Replimune Group Plunges 38.29% After FDA Rejects RP1

On August 4, 2025, Replimune Group's stock experienced a significant drop of 38.29% in pre-market trading, marking a substantial decline in its share price.

Replimune Group, Inc. (REPL) faced a major setback on Tuesday when the U.S. Food and Drug Administration (FDA) rejected the company's Biologics License Application (BLA) for its drug RP1. This rejection has raised concerns among investors about the future prospects of the company's pipeline and its ability to bring new treatments to market.

The rejection of the BLA for RP1 is a significant blow to Replimune Group, as the drug was seen as a potential breakthrough in the treatment of certain types of cancer. The company had been investing heavily in the development of RP1, and its rejection by the FDA has led to a loss of confidence among investors.

Despite the setback, Replimune Group has stated that it remains committed to developing innovative treatments for cancer and other diseases. The company plans to work closely with the FDA to address the issues raised in the rejection and to submit a new application for RP1 in the future. However, the timeline for this process remains uncertain, and investors will be closely watching the company's progress in the coming months.