Replimune (REPL) is planning in the coming days to resubmit a new application with the US Food and Drug Administration for its experimental advanced melanoma treatment, The Wall Street Journal reported Friday, citing unnamed people familiar with the matter.

According to the report, it is unclear whether Replimune will submit new clinical data or additional analyses of existing trial results in support of the application.

The FDA rejected Replimune's application in July 2025 and again in April, stating that data from a single-arm trial without a comparison group did not demonstrate that the treatment worked, the report said. The agency also noted that the mix of patients enrolled in the study made the results difficult to interpret.

Replimune did not immediately respond to requests for comment from MT Newswires.

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