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PR inside: Replimune Group Stock Drops Significantly on News of FDA Complete Response ...

(PR-inside.com) PHILADELPHIA, PA / ACCESS Newswire / July 22, 2025 / Kehoe Law Firm, P.C. is investigating potential securities claims on behalf of investors ofReplimune Group, Inc. ("Replimune") (NASDAQ:REPL).

On July 22, 2025, Replimune announced that the FDA ". . . issued a Complete Response Letter (CRL) regarding the Biologics License Application . . . for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma."

The FDA's CRL, according to Replimune, ". . . indicates that the FDA is unable to approve the application in its present form. The FDA has indicated that the IGNYTE trial is not considered ..

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