Recent Updates
Recently added Catalysts
REPL Negative Sentiment Score: 25/100

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. faces a class action lawsuit as investors seek to recover losses related to misleading statements about the IGNYTE trial for its lead candidate RP1. The lawsuit follows a Complete Response Letter from the FDA, which indicated that the agency could not approve the Biologics License Application due to inadequacies in the trial's design. Since the announcement, Replimune's stock has dropped significantly by over 77%. Investors have until September 22, 2025, to file a lead plaintiff motion to join the class action.

Market Sentiment Analysis

CONCERNS & RISKS

  • Replimune's stock price fell over 77% following a negative FDA response.
  • A class action lawsuit alleges misleading statements by the company.
  • The FDA determined the IGNYTE trial was inadequate and not well-controlled.
  • The company faces investor claims due to perceived corporate wrongdoing.

Full Press Release Details

Investors can contact the law firm at no cost to learn more about recovering their losses
LOS ANGELES, Sept. 09, 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
Attorney Advertising

Tags

Frequently Asked Questions

What is the deadline to file a motion for Replimune investors?

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

Who can investors contact for legal advice regarding Replimune?

Investors can contact attorney Lesley F. Portnoy at 310-692-8883 or via email.

What did the FDA say about Replimune's IGNYTE trial?

The FDA deemed the IGNYTE trial inadequate, resulting in a Complete Response Letter.

What allegations are in the Replimune class action lawsuit?

The lawsuit claims misleading statements about the IGNYTE trial's prospects.

How much has the Portnoy Law Firm recovered for investors?

The firm has recovered over $5.5 billion for investors affected by corporate wrongdoing.

Last updated: Sep 9, 2025