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FDA Calendar - Replimune Group Inc.

Company Name Replimune Group Inc.
REPL
Drug Name RP1 (Resubmitted BLA)
Event Name FDA decision on RP1 in combination with Bristol Myers Squibb's Opdivo for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen
Event Date 04/10/2026
Outcome Date 04/10/2026
Outcome FDA issued a Complete Response Letter for RP1 again on Apr.10, 2026
Drug Status FDA issued a Complete Response Letter for RP1 on July 22, 2025
Rival Drugs
Market Potential
Other Approvals
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