Replimune Group, Inc. Class Action Lawsuit - REPL
Case Summary
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The Replimune class action lawsuit seeks to represent purchasers or acquirers of Replimune Group, Inc. (NASDAQ: REPL) securities between October 20, 2025 and April 10, 2026, inclusive (the “Class Period”). Captioned Toor v. Replimune Group, Inc., No. 26-cv-13612 (D. Mass.), the Replimune class action lawsuit charges Replimune and certain of Replimune’s top executive officers with violations of the Securities Exchange Act of 1934.
If you suffered substantial losses and wish to serve as lead plaintiff of the Replimune class action lawsuit, please provide your information in the form on this page. You can also contact attorneys Ken Dolitsky or Michael Albert of Robbins Geller by calling 800/851-7783 or via e-mail at info@rgrdlaw.com. Lead plaintiff motions for the Replimune class action lawsuit must be filed with the court no later than October 5, 2026.
CASE ALLEGATIONS: Replimune is a clinical-stage biotechnology company that focuses on the development and commercialization of oncolytic immunotherapies to treat cancer. According to the complaint, Replimune’s lead product candidate is RP1 (vusolimogene oderparepvec).
On October 20, 2025, Replimune allegedly published a press release announcing that the U.S. Food and Drug Administration (“FDA”) had accepted the resubmission of the Biologics License Application (“BLA”) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen. The complaint alleges that Replimune also claimed that “[d]uring the past few months, Replimune has been working to address agency feedback,” that “[a]dditional information, data and analyses were included in the resubmission which will be part of the BLA review,” and that “[t]he FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.”
The Replimune class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) in connection with the BLA, the study design concerns previously communicated by the FDA were not addressed; (ii) Replimune had submitted data from an early unplanned analysis from RP1-104, which included only 40 patients (10% of the planned enrollment of 400 patients); (iii) as a result, RPL-001-16 and RP1-104 both had deficiencies which were likely to cause the FDA to reject the BLA; and (iv) as a result of the foregoing, defendants’ positive statements about Replimune’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
On April 10, 2026, the FDA allegedly published a Complete Response Letter rejecting Replimune’s BLA for RP1 in connection with nivolumab. According to the complaint, 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 allegedly 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. The complaint further alleges that the FDA disclosed it had “clearly communicated” its “concerns with the study design in multiple FDA interactions throughout [Replimune’s] development program,” but that “the study design concerns previously communicated were not addressed, and the contribution of [RP1] to the observed response rate in RPL-001-16 could not be determined.” On this news, Replimune’s share price fell more than 19% before trading was halted, according to the complaint.
Later that same day, after the market closed, Replimune allegedly issued a press release discussing the FDA’s response letter for the RP1 BLA. The Replimune class action lawsuit further alleges that in the press release, Replimune conceded that “a randomized controlled trial was preferred” by the FDA, but also claimed 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 share price dropped over 64%, according to the complaint.
THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased or acquired Replimune securities during the Class Period to seek appointment as lead plaintiff in the Replimune class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Replimune class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Replimune class action lawsuit. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Replimune class action lawsuit.
ABOUT ROBBINS GELLER: Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities fraud and shareholder rights litigation. Our Firm ranked #1 on the most recent ISS Securities Class Action Services Top 50 Report, recovering more than $916 million for investors in 2025. This marks our fourth #1 ranking in the past five years. And in those five years alone, Robbins Geller recovered $8.4 billion for investors – $3.4 billion more than any other law firm. With 200 lawyers in 10 offices, Robbins Geller is one of the largest plaintiffs’ firms in the world, and the Firm’s attorneys have obtained many of the largest securities class action recoveries in history, including the largest ever – $7.2 billion – in In re Enron Corp. Sec. Litig.