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.
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.
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.
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.
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
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,
Australian research makes breakthrough in boosting breast cancer cure rate
Australian researchers have made a breakthrough in improving the cure rate for the most common form of breast cancer. An ...
Medscape24m
How New Research Is Redefining Melanoma Treatment
Research has introduced daromun, therapeutic vaccines, and novel combinations for metastatic melanoma, reshaping the ...
Healio11d
Adjuvant nivolumab improves DFS in high-risk head and neck cancer
The addition of adjuvant nivolumab to standard-of-care radiotherapy and cisplatin improved survival for patients with locally ...
Oncology Nurse Advisor9d
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 ...
Targeted Oncology7h
Beckermann and Participants Discuss Second-Line ccRCC Options
During a Case-Based Roundtable® event, Kathryn E. Beckermann, MD, PhD, discussed second-line regimens with event participants ...