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Replimune Group, Inc. Investors: Please contact the Portnoy Law Firm to recover your losses. September 22, 2025 Deadline to file Lead Plaintiff Motion.

Key Takeaway: Replimune Group, Inc. is facing a class action lawsuit stemming from allegations that the company made misleading statements regarding its IGNYTE trial. Investors purchased securities between November 2024 and July 2025 and have until September 22, 2025, to file a lead plaintiff motion. The lawsuit follows the FDA's issuance of a Complete Response Letter stating it was unable to approve Replimune's Biologics License Application due to the inadequacy of the IGNYTE trial. Consequently, the company's stock suffered a significant drop of more than 77%.

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CONCERNS & RISKS

  • Replimune faces a class action lawsuit due to alleged misleading statements.
  • The FDA deemed the IGNYTE trial inadequate, impacting regulatory approval.
  • The stock price dropped over 77% following the negative FDA response.

Full Press Release Details

Investors can contact the law firm at no cost to learn more about recovering their losses
LOS ANGELES, Sept. 05, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Replimune Group, Inc. ("Replimune" or the "Company") (NASDAQ: REPL) investors of a class action representing investors that bought securities between November 22, 2024 and July 21, 2025, inclusive (the "Class Period"). Replimune investors have until September 22, 2025 to file a lead plaintiff motion.
Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 310-692-8883 or email: lesley@portnoylaw.com, to discuss their legal rights, or click here to join the case. The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors’ options for pursuing claims to recover their losses.
CASE ALLEGATIONS: Replimune is a clinical-stage biotechnology company focused on developing and commercializing oncolytic immunotherapies to treat cancer. Replimune’s lead product candidate is RP1 (vusolimogene oderparepvec), according to the complaint.
The Replimune class action lawsuit alleges that defendants made false and/or misleading statements and failed to disclose that they recklessly overstated the prospects of Replimune’s IGNYTE trial despite material issues that they knew or should have known, which ultimately led the U.S. Food and Drug Administration (“FDA”) to determine that the IGNYTE trial was inadequate and not well-controlled.
The complaint further alleges that on July 22, 2025, Replimune disclosed that the FDA had issued a Complete Response Letter (“CRL”) regarding the Biologics License Application (“BLA”) for RP1, stating it was “unable to approve the application in its present form” and finding that “the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.” On this news, the price of Replimune stock fell more than 77%.
Please visit our website to review more information and submit your transaction information.
The Portnoy Law Firm represents investors in pursuing claims against caused by corporate wrongdoing. The Firm’s founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.
Lesley F. Portnoy, Esq.
Admitted CA and NY Bar
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Frequently Asked Questions

How can Replimune investors recover their losses?

Investors can contact the Portnoy Law Firm for a free evaluation of their case.

What is the deadline to file a lead plaintiff motion?

Investors must file a lead plaintiff motion by September 22, 2025.

What is the Replimune class action about?

The lawsuit alleges that Replimune misled investors about the IGNYTE trial's prospects.

What caused Replimune's stock price drop?

The stock dropped after the FDA declared their IGNYTE trial inadequate.

Who can investors contact for legal rights discussion?

Investors can reach out to attorney Lesley F. Portnoy via phone or email.

Last updated: Sep 5, 2025