# FDA Briefing Documents Slam Replimune Melanoma Data Package Ahead of AdCom

> fda · REPORTED · 2026-07-28

On July 28, 2026, FDA briefing documents ahead of a July 30 advisory committee meeting stated that Replimune's statistical analysis method for its oncolytic virus RP-1 (vusolimogene oderparepvec) in melanoma inflated responses in the phase II Ignyte trial, calling the data package not interpretable; shares fell approximately 38%. The AdCom outcome will be pivotal for a potential BLA submission.

About Replimune: Replimune is a clinical-stage biotech developing oncolytic immunotherapies, including RP-1, an engineered herpes simplex virus designed to selectively infect and destroy tumor cells while activating systemic anti-tumor immunity.

- Company: Replimune
- Sector: oncology
- Primary source: https://www.bioworld.com/articles/732939-replimunes-rollercoaster-fda-adcom-signals-another-bumpy-ride

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.