NEW YORK CITY, NY / ACCESS Newswire / July 31, 2025 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Replimune Group, Inc. ("Replimune" or "the Company") (NASDAQ:REPL). Investors who purchased Replimune securities are encouraged to obtain additional information and assist the investigation by visiting the firm’s site: bgandg.com/REPL.
Investigation Details
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.
What’s Next?
If you are aware of any facts relating to this investigation or purchased Replimune securities, you can assist this investigation by visiting the firm’s site: bgandg.com/REPL. You can also contact Peretz Bronstein or his client relations manager, Nathan Miller, of Bronstein, Gewirtz & Grossman, LLC: 332-239-2660
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Contact
Bronstein, Gewirtz & Grossman, LLC
Peretz Bronstein or Nathan Miller
332-239-2660 | info@bgandg.com
SOURCE: Bronstein, Gewirtz & Grossman, LLC
View the original press release on ACCESS Newswire
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