per share. The company expects its existing cash resources to fund operations for more than 12 months, providing some financial flexibility as it continues to commercialize Tudriqev and advance the clinical pipeline.
Some other top-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , carrying a Zacks Rank #2 each.
Over the past 30 days, loss per share estimates for AC Immune have narrowed from 60 cents to 54 cents for 2026. Over the same period, estimates for 2027 earnings per share have increased from 17 cents to 43 cents. ACIU’s shares have plunged 28% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 37.79%.
Over the past 30 days, loss per share estimates for Adaptive Biotechnologies have narrowed from 55 cents to 44 cents for 2026. Over the same period, estimates for 2027 loss per share have also improved from 17 cents to 8 cents. ADPT’s shares have surged 84.3% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 53.62%.
View the Zacks #1 Rank List
Image: Bigstock
REPL Stock Up 80% in a Month on Tudriqev Launch & Pipeline Progress
Key Takeaways
Shares of Replimune Group (REPL - Free Report) have surged 80% over the past month compared with the industry’s 10.9% growth, primarily driven by the commercial launch of its newly approved cancer therapy, Tudriqev (formerly RP1) and growing investor confidence in its revenue-generation potential. Better-than-expected earnings results in the fiscal second quarter of 2027 and continued pipeline progress also contributed to the stock’s recent rally.
Image Source: Zacks Investment Research
Tudriqev’s Commercial Launch Boosts REPL’s Growth Prospects
In August 2026, the FDA granted accelerated approval to Replimune's lead product, Tudriqev, in combination with Bristol Myers’ (BMY - Free Report) Opdivo (nivolumab) for the treatment of adults with unresectable advanced cutaneous melanoma whose disease has progressed following an anti-PD-1 antibody-based regimen.
BMY’s blockbuster immuno-oncology drug Opdivo is approved across multiple tumor types, including lung, melanoma and kidney cancers. Notably, Tudriqev became commercially available in the United States in early October, marking an important transition for Replimune from a clinical-stage company to a commercial-stage business.
The initial launch has shown encouraging progress, with the first patients receiving Tudriqev in October. Several leading melanoma centers have already added the drug to their formularies and started treating patients. These developments indicate early physician interest and provide encouraging signs of market adoption, raising expectations for the drug's commercial prospects.
Tudriqev's broad label could further support its market potential. The therapy can be administered with Opdivo following progression on anti-PD-1 treatment without requiring patients to undergo prior BRAF-targeted therapy. It can also be injected into superficial, deep and visceral tumors, including lung and liver lesions, with retreatment permitted when clinically appropriate.
Meanwhile, Replimune's global phase III IGNYTE-3 confirmatory study remains on track and is actively enrolling patients. The trial is evaluating Tudriqev in combination with Opdivo against physician's choice in patients with advanced melanoma who have progressed after anti-PD-1 and anti-CTLA-4 therapies or cannot receive anti-CTLA-4 treatment.
However, investors should closely monitor the commercial uptake of Tudriqev and the progress of its confirmatory trial, as the sustainability of the rally will depend on the company's ability to convert early commercial interest into meaningful revenues.
RP2 Pipeline Offers REPL’s Additional Growth Opportunities
Beyond Tudriqev, Replimune is advancing RP2, another investigational oncolytic immunotherapy developed using its proprietary RPx platform. The candidate is being evaluated across multiple cancer indications.
Replimune is evaluating RP2 in the registration-directed phase II/III REVEAL study for patients with metastatic uveal melanoma, a rare form of eye cancer. The study compares RP2 in combination with Opdivo against Yervoy (ipilimumab) in combination with Opdivo. Overall survival and progression-free survival are the primary endpoints. Patient enrollment in the study is ongoing. Positive results could provide Replimune with another opportunity to expand its presence in oncology beyond cutaneous melanoma. The candidate is also being evaluated in combination with Roche's Tecentriq (atezolizumab) and Avastin (bevacizumab) as a second-line treatment in patients with locally advanced, unresectable or metastatic hepatocellular carcinoma.
The company has added a cohort to investigate RP2 in combination with durvalumab for biliary tract cancer. Preliminary findings from both studies are expected in the first quarter of 2027.
Replimune Group, Inc. Price and Consensus
Replimune Group, Inc. price-consensus-chart | Replimune Group, Inc. Quote
REPL’s Better-Than-Expected Earnings Results
The company incurred a loss of 54 cents per share in the fiscal second quarter of 2027 compared with a loss of 90 cents in the year-ago quarter. The metric also topped the Zacks Consensus Estimate of loss of 70 cents per share. The company expects its existing cash resources to fund operations for more than 12 months, providing some financial flexibility as it continues to commercialize Tudriqev and advance the clinical pipeline.
REPL’s Zacks Rank & Other Stocks to Consider
Replimune currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some other top-ranked stocks in the biotech sector are AC Immune (ACIU - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , carrying a Zacks Rank #2 each.
Over the past 30 days, loss per share estimates for AC Immune have narrowed from 60 cents to 54 cents for 2026. Over the same period, estimates for 2027 earnings per share have increased from 17 cents to 43 cents. ACIU’s shares have plunged 28% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 37.79%.
Over the past 30 days, loss per share estimates for Adaptive Biotechnologies have narrowed from 55 cents to 44 cents for 2026. Over the same period, estimates for 2027 loss per share have also improved from 17 cents to 8 cents. ADPT’s shares have surged 84.3% year to date.
Adaptive Biotechnologies’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 53.62%.