Join our FREE personalized newsletter for news, trends, and insights that matter to everyone in America

Newsletter
New

Repl Stock Up 80% In A Month On Tudriqev Launch & Pipeline Progress

Card image cap

Shares of Replimune Group REPL 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 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.

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 and Adaptive Biotechnologies ADPT, 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%.

Zacks' Research Chief Names "Stock Most Likely to Double"

Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.

Of course, all our elite picks aren't winners, but this one could far surpass earlier Zacks' Stocks Set to Double like D-Wave Quantum, which shot up +680.1%.

Free: See Our Top Stock And 4 Runners Up

This article originally published on Zacks Investment Research (zacks.com).

Zacks Investment Research