Replimune (REPL) stock underwent a major rally on Monday after the biotechnology company announced results from its resubmission of a Biologics License Application (BLA) for “RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.” Melanoma is a tumor of melanin-forming cells and is a type of skin cancer.
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Replimune noted that the U.S. Food and Drug Administration (FDA) accepted its resubmission of the BLA and has set a PDUFA date of April 10, 2026. The biotechnology company has worked over the past few months to address feedback from the FDA on its initial BLA submission. As a result, it included additional information, data, and analyses in the resubmission. It considers this a complete response to the FDA’s complete response letter sent in July 2025.
Replimune CEO Sushil Patel said, “We are pleased the agency has accepted the resubmission of our BLA for RP1. RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit.”
Replimune Stock Movement Today
Replimune stock was up 104% in pre-market trading on Monday, following a 3.64% drop on Firday. The shares have fallen 62.84% year-to-date and 60.35% over the past 12 months. Today’s news came with heavy trading, as some 51 million shares changed hands, compared to a three-month daily average of about 4.13 million units.
Is Replimune Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Replimune is Hold, based on two Buy, five Hold, and two Sell ratings over the past three months. With that comes an average REPL stock price target of $3.83, representing a potential 14.89% downside for the shares.
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