The FDA again rejected Replimune’s oncolytic virus therapy for advanced melanoma after the company failed to resolve trial-related doubts, according to the agency’s renewed decision. Replimune previously received a refusal in July and returned for a reconsideration, with regulators maintaining concerns about the evidence supporting the program. The setback adds to a broader reassessment inside the FDA over the amount and type of clinical data needed to clear next-generation biologics programs. Replimune’s engineered virus is designed to activate antitumor immunity, but the agency’s repeated rejection signals that the path to approval remains contingent on strengthening the clinical package. For investors and competitors, the action underscores how FDA expectations for oncolytic viral and immuno-oncology platforms may be tightening, particularly where endpoint interpretation and trial design questions persist.