RP1, 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.
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.
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 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.
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.
Targeted Oncology1d
5-Year Update Sustains Nivolumab/Chemo Efficacy in Frontline Gastric/GEJ/Esophageal Cancer
CheckMate 649 trial showed sustained efficacy with frontline nivolumab plus chemotherapy vs chemotherapy alone in patients with gastric cancers.
Cure Today4d
The Significance of the Subcutaneous Opdivo FDA Approval in Solid Tumors
Dr. Balazs Halmos discusses the significance of the approval of subcutaneous Opdivo and what this treatment formulation means ...
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 ...
Targeted Oncology1d
Nivolumab Plus Chemo Improves OS in Chinese Patients With Advanced Gastric/GEJ Cancer
The phase 3 CheckMate 649 trial showed that nivolumab plus chemotherapy significantly improved long-term overall survival in Chinese patients with advanced gastric, gastroesophageal junction, and ...
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used ...
Daily12d
CDSCO Panel approves Dr Reddys proposal to increase patients from 241 to 265 in India for anticancer drug Nivolumab study
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has ...