REPL Stock Slumps 11% After-Hours — What’s Driving The Selloff?

Replimune said the U.S. Food and Drug Administration granted accelerated approval for TUDRIQEV, previously known as RP1, in combination with nivolumab.

• The approval follows two prior FDA rejections and a favorable advisory-committee vote last month.
• TUDRIQEV is an immunotherapy injected directly into tumors to help the immune system attack cancer cells.
• Confirmatory trials are underway, the company said.

Shares of Replimune (REPL) edged lower in after-hours trading on Thursday after the FDA granted accelerated approval to its melanoma therapy, contingent on a confirmatory late-stage trial for full clearance.

First Approval For TUDRIQEV

Replimune said the U.S. Food and Drug Administration granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec), previously known as RP1, in combination with nivolumab (Opdivo). It is authorized for adults with unresectable advanced cutaneous melanoma that progressed after treatment with an anti-PD-1 antibody-based regimen.

The green light rests on results from the IGNYTE trial. In the key group of patients, the combination produced a 24% response rate, with responses lasting a median of 14 months. Side effects were mostly mild to moderate. Continued approval depends on confirmatory studies still underway.

CEO Sushil Patel called it a transformative moment. “This marks years of pioneering research to bring TUDRIQEV to patients desperately in need of new treatment options for advanced melanoma,” he said.

Steps Ahead

TUDRIQEV is an immunotherapy injected directly into tumors to help the immune system attack cancer cells. It will be available through Replimune’s patient-support program for access and financial assistance.

Replimune first sought FDA clearance for TUDRIQEV (then called RP1) in late 2024. The agency rejected the application in July 2025, citing concerns that the supporting IGNYTE trial was not adequately controlled and that the patient population was too varied to clearly show the drug’s benefit.  

A resubmission in late 2025 led to a second rejection on April 10, 2026, for similar reasons—questions about whether the data proved TUDRIQEV itself contributed meaningfully beyond the accompanying checkpoint inhibitor.  The company then submitted a third application.

In late July, an FDA advisory committee voted 10-3 that the IGNYTE results were evaluable and clinically meaningful, clearing the way for this week’s accelerated approval.

How Did REPL Retail Traders React?

On Stocktwits, retail sentiment around REPL stock stayed ‘bearish,’ unchanged over the past 24 hours, while message volume remained at ‘extremely high’ levels.

A Stocktwits user voiced doubts about the company ever being profitable.

Another expressed concerns about the drug not getting full approval, and voiced doubts about the firm’s execution prowess. “Let them show they can actually sell it,” the user said.

REPL stock has gained 32% year-to-date. 

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