| COMPANY |
Replimune Group, Inc. |
| COURT |
United States District Court for the District of Massachusetts |
| CASE NUMBER |
1:25-cv-12085 |
| JUDGE |
The Hon. Julia E. Kobick |
| CLASS PERIOD |
November 22, 2024 through July 21, 2025 |
| SECURITY TYPE |
Securities |
LEAD PLAINTIFF DEADLINE IS SEPTEMBER 22, 2025.
If you have suffered losses and would like to discuss your rights, please fill out this form or you may contact Jonathan Naji, Esq. at (484) 270-1453 or via e-mail at info@ktmc.com.
Case Background:
A class action lawsuit was filed on behalf of those who purchased or otherwise acquired Replimune Group, Inc., (“Replimune”) (NASDAQ: REPL) publicly traded securities between November 22, 2024, and July 21, 2025, inclusive (the “Class Period”).
The Class Period begins on November 22, 2024. The day before, on November 21, 2024, Replimune issued a press release touting that the company’s lead product candidate, RP1 (vusolimogene oderparepvec), a proprietary strain of herpes simplex virus engineered to maximize tumor killing potency, was granted a Breakthrough Therapy designation by the FDA. Replimune also announced that it had submitted a Biologics License Application (“BLA”) under the Accelerated Approval pathway, seeking approval for RP1 in combination with nivolumab for treatment of adult patients with advanced melanoma who previously received an anti-PD1 containing regimen (the “IGNYTE trial”).
On July 22, 2025, before the market opened, Replimune announced that the company received a Complete Response Letter (“CRL”) from the FDA for RP1 denying the BLA in its present form, finding that the IGNYTE trial was “not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness,” and that the trial could not be “adequately interpreted due to the heterogeneity of the patient population.” Furthermore, the CRL stated that items related to the confirmatory trial study design needed to be addressed, including contribution of components. On this news, the price of Replimune common stock declined $9.52 per share, or approximately 77.24%, from a close of $12.325 per share on July 21, 2025, to close at $2.805 per share on July 22, 2025.
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) Replimune overstated the IGNYTE trial’s prospects; and (2) as a result, 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.
What is a Lead Plaintiff?
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.