Replimune (REPL) stock plummeted on Tuesday after the biotechnology company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). The FDA didn’t approve the Biologics License Application (BLA) for RP1 in combination with nivolumab as a treatment for advanced melanoma. Advanced melanoma occurs when the cancer spreads beyond the skin, such as to the lymph nodes, distant organs, or bones.
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Replimune CEO Sushil Patel said, “We are surprised by this FDA decision and disappointed for advanced melanoma patients who have limited treatment options as highlighted by the granting of breakthrough status at the time we provided the IGNYTE primary data.”
Replimune intends to request a Type A meeting with the FDA to seek a timely and accelerated approval of RP1. It expects this meeting to be granted within the next 30 days.
Replimune Stock Movement Today
Replimune stock was down 76.88% in pre-market trading on Tuesday, following a 1.94% rally yesterday. The company’s shares have rallied 1.78% year-to-date and 22.76% over the past 12 months. Today’s drop came with heavy trading, as some 10 million shares changed hands, compared to a three-month daily average trading volume of 1.63 million shares.
Is Replimune Stock a Buy, Sell, or Hold?
Turning to Wall Street, the analysts’ consensus rating for Replimune is Strong Buy, based on nine Buy ratings over the past three months. With that comes an average REPL stock price target of $22.43, representing a potential 81.99% upside for the shares.
