Replimune Group (REPL), a clinical-stage biotechnology company, announced on Thursday that it has submitted a biologics license application to the FDA for RP1, its lead product candidate, in combination with Bristol-Myers Squibb's Opdivo, for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.
The submission was made under the Accelerated Approval pathway.
A confirmatory phase III study of RP1 in combination with Opdivo in advanced melanoma patients who have progressed on anti-PD1 and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment, dubbed IGNYTE-3, is currently enrolling patients.
The company has also announced it has received Breakthrough Therapy designation from the FDA for RP1 in combination with Opdivo for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1-containing regimen.
REPL closed Thursday's trading at $11.05, down 1.60%
For comments and feedback contact: editorial@rttnews.com
Business News
April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.