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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
News
Return to FDA Calendar
RELATED NEWS (Replimune Group Inc.)
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Replimune's Oncolytic Viral Therapy For Melanoma Faces Second Shot At FDA Approval
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