Replimune bounces back on FDA panel vote

Replimune’s RP1 vusolimogene oderparepvec, patients who are hoping to benefit from it, and investors who have backed the company, have experienced the full biotech roller-coaster ride.

When Replimune Group Inc. (NASDAQ:REPL) submitted a BLA for RP1 plus nivolumab in anti–PD-1–refractory advanced melanoma in November 2024, it seemed to have the wind at its back — a breakthrough therapy designation, priority review, and the strength of the single-arm IGNYTE Phase I/II registrational cohort. ...