Jefferies Sees Reduced Visibility for Replimune Group, Inc. (REPL) Following FDA Decision

We recently compiled a list of the 10 Best Biotech Stocks Under $10 to Buy. Replimune Group, Inc. is among the best biotech stocks to invest in.

TheFly reported on April 13 that Jefferies cut its rating on REPL from Buy to Hold and reduced its price target sharply to $2 from $13. The firm cited increased uncertainty following the FDA’s complete response letter regarding RP1. According to management, further development of RP1 will not proceed unless an accelerated approval pathway is secured within the expected timeframe. Jefferies indicated that the setback creates a more difficult outlook for the program and limits near-term visibility. The firm also noted that the company’s overall development trajectory now appears less clear, with future progress dependent on regulatory outcomes and resolution of current approval concerns.

On April 10, Replimune Group, Inc. (NASDAQ:REPL) stated that the FDA’s complete response letter reflects positions that differ from those communicated in earlier regulatory interactions, particularly the September 2025 Type A meeting. The company noted that a new review team handled the resubmission and did not engage directly despite offers for discussion.

It highlighted that prior agency feedback had supported aspects of the RP1 plus nivolumab dataset, including acknowledgment of challenges in running a randomized control arm and acceptance of certain evidence frameworks. REPL also pointed to earlier regulatory discussions suggesting a single-arm dataset could be sufficient under accelerated approval conditions, contrasting with the later review outcome and concerns raised in the CRL.

Replimune Group, Inc. (NASDAQ:REPL) is a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for cancer. Its proprietary RPx platform is designed to stimulate the immune system to recognize and destroy tumor cells, either alone or in combination with other treatments.

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