Replimune's Tudriqev Wins FDA Accelerated Approval After Two Rejections — 24.2% ORR, $450K List Price, $140.5M Raise Closes

Replimune Group (NASDAQ: REPL) cleared its hardest regulatory hurdle on August 6, 2026: FDA accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma who progressed on an anti-PD-1 antibody-based regimen. It took three submissions and two complete response letters to get there.

The approval makes Tudriqev the first oncolytic immunotherapy to reach the US market in this setting, and it enters a space currently occupied by exactly one competitor. Iovance Biotherapeutics' Amtagvi — a cell therapy that received its own accelerated approval in 2024 — posted $220 million in 2025 sales for the same indication, per Replimune's company release.

The pivotal data come from IGNYTE (NCT03767348), an open-label, single-arm, multiregional trial in 140 adults with Stage IIIB, IIIC, or IV unresectable advanced melanoma who had progressed after at least eight consecutive weeks of prior anti-PD-1-based therapy. In the efficacy-evaluable population of 91 patients with at least one non-injected lesion, Tudriqev plus nivolumab produced an objective response rate of 24.2%, with a median duration of response of 14.1 months, according to the FDA's approval notice.

The accelerated pathway means continued approval is contingent on verification of clinical benefit in a confirmatory trial. That trial is already enrolling: a Phase 3 study targeting 400 patients with overall survival as the primary endpoint. Data are expected in 2030.

On July 30, 2026, the FDA convened its Cellular, Tissue, and Gene Therapies Advisory Committee to discuss the application, including a public hearing with patients, advocates, clinicians, and independent experts. The FDA had set a target decision date of August 2, 2026, after accepting the third resubmission; the approval came four days later.

"This is a transformative moment for Replimune, marking years of pioneering research to bring TUDRIQEV to patients desperately in need of new treatment options for advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune, in the company's August 6 news release.

Replimune priced Tudriqev at $450,000 per course of therapy before customary rebates and discounts.

The company moved quickly to fund the commercial launch. On August 9, 2026, Replimune entered into an underwriting agreement with Leerink Partners, J.P. Morgan, and Cantor Fitzgerald for an underwritten offering of 9,701,490 shares of common stock priced at $12.06 per share and pre-funded warrants to purchase 2,736,340 shares priced at $12.0599 per warrant. Gross proceeds are approximately $150 million; net proceeds are estimated at about $140.5 million. The transaction was expected to close August 11, 2026, per the company's release.

The stock's 52-week range of $2.68 to $17.00 frames how much ground the company has covered — and how much uncertainty the two prior CRLs injected into the equity.

What's next is well-defined: commercial execution against Iovance's Amtagvi, confirmatory Phase 3 enrollment toward a 400-patient target, and an overall survival readout expected in 2030. The accelerated approval is the floor; full approval depends on that trial.