REPL Stock On Track For Worst Drop In Nearly 7 Months Ahead Of FDA Decision On Skin Cancer Drug

• The FDA issued a complete response letter regarding the application for RP1 in combination with Nivolumab for the treatment of advanced melanoma in late July.
• Following months of engagement between the company and the FDA, Replimune subsequently resubmitted its application in October with additional information, data and analyses.
• RP1 is Replimune’s lead product candidate.

Shares of Replimune Group Inc (REPL) fell 15% on Wednesday as the deadline for the U.S. Food and Drug Administration’s decision on its skin cancer therapy RP1 draws close.

If losses hold, REPL is on track for its worst session in nearly seven months.

The FDA is slated to decide on the company’s application for RP1 in the treatment of advanced melanoma by April 10. RP1 is Replimune’s lead product candidate.

RP1’s Past Issues

In late July 2025, the FDA issued a complete response letter regarding the application for RP1 in combination with Nivolumab for the treatment of advanced melanoma.

The agency said in the letter that it is unable to approve the application in its present form, and indicated that the trial conducted by the company for the drug is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.

Following months of engagement between the company and the FDA, Replimune subsequently resubmitted its application in October with additional information, data, and analyses.

How Did Retail Traders React?

On Stocktwits, retail sentiment around REPL stock fell from ‘bullish’ to ‘neutral’ territory over the past 24 hours, while message volume remained at extremely high levels. Retail chatter around the stock has increased 171% over the past seven days, Stocktwits data showed.

A retail user said that the FDA might ask for a fresh trial for approval, pitching the chances for a green light from the agency at below 20%.

Yet another user dismissed concerns about trial design.

Another user opined that the stock can either triple or wipe out a majority of its value after the FDA decision.

REPL stock has fallen 7% over the past 12 months.

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