Replimune reports early TUDRIQEV launch progress, $307.8 million cash as of Sept. 30, 2026
The company said more than 15 institutions have prescribed its melanoma therapy since first patient delivery on October 6, while its confirmatory Phase 3 trial continues enrolling.
Replimune Group, Inc. announced on October 28, 2026 that TUDRIQEV (vusolimogene oderparepvec-wtpg), previously referred to as RP1, is now commercially available in the United States for use in combination with nivolumab for the treatment of adults with advanced melanoma.1 The company said TUDRIQEV was first delivered to patients for advanced melanoma on October 6th, and more than 15 institutions have prescribed TUDRIQEV.1
On the launch, Replimune said it has actively engaged with more than 70 percent of its initial 200 priority accounts to establish workflows and enable TUDRIQEV adoption,1 and that leading melanoma institutions have rapidly placed TUDRIQEV on formulary and have started treating patients.1 The company also noted rapid and broad payer coverage facilitated by NCCN guideline inclusion, with TUDRIQEV listed in the NCCN Clinical Practice Guidelines in Oncology as a category 2A recommendation.1
On the regulatory front, Replimune stated that the melanoma indication is approved under accelerated approval based on objective response rate and duration of response, and continued approval may be contingent upon verification of clinical benefit in a confirmatory trial or trials.1 The company said its confirmatory study, IGNYTE-3, remains on track, with the global Phase 3 trial assessing TUDRIQEV in combination with nivolumab versus physician's choice in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment actively enrolling.1 Separately, the company said its registration-directed Phase 2/3 REVEAL trial of RP2 in metastatic uveal melanoma is actively enrolling, evaluating RP2 in combination with nivolumab versus ipilimumab in combination with nivolumab.1
On finances, Replimune reported cash and cash equivalents of $307.8 million as of September 30, 2026, compared to cash, cash equivalents and short-term investments of $268.9 million as of fiscal year ended March 31, 2026.1 The company said it expects existing cash and cash equivalents to fund operations for greater than twelve months from the issuance of the condensed consolidated financial statements, including the commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.