Replimune Faces Mounting Legal Challenges Following Drug Rejection

Biopharmaceutical company Replimune finds itself confronting significant legal challenges as multiple shareholder class action lawsuits emerge in the wake of a regulatory setback for its lead cancer therapy. The litigation centers on allegations that company leadership provided materially misleading statements regarding the prospects of its pivotal IGNYTE clinical trial.

The catalyst for this legal pressure emerged on July 22, 2025, when the U.S. Food and Drug Administration declined to approve RP1, Replimune’s investigational therapy, in combination with nivolumab for advanced melanoma. The regulatory agency determined that the submitted data from the IGNYTE trial failed to provide substantial evidence of effectiveness, describing the study as “inadequate and not sufficiently controlled.”

This regulatory decision triggered an immediate and severe market reaction. Read more...