REPL SHAREHOLDER ALERT: Securities Fraud Lawsuit Filed on Behalf of Replimune Group, Inc. Investors - Contact Kirby McInerney LLP by October 5, 2026

NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Kirby McInerney LLP reminds investors who purchased Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ: REPL) securities to 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 in the securities fraud class action lawsuit at no cost.

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. The lead plaintiff oversees the litigation on behalf of the class and may influence key decisions, including litigation strategy and settlement. Courts regularly appoint individual investors as lead plaintiffs, not only institutions. Learn more about the lead plaintiff process and eligibility requirements here.

Follow the link below for more information about the lawsuit:

[CONTACT THE FIRM IF YOU SUFFERED A LOSS]

What Is The Lawsuit About?

The lawsuit has been filed on behalf of investors who purchased securities during the period of October 20, 2025 and April 10, 2026, inclusive (“the Class Period”). 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.

[CLICK HERE TO LEARN MORE ABOUT THE CLASS ACTION]

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.

[HOW CAN I PROTECT MY RIGHTS?]

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.

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Contacts
Kirby McInerney LLP        
Lauren Molinaro, Esq.
212-699-1171
https://www.kmllp.com
https://securitiesleadplaintiff.com/
investigations@kmllp.com