Why Did Replimune Group Stock Soar 9.84% Ahead of FDA Decision?

On July 21, 2025, Replimune Group's stock surged by 9.84% in pre-market trading, reflecting a significant upward momentum in investor sentiment.

Replimune Group is set to receive a pivotal FDA decision on July 22, 2025, regarding its drug RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. This upcoming decision is a critical milestone for the company, as it could potentially validate the efficacy and safety of its therapeutic approach, thereby driving further investor interest and stock price appreciation.

Additionally, the broader biotech sector is experiencing heightened activity, with several other companies awaiting FDA decisions in July. This collective anticipation within the industry may be contributing to the positive sentiment surrounding Replimune Group, as investors speculate on potential regulatory successes that could benefit the entire sector.