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FDA Approves Replimune Melanoma Therapy as Fraud Probe Looms

8/8/2026

42 9 Full Breakdown

Summary

FDA Grants Approval

The FDA granted accelerated approval to Replimune's TUDRIQEV with nivolumab for advanced melanoma on August 6, 2026.
An advisory committee voted 10-3 in favor of the therapy on July 30, 2026.
The IGNYTE trial reported a 24.2% response rate in 91 patients and a list price of $450,000 per course.
Pomerantz LLP and Glancy Prongay & Rotter LLP are probing securities-fraud claims and demand IGNYTE-3 Phase 3 data from ~400 patients due late 2027.

Summary

Replimune Challenges FDA

White House intervened after Replimune accused the FDA of shifting guidance.
Replimune claims an earlier FDA review deemed its evidence adequate before the April rejection, prompting a complaint of inconsistency.
Replimune warned it could abandon Tudriqev if the regulator reversed its decision after Phase 3 results.
Trial investigators and physicians publicly defended Tudriqev as a potential lifeline for patients lacking options.

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FDA Grants Approval

The FDA granted accelerated approval to Replimune's TUDRIQEV with nivolumab for advanced melanoma on August 6, 2026.
An advisory committee voted 10-3 in favor of the therapy on July 30, 2026.
The IGNYTE trial reported a 24.2% response rate in 91 patients and a list price of $450,000 per course.
Pomerantz LLP and Glancy Prongay & Rotter LLP are probing securities-fraud claims and demand IGNYTE-3 Phase 3 data from ~400 patients due late 2027.

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