Replimune Wins FDA Approval for TUDRIQEV Melanoma Therapy

The Tip Desk · August 14, 2026 · 3 min read

Cash, cash equivalents and short-term investments were $195.3 million at June 30, 2026, before a $150 million August financing that the company said will fund operations for greater than twelve months.

Replimune Group, Inc. (REPL), a commercial-stage biotechnology company developing oncolytic immunotherapies, said the U.S. Food and Drug Administration granted accelerated approval on August 6, 2026, for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who experienced disease progression with a PD-1 antibody-based regimen.

The company began U.S. launch preparations and anticipated having product in the market within 60 days. Continued approval of the indication may be contingent on verification of clinical benefit in a confirmatory trial.

Two months earlier, Replimune had still described itself as a clinical-stage company, with the RP1 biologics license application resubmission accepted for review and a PDUFA goal date of August 2, 2026. The August 6 decision converted that pending review into an approved product and a commercial posture. Chief Executive Officer Sushil Patel said the approval was a defining milestone and that the company was now a fully integrated biotechnology company completing the build-out of commercial infrastructure.

Replimune appointed Michelle DiNapoli as Chief Commercial Officer, effective August 18, 2026. She brings more than 25 years of biopharmaceutical experience, including seven years at Deciphera Pharmaceuticals, where she built the U.S. sales force and led the U.S. commercial organization.

The global Phase 3 IGNYTE-3 trial of RP1 plus nivolumab versus physician’s choice in advanced melanoma patients who have progressed on anti-PD-1 and anti-CTLA-4 therapies, or are ineligible for anti-CTLA-4 treatment, is actively enrolling. The primary endpoint is overall survival, expected to read out in 2030; key secondary endpoints are progression-free survival and overall response rate. That trial is the confirmatory study tied to the accelerated approval.

RP2, which additionally expresses an anti-CTLA-4 antibody-like molecule, is in the REVEAL registration-directed Phase 2/3 trial in metastatic uveal melanoma, evaluating RP2 plus nivolumab versus ipilimumab plus nivolumab in approximately 280 patients. A Phase 2/3 transition is expected in the first quarter of 2027.

For the fiscal first quarter ended June 30, 2026, Replimune reported a net loss of $69.8 million, or $0.72 a share, versus $86.7 million, or $0.95 a share, a year earlier. Total operating expenses were $68.2 million.

Research and development expenses were $49.3 million, down from $57.8 million a year earlier. The decrease primarily reflected lower personnel-related and other costs and lower direct research costs on the IGNYTE, ARTACUS and CERPASS studies. R&D included $3.6 million of stock-based compensation.

Selling, general and administrative expenses were $19.0 million, versus $32.6 million a year earlier, and included $4.1 million of stock-based compensation.

Cash, cash equivalents and short-term investments were $195.3 million as of June 30, 2026, down from $268.9 million as of March 31, 2026. The decline reflected cash burn related to operating activities in advancing clinical development plans. Working capital was $162.4 million, total assets were $252.4 million and stockholders’ equity was $105.6 million.

After quarter-end, Replimune completed a $150 million financing, including $141.0 million of net proceeds from an August 2026 common-stock issuance, to support the commercial launch of TUDRIQEV and the ongoing IGNYTE-3 confirmatory trial. Based on its current operating plan, existing cash as of June 30, 2026, plus those net proceeds will enable it to fund operations for more than twelve months from the issuance of the condensed consolidated financial statements, including scale-up for commercialization of TUDRIQEV in advanced melanoma and for working capital and general corporate purposes.

TUDRIQEV is a genetically modified herpes simplex virus type 1 oncolytic therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus and human GM-CSF. It preferentially replicates within the tumor, and in the anti-PD-1-resistant setting, TUDRIQEV and nivolumab in combination may promote an antitumor immune response.