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Replimune Group, Inc. REPL announced that the FDA has accepted the biologics license application (BLA) for its lead pipeline candidate, RP1 (vusolimogene oderparepvec), in combination with Bristol Myers’ BMY Opdivo (nivolumab) to treat adult patients with advanced melanoma.
With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on July 22, 2025.
Shares of REPL were up 16.9% on Jan. 21 following the announcement of the news.
The FDA also informed REPL that the agency is not currently planning to hold an advisory committee meeting related to the BLA, as it has not identified any potential review issues at this point.
In the past year, shares of Replimune have rallied 50.7% against the industry’s decline of 14.8%.
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More on REPL's BLA for the RP1/Opdivo Combo
Replimune submitted the BLA for the RP1/Opdivo combo in advanced melanoma in November 2024.
The said BLA was based on the primary analysis data of the IGNYTE study, which evaluated RP1 in combination with Opdivo for treating patients with anti-PD-1 failed melanoma.
Meanwhile, the confirmatory phase III IGNYTE-3 study is currently underway, with more than 100 sites planned worldwide.
The IGNYTE-3 study is investigating the combo of RP1 plus Opdivo for treating advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy or who are not eligible for anti-CTLA-4 treatment.
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 BMY’s Opdivo for treating adult patients with advanced melanoma who have previously received an anti-PD1-containing regimen.
Apart from the melanoma indication, the company 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 currently does not have any approved products in its portfolio. Hence, the successful development of RP1 and other pipeline candidates remains a key focus for the company.
REPL's Zacks Rank & Stocks to Consider
Replimune currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Voyager Therapeutics, Inc. VYGR and Castle Biosciences, Inc. CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.