RP1, BLA and Nivolumab

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.
The FDA Accepts a BLA for RP1 Plus Opdivo in Advanced Melanoma
The FDA has accepted a BLA for treatment with RP1 in combination with Opdivo for patients with advanced melanoma who have progressed on prior therapy.
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.
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 melanoma candidate for priority review
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma.
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.
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's SWOT analysis: oncolytic immunotherapy stock faces pivotal year
Replimune Group Inc (NASDAQ:REPL), a biotechnology company specializing in oncolytic immunotherapy for cancer treatment, ...
Strong Buy Rating for Replimune Group Due to Promising RP1 + Opdivo Results and Favorable FDA Review
In a report released today, Robert Burns from H.C. Wainwright reiterated a Buy rating on Replimune Group (REPL – Research Report), with a price ...
Replimune price target raised to $21 from $17 at H.C. Wainwright
H.C. Wainwright analyst Robert Burns raised the firm’s price target on Replimune (REPL) to $21 from $17 and keeps a Buy rating on the shares. The firm expects a “relatively uneventful” FDA review ...
Barclays maintains Replimune stock with $17 target
Barclays (LON:BARC) reaffirmed its positive stance on Replimune Group (NASDAQ:REPL), maintaining an Overweight rating and a $17.00 price target, representing significant upside from the current price ...
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Chinese National Yu Hao, Who Caused State Losses of Rp1.020 Trillion Due to Illegal Gold Mining, is Acquitted
Indonesia's Pontianak High Court in the spotlight after acquitting a Chinese foreign national, Yu Hao, 49 years old, in an ...