Replimune (REPL) Stock Jumps: FDA Resubmission for RP1 Melanoma

Font: Financial Modeling Prep  • Jun 03, 2026

Replimune Group (NASDAQ: REPL) Stock Surges on FDA Resubmission for Melanoma Drug RP1

• Replimune Group (NASDAQ: REPL)'s oncolytic immunotherapy, RP1, for advanced melanoma, received a significant boost with FDA agreement for Biologics License Application (BLA) resubmission.
• The company's stock price surged by 85.7% following the FDA announcement, indicating strong investor confidence despite current unprofitability.
• Analysts forecast a Q2 2026 earnings per share (EPS) of -$0.73 and revenues of $5.57 million, reflecting its research and development-heavy development stage.

Replimune Group (NASDAQ: REPL) is a leading biotechnology company that develops oncolytic immunotherapies, which are innovative treatments using modified viruses to fight cancer. Its primary drug candidate, RP1, is specifically being developed to treat advanced melanoma. This promising treatment is used in combination with Opdivo, a drug from established pharmaceutical company Bristol Myers Squibb (NYSE: BMY).

Replimune Group is scheduled to release its quarterly earnings report on June 4, 2026. For the upcoming quarter, Wall Street analysts are forecasting a loss, with an earnings per share (EPS) of -$0.73. The company's estimated revenues for the period are approximately $5.57 million, reflecting its current development stage and significant investment in research and development.

The negative EPS forecast is consistent with Replimune Group's recent financial results. The company currently has a negative Price-to-Earnings (P/E) ratio of -2.92, indicating it has not been profitable over the last twelve months. A negative P/E ratio is common for biotechnology companies that are still investing heavily in research and development and have not yet brought a product to market.

Recently, Replimune Group's stock price increased by 85.7% after a major regulatory announcement. The company reached an agreement with the U.S. Food and Drug Administration (FDA) to resubmit its Biologics License Application (BLA) for RP1. This application is a formal request to allow a pharmaceutical product to be introduced into the market, marking a critical step towards drug approval.

The FDA will prioritize its review of the melanoma drug, recognizing the significant need for new melanoma treatments. This development gives the drug candidate a third chance at regulatory approval after White House officials intervened, as highlighted by the Wall Street Journal. The BLA resubmission is based on positive results from the pivotal IGNYTE clinical study, reinforcing the potential efficacy of RP1.