TUDRIQEV (vusolimogene oderparepvec-wtpg) plus nivolumab was approved by the FDA on August 6, 2026 for advanced melanoma previously treated with an anti-PD-1 regimen.
Verified against: FDA action day August 6, 2026 (CBER accelerated approval notice) · Announcement August 6, 2026 (sponsor announcement) · Goal date August 2, 2026 (Replimune 8-K).
TUDRIQEV (vusolimogene oderparepvec-wtpg) granted accelerated approval, in combination with nivolumab, for adults with unresectable advanced cutaneous melanoma who progressed on a PD-1 blocking antibody-based regimen (Aug 6 2026).
This was the third review cycle. The FDA issued a Complete Response Letter on July 21, 2025, a second action letter on April 10, 2026, and accepted the Class 1 resubmission on June 26, 2026 with a goal date of August 2, 2026. The agency acted on August 6, four days past the goal date. Approval is accelerated, based on objective response rate and duration of response in the single-arm IGNYTE study (ORR 24%, median duration of response 14.1 months), and continued approval may be contingent on verifying benefit in the confirmatory Phase 3 IGNYTE-3 trial, whose primary endpoint is overall survival and which is due to complete in 2030. An advisory committee voted 10 to 3 on July 30, 2026 that the IGNYTE results were evaluable and clinically meaningful. The label carries no boxed warning and no REMS.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA press announcement, August 6, 2026
FDA record of the action: the FDA approved on August 6, 2026, per CBER accelerated approval notice (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 11,045,336 | $122.3 million | filed August 14, 2026 |
| RTW Investments | 7,411,581 | $82.0 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Yes. The FDA approved the application for TUDRIQEV (vusolimogene oderparepvec-wtpg) on August 6, 2026, per the FDA's own record. The primary source is linked on this page.
TUDRIQEV (vusolimogene oderparepvec-wtpg) is a Replimune Group, Inc. (REPL) program. The FDA decision came on August 6, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), REPL moved -30.2%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.