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Press Release
hsmith@howardsmithlaw.comThis investigation is for anyone who acquired securities in Replimune Group, Inc. (NASDAQ: REPL) from October 20, 2025 through July 28, 2026.
The Law Offices of Howard G. Smith believes that the Company and certain of its executives violated federal law. Specifically, the Law Offices of Howard G. Smith believes that, throughout the time period mentioned above, the Company misled investors regarding its financial condition. More specifically, the Law Offices of Howard G. Smith believes 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 July 28, 2026, the US Food and Drug Administration (“FDA”) released briefing documents related to Replimune’s lead trial for its drug vusolimogene oderparepvec, or RP1, for skin cancer. The briefing documents state the FDA has deemed the single-arm mid-stage study submitted by Replimune to support the approval of the drug as “not interpretable.” The assessment used in the study “confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results,” the FDA reviewers said. 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 July 28, 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.
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