FDA Issues Complete Response Letter to Replimune for RP1 Biologics License Application Targeting Advanced Melanoma

Replimune has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for RP1, an investigational therapy aimed at treating advanced melanoma. The CRL indicates that the FDA has completed its review of the application but cannot approve it in its current form.

According to the company, the FDA outlined specific issues in the CRL that need to be addressed before approval can be granted. These include additional information or clarification related to certain aspects of RP1’s clinical data and manufacturing processes. Replimune stated it is reviewing the feedback provided by the agency and intends to work closely with regulators to resolve these matters. The company did not disclose a timeline for resubmitting its application or provide further details on next steps following receipt of the letter.

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Date: April 10, 2026

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GOAI