Replimune Group, Inc. 8K

Replimune furnished an investor/Reg FD presentation used for a July 30, 2026 FDA advisory committee meeting to support accelerated approval of its RP1 (TUDRIQEV) plus nivolumab regimen for anti‑PD‑1‑refractory advanced cutaneous melanoma based on IGNYTE Phase 2 data and an ongoing IGNYTE‑3 confirmatory trial.

The Form 8‑K includes Replimune, Inc.’s Exhibit 99.1 slide deck prepared for the July 30, 2026 meeting of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee, in which the company presents clinical, safety, and mechanistic data for its oncolytic viral therapy vusolimogene oderparepvec‑wtpg (RP1, proposed trade name TUDRIQEV) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who have progressed on prior anti‑PD‑1 therapy; the materials emphasize an objective response rate of 33.6% and durable responses from the single‑arm IGNYTE Phase 2 study, argue for contribution of effect beyond nivolumab alone, position the benefit‑risk profile as favorable relative to existing options such as lifileucel, and support Replimune’s request for accelerated approval while noting that the randomized confirmatory IGNYTE‑3 overall survival trial is ongoing with data expected in 2030.

Filing Facts

CIK

1737953

Ticker

REPL

Form

8K

Source Type

fda

Accession

0001104659-26-088481

Alert Tier

8