Replimune Group, Inc. (NASDAQ: REPL)

This lawsuit is for anyone who acquired securities in Replimune Group, Inc. (NASDAQ: REPL) from October 20, 2025 through April 10, 2026.

The lawsuit alleges that the Company and certain of its executives violated federal law. Specifically, the lawsuit alleges that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the lawsuit alleges that the Company misled investors by making positive statements about the prospects for the Company’s skin cancer drug, vusolimogene oderparepvec, to gain FDA approval while conducting clinical trials in such a way as to make the data obtained from the trials uninterpretable and FDA approval unlikely.

On April 10, 2026, during market trading, the FDA published a Complete Response Letter (“CRL”) rejecting Replimune’s Biologics License Application (“BLA”) for RP1 in combination with nivolumab. The FDA identified several deficiencies for each of the studies—RPL-001-16 (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.” The FDA further revealed that “[t]o support resubmission of the BLA on October 9, 2025, [Replimune] provided [objective response rate] data from an early unplanned analysis” from RP1-104 which included only 40 patients, 10% of the planned enrollment of 400 patients. On this news, the price of the Company’s stock dropped precipitously on unusually heavy trading volume.

The Law Offices of Howard G. Smith seeks to recover damages on behalf of class members. If you acquired securities in Replimune Group, Inc. (NASDAQ: REPL) from October 20, 2025 through April 10, 2026 you may join the lawsuit by submitting your information online, or you may call the Law Offices of Howard G. Smith and speak to Mr. Smith directly to learn how he can protect your rights.