Case Background:
This is a federal securities fraud class action lawsuit on behalf of those who purchased or otherwise acquired Replimune Group, Inc., (“Replimune”) (NASDAQ: REPL) securities between November 22, 2024 and July 21, 2025, inclusive (the “Class Period”).
Replimune is a clinical-stage biotech company focused on cancer treatments and immunotherapies.
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) the trial prospects for IGNYTE, Replimunes’ proposed combination-treatment for skin cancer, were overstated; (2) resulting in the FDA deeming the trial inadequate and not well-controlled; and (3) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects were materially false and/or misleading and/or lacked a reasonable basis at all relevant times.
Current Status of Case:
On November 14, 2025, the Court appointed Lead Plaintiff and Lead Counsel. This action is ongoing.
If you wish to discuss this action or have any questions, please contact Kessler Topaz Meltzer & Check, LLP: Jon Naji, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.