The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) common stock between October 20, 2025 and April 10, 2026, inclusive (“the Class Period”).

If you suffered a loss on your Replimune investments, you have until October 5, 2026 to request lead plaintiff appointment. Courts do not consider lead plaintiff applications submitted after this deadline. If you choose to take no action, you may remain an absent class member. For more information about the lawsuit:

[CONTACT THE FIRM IF YOU SUFFERED A LOSS]

What Is This Lawsuit About? The lawsuit alleges that Replimune made materially false and/or misleading statements and failed to disclose to investors that: (i) in connection with the Biologics License Application (“BLA”) for the Company’s lead product candidate, RP1, the study design concerns previously communicated by the FDA were not addressed; (ii) the Company had submitted data from an early unplanned analysis from RP1-104, which included only 40 patients (10% of the planned enrollment of 400 patients); and (iii) as a result, RPL-0001-16 and RP1-104 had deficiencies, which were likely to cause the FDA to reject the BLA.

On April 10, 2026, the FDA published a Complete Release Letter rejecting Replimune’s BLA for RP1 in combination with nivolumab. The FDA identified several deficiencies in the studies—RPL-0001-16 (IGNYTE) and RP1-104 (IGNYTE-3)—submitted by Replimune and found that “the evidence as presented does not meet the evidentiary standards required for regulatory approval, and the results of the additional exploratory analyses of the RPL-001-16 data do not alter our initial conclusion that the RPL-001-16 trial is not an adequate and well-controlled clinical investigation that demonstrates substantial evidence of effectiveness.” Additionally, the FDA asserted that Replimune “submitted data from an early unplanned analysis from RP1-104 representing 10% of the planned enrollment.” The FDA stated it had “clearly communicated” its “concerns with the study design in multiple FDA interactions throughout [Replimune’s] development program,” but “the study design concerns previously communicated were not addressed.” On this news, Replimune’s stock price fell $1.15, or 19.46%, to close at $4.76 per share on April 10, 2026.

After the market closed on April 10, 2026, the Company issued a press release, stating that “a randomized controlled trial was preferred” by the FDA but claiming that the FDA communicated that “if the data was sufficiently compelling, a single arm trial could be acceptable for consideration under accelerated approval.” On this news, Replimune’s stock price fell a further $3.60, or 64.29%, to close at $1.70 per share on April 13, 2026.

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The Lead Plaintiff Appointment Process. The federal securities laws permit any investor who acquired eligible securities during the class period to seek appointment as lead plaintiff in a class action lawsuit. Learn more about the lead plaintiff process and eligibility requirements here. Courts typically appoint the investor(s) with the largest financial loss in the case and the ability to represent the class rather than investors with simply the largest investment portfolio. Courts regularly appoint individual investors, whether acting alone or as a group, as lead plaintiffs. The rights of any investor who bought shares during the class period are generally already protected. However, lead plaintiffs have the power to influence case strategy and have a say in settlement decisions, as well as decisions concerning allocation of settlement funds among class members.

[LEARN MORE ABOUT THE LEAD PLAINTIFF PROCESS]

What Should I Do? If you purchased or otherwise acquired Replimune securities, have information, or would like to learn more about this investigation, please contact Lauren Molinaro of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below, to discuss your rights or interests with respect to these matters at no cost.

Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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