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Replimune Group, Inc.

Securities Class Action

  • Date:
  • 7/23/2025
  • Status:
  • Investigating

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Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ:REPL) on behalf of Replimune stockholders. Our investigation concerns whether Replimune has violated the federal securities laws and/or engaged in other unlawful business practices.

On July 22, 2025, Replimune issued a press release "announcing 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.
If you purchased or otherwise acquired Replimune shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com, by telephone at (212) 355-4648, or by filling out the form below.  There is no cost or obligation to you.
Contact Instructions
Please contact Brandon Walker or Marion Passmore by email at investigations@bespc.com with any questions regarding the case.
The individual or institution below (“Plaintiff”) has reviewed and agrees to the Bragar Eagel & Squire, P.C. (“BESPC”) retainer agreement and authorizes BESPC to prosecute an action on Plaintiff’s behalf under the federal securities laws or applicable state laws to recover damages on behalf of investors in . BESPC will prosecute the action on a full contingency basis and will forward all costs and expenses.
 

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