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%
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