Replimune Stock Slides Over 12% Ahead of Key FDA Panel for Melanoma Drug

Replimune (REPL) shares plunged in morning trading as investors de-risked their positions ahead of an anticipated U.S. Food and Drug Administration (FDA) advisory committee meeting for the company's lead cancer candidate, RP1.

High-Stakes Regulatory Review

The stock slid 12.4% to $8.50 as the market priced in the risk associated with the upcoming regulatory catalyst, according to a report from Investing.com. The FDA had previously notified Replimune to expect the advisory committee review in late July, placing this week squarely in the high-risk window for investors.

The panel will review RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. This meeting precedes the FDA's target decision date for the drug's application, which is set for August 2, 2026.

Context of Previous Rejections

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Investor caution is compounded by the drug's difficult regulatory history. This is Replimune's third attempt to gain FDA approval for RP1 in this indication after receiving two prior complete response letters from the agency. The outcome of the advisory committee's review is seen as a critical test for the resubmitted application.

Replimune's stock had recovered significantly from a 52-week low of $1.50, but Monday's sell-off demonstrates the market's sensitivity to this binary regulatory event. The decline was company-specific, occurring while major U.S. indices like the S&P 500 and Nasdaq were trading higher.

Financial Position Adds Urgency

The company's financial runway adds to the pressure for a positive outcome. As of late March 2026, Replimune reported a cash position of approximately $268.9 million, which it expects will fund operations only into early 2027. A successful approval is therefore crucial for the company's financial stability and its ability to commercialize its lead candidate.