RP1, Nivolumab and Replimune

BLA Accepted for Melanoma Combination Therapy, RP1 and Nivolumab
The investigational advanced melanoma combination therapy consisting of RP1 and nivolumab have a PDUFA action date of July 22, 2025.
Replimune's BLA For RP1-Nivolumab Combo Gets FDA Approval For Advanced Melanoma, Stock Surges
(RTTNews) - Replimune Group, Inc. (REPL), Tuesday announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for RP1 in combination with Nivolumab for the treatment of advanced melanoma. Following the announcement, Replimune's stock is currently climbing 26.09 percent, to $12.78 on the Nasdaq.
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1,
Replimune Stock Soars 16% on FDA Priority Review for Advanced Melanoma Therapy
Replimune Group ( REPL, Financials) shares surged 17% to $11.85 as of 10:18 a.m. ET Tuesday after the U.S. Food and Drug Administration granted Priority Review for its Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma.
FDA Accepts BLA for RP1 With Nivolumab in Advanced Melanoma
The biologics license application for RP1 (vusolimogene oderparepvec) plus nivolumab in advanced melanoma was accepted by the FDA with priority review.
REPL Stock Rises on FDA's Priority Review for Melanoma Drug BLA
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.
FDA accepts Replimune's advanced melanoma therapy BLA
Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has been accepted by the U.
Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for ...
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FDA accepts Replimune’s melanoma candidate for priority review
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene ...
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Replimune announces RP2 development program advances
Replimune (REPL) Group announced that the first ... “On the heels of our BLA submission for RP1 and designation as breakthrough therapy, we are pleased that the first patients have been enrolled ...
Charles Schwab Posts Upbeat Earnings, Joins Redwire, Evolus, Replimune Group And Other Big Stocks Moving Higher On Tuesday
Evolus Inc EOLS shares jumped 35.6% to $14.25 after the company announced it expects FDA approval for Evolysse gels within 90 ...
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Replimune Group, Inc.
Replimune Group, Inc. is a clinical-stage biotechnology company. It engages in the business of developing oncolytic immunotherapies for the treatment of cancer. The company was founded by Philip ...
Replimune stock price target raised to $27 by BMO Capital
Replimune Group Inc . (NASDAQ:REPL), currently trading at $11.70, saw its price target increased to $27.00 from $18.00 by BMO Capital, with the firm maintaining an Outperform rating on the stock.