New York, May 29, 2026, 14:02 (EDT)
Replimune Group shares rallied Friday afternoon. The company said it reached a deal with the U.S. Food and Drug Administration to resubmit RP1, its experimental advanced melanoma drug. Shares jumped $3.96, or roughly 85%, to $8.64 after hitting $9.05. The SPDR S&P Biotech ETF added about 0.8%.
The surge gives the Woburn, Massachusetts biotech a new shot in the market just weeks after regulators rejected the drug again. The trade now moves from failed approval worries to questions around when the filing lands, how the FDA reviews it, and what evidence the agency may take this time.
Replimune plans to file its Biologics License Application again in the next few days. The FDA told the company it will give the new submission priority review, citing the unmet need in advanced melanoma.
Replimune CEO Sushil Patel said in a statement, “We are grateful to the FDA leadership” as the agency works with the company on next steps for RP1. The therapy, known as vusolimogene oderparepvec, is an oncolytic immunotherapy that uses a modified virus to target cancer cells and help the immune system respond. Replimune Group Inc.
The FDA turned down the therapy in April, Reuters said, pointing to Replimune’s use of just a single-arm study with no control group. The agency told the company it wanted stronger data from a well-controlled trial. Replimune is testing RP1 together with nivolumab, the generic for Bristol Myers Squibb’s Opdivo, in patients with advanced melanoma.
The shift isn’t being counted as full approval risk. “We see this as a positive, but remain cautious,” BMO Capital analyst Evan Seigerman told Reuters. He said he was unsure what was different aside from the FDA leadership. Reuters
Replimune took a blow in April when the FDA turned down the drug, though the company said its IGNYTE trial had shown a 34% response rate and a median response lasting 24.8 months for people getting RP1 with nivolumab after anti-PD-1 therapy didn’t work. Anti-PD-1 drugs aim to help the immune system spot tumors.
Bristol Myers works with the drug Opdivo in a narrow but key field. Iovance Biotherapeutics is in the mix with Amtagvi, its approved treatment for advanced melanoma. Reuters said last month that a rejection for Replimune eased the competitive pressure on Iovance. On Friday, Bristol Myers lost about 0.6%. Iovance dropped around 6.5%.
Replimune will soon report more data. The company is expected to share three-year overall survival data from IGNYTE at the American Society of Clinical Oncology meeting on May 30, and will present a poster for its Phase 3 IGNYTE-3 study on May 31.
But the risk is still clear: moving up in the FDA review does not mean approval. If the FDA presses on the trial setup again or asks for more randomized trial evidence before signing off on RP1, shares could lose ground as fast as they gained it Friday. The bounce was tied to the process, not to any fresh clinical results.
Right now, investors are buying back in after the door reopened. What comes next: Replimune still has to turn the FDA’s urgency into a filing, get a review clock started, and see if the agency makes a different call than its last two decisions.
