Replimune Group, Inc.(NASDAQ: REPL) Securities Fraud Class Action

The Replimune Group, Inc. securities fraud class action lawsuit was filed on behalf of those who purchased or otherwise acquired Replimune Group, Inc. (“Replimune”) (NASDAQ: REPL) securities between October 20, 2025 and April 10, 2026, inclusive (the “Class Period”). Captioned Ramn Toor v. Replimune Group, Inc., No. 26-cv-13612 (D. Mass.), the Replimune class action lawsuit alleges that Replimune and/or certain of its officers and/or directors violated federal securities laws by making false or misleading statements and/or omitted to disclose material information.

If you lost money as a result of your Replimune investment and want to find out more about this action and your rights, fill out the form on this page or contact attorney Jonathan Naji, Esq. of KTMC by calling (484) 270-1453 or via e-mail at [email protected].

COMPLAINT ALLEGATION SUMMARY:
Replimune is a biotechnology company focused on novel oncolytic immunotherapies, which utilize viruses to destroy cancer cells. The company’s lead product candidate, RP1, has been undergoing clinical trials, with its leading trial being referred to as the IGNYTE trial. On October 20, 2025, Replimune announced that the U.S. Food and Drug Administration (“FDA”) had accepted its resubmitted Biologics License Application (“BLA”) for RP1 in combination with another drug called nivolumab. The October submission was said to be “a complete response to the complete response letter received in July 2025,” in which the FDA found deficiencies in Replimune’s prior BLA.

The complaint alleges that, throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material facts about the company’s business, operations, and prospects. Specifically, Defendants misrepresented and/or failed to disclose that: (1) the FDA’s concerns with the IGNYTE study design from July 2025 were not addressed in connection to the resubmitted BLA; (2) data submitted by Replimune replied on an early, unplanned analysis with only 10% of the planned patient enrollment included; (3) consequently, the clinical trial results had deficiencies that were likely to cause the FDA to reject the resubmitted BLA; and (4) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

WHY DID REPLIMUNE’S STOCK DROP?
During market trading on April 10, 2026, the FDA published a Complete Response Letter rejecting Replimune’s BLA for RP1 due to deficiencies in the trial and subsequent evidence of effectiveness. The FDA revealed that it had “clearly communicated” its concerns with the study design throughout Replimune’s development program, yet Replimune failed to address those concerns. On this news, the price of Replimune’s stock fell more than 19%.

Then, after the market closed on April 10, 2026, Replimune issued a press release conceding that the FDA had previously expressed that “a randomized controlled trial was preferred,” but that the FDA also 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 continued to fall more than 64% per share by close on April 13, 2026.

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 a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP:
Kessler Topaz Meltzer & Check, LLP (KTMC) is a leading U.S. plaintiff-side law firm focused on securities-fraud class actions and global investor protection. The firm represents individual investors as well as institutions, such as major pension funds, asset managers, and international investors. KTMC has led some of the largest recoveries in securities litigation and has been recognized by peers and the legal media with numerous accolades, including The National Law Journal’s Plaintiff’s Hot List and Trailblazers in Plaintiffs’ Law, BTI Consulting Group’s Honor Roll of Most Feared Law Firms, The Legal Intelligencer’s Class Action Firm of the Year, Lawdragon’s Leading Plaintiff Financial Lawyers, and Law360’s Titans of the Plaintiffs Bar. The firm operates globally with offices in Pennsylvania and California. KTMC has recovered over $25 billion for our clients and the classes they represent.