NEW YORK CITY, NY / ACCESS Newswire / July 28, 2025 / Pomerantz LLP is investigating claims on behalf of investors of Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ:REPL). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980.
The investigation concerns whether Replimune and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
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On July 22, 2025, Replimune issued a press release "announc[ing] that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma." Per the press release, "[t]he CRL 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 to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness. Furthermore, the FDA said the trial cannot be adequately interpreted due to the heterogeneity of the patient population. The CRL also states that there are items related to the confirmatory trial study design which need to be addressed, including contribution of components. Importantly, no safety issues were raised."
On this news, Replimune’s stock price fell $9.52 per share, or 77.24%, to close at $2.81 per share on July 22, 2025.
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SOURCE: Pomerantz LLP
View the original press release on ACCESS Newswire
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