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.
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 anti-CTLA-4 treatment. For more information, please visit https://replimune.com/clinical-trials/ignyte-3/.
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 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 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
Targeted Oncology2h
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 ...
The Pharma Letter11h
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 ...
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 ...
The American Journal of Managed Care21d
FDA Approves First Subcutaneous Nivolumab Injection in Most Solid Tumors
Subcutaneous nivolumab and hyaluronidase-nvhy is FDA-approved for adult solid tumors, offering a new administration route for PD-1 inhibitors. The phase 3 CheckMate-67T trial confirmed ...
oncnursingnews6dOpinion
Opinion: Subcutaneous Nivolumab Offers an Effective Alternative to Intravenous Administration
Oncology nurses can educate patients on the benefits of subcutaneous administration, including reduced time in the infusion ...
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 ...