Replimune's TUDRIQEV Wins FDA Accelerated Approval for Advanced Melanoma After Two Rejection Letters — Then Raises $150 Million

The FDA granted accelerated approval on August 6, 2026, to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune Inc.; NASDAQ: REPL) in combination with nivolumab for adult patients with unresectable advanced cutaneous melanoma who progressed on a prior PD-1-blocking antibody regimen. The approval is the first for an oncolytic virus therapy since Amgen's talimogene laherparepvec (T-VEC) in 2015.

Replimune first filed a biologics license application on November 22, 2024. The FDA rejected it on July 21, 2025, citing a lack of substantial evidence of effectiveness tied in part to heterogeneity in the patient population, per the FDA's approval announcement. A second complete response letter followed on April 10, 2026. Final approval came four days after the August 2, 2026, PDUFA target date — which fell on a Sunday.

The Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 to recommend approval.

Efficacy was evaluated in the IGNYTE trial (NCT03767348), an open-label, single-arm study in 140 adult patients 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, the combination achieved an objective response rate of 24.2%, with a median duration of response of 14.1 months. The enrolled population was 80% Stage 4, 54% PD-L1-negative, and 13% had prior anti-PD-1 adjuvant treatment.

On safety, serious adverse reactions occurred in 35% of patients, and 2.9% discontinued permanently due to adverse reactions. The FDA noted no grade 4 or 5 common adverse events, with most reactions characterized as mild to moderate.

Accelerated approval carries a condition: Replimune must conduct post-approval trials to verify clinical benefit, per the FDA's approval announcement. That vehicle is the ongoing Phase 3 IGNYTE-3 trial, which randomizes approximately 400 patients to RP1 plus nivolumab against physician's choice — nivolumab plus relatlimab, anti-PD-1 rechallenge, or single-agent chemotherapy — with overall survival as the primary endpoint and data expected in 2030.

"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, PhD, CEO of Replimune, in a company press release.

The company moved quickly to capitalize on the approval. On August 10, 2026, Replimune priced an underwritten public offering of 9,701,490 shares at $12.06 per share, plus pre-funded warrants to purchase 2,736,340 additional shares at $12.0599 per warrant for certain investors, expecting approximately $150 million in gross proceeds before discounts and expenses, per Investing.com.

Analyst upgrades followed the approval. Leerink raised Replimune to Outperform from Market Perform, lifting its price target to $17 from $11. Piper Sandler analyst Allison Bratzel upgraded the stock to Overweight from Neutral with a price target of $14, up from $9. As of August 14, 2026, the stock carried a market cap of $426.40 million and a 52-week high of $17.00, though insider selling activity was reported during the August 11–18, 2026, period.

On the earnings side, Replimune reported Q1 2026 EPS of ($0.95), missing the consensus estimate of ($0.85) by ($0.10).

The broader small-cap backdrop is complicated heading into September. The Russell 2000 fell 1.5% for the week ended August 28, 2026, and dropped 1.4% on Friday alone, per STL News, even as large-cap benchmarks remained positive for the week. Markets on August 28 were pricing roughly a 57% probability of a rate increase, with the federal funds rate currently at 3.50% to 3.75%, per iShares. The August U.S. employment report is scheduled for September 4 and is expected to influence expectations for the Fed's September 15–16 FOMC meeting.

As a condition of the accelerated approval, Replimune must conduct post-approval trials to verify and describe Tudriqev's clinical benefit, per the FDA's approval announcement. IGNYTE-3's overall survival readout, expected in 2030, is the designated confirmatory trial for that requirement.