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.
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 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 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.
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 BLA acceptance, priority review for RP1
Group announced that the U.S. Food and Drug Administration, FDA, has accepted the Biologics License Application, BLA, for RP1
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Beckermann and Participants Discuss Second-Line ccRCC Options
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Nivolumab Plus Ipilimumab Bests Chemo in MSI-H, dMMR Colorectal Cancer
In the primary efficacy population, the median progression-free survival was not reached in the nivolumab-ipilimumab arm and was 5.9 months in the chemotherapy arm. The combination of nivolumab ...
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Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer
Melanoma Among Adult Survivors of Childhood Cancer: A Report From the Childhood Cancer Survivor Study Adults with stage IB-IIIA (American Joint Committee on Cancer seventh edition) resectable NSCLC ...
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The Targeted Pulse: Check Out Positive and Negative Updates in Head and Neck Cancer, and How the FDA is Handling Advancements in Lung Cancer Treatment
HNSCC, whereas the combination of durvalumab and cetuximab showed limited success. Abenacianine received fast track designation for lung cancer surgery, the combination of amivantamab and Lazertinib ...