A class action lawsuit was filed against Replimune Group (REPL) by Levi & Korsinsky on July 24, 2025. The plaintiffs (shareholders) alleged that they bought REPL stock at artificially inflated prices between November 22, 2024, and July 21, 2025 (Class Period) and are now seeking compensation for their financial losses. Investors who bought Replimune stock during that period can click here to learn about joining the lawsuit.
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Replimune is a clinical-stage biotechnology company focused on developing cancer treatments using a new class of oncolytic immunotherapies designed to activate a powerful and durable systemic anti-tumor response.
The company’s lead drug candidate, RP1 (vusolimogene oderparepvec), is a modified herpes virus engineered with a tumor-killing protein and an immune-boosting factor (GM-CSF). RP1 is designed to kill cancer cells more effectively and trigger a stronger immune response against tumors.
Replimune’s claims about the efficacy and prospects of the IGNYTE trial, which is studying RP1 in combination with nivolumab for advanced melanoma, are at the heart of the current complaint.
Replimune’s Misleading Claims
According to the lawsuit, Replimune and two of its senior officers (the Defendants) repeatedly made false and misleading public statements throughout the Class Period. In particular, they are accused of omitting truthful information about the IGNYTE trial’s prospects from SEC filings and related material.
During the Class Period, the defendants kept reiterating the positive prospects of the ongoing IGNYTE trial. For instance, in a press release, Replimune announced that RP1 received Breakthrough Therapy designation based on safety and clinical results from the IGNYTE trial in melanoma patients who had not responded to anti-PD-1 therapy.
Later, in its February 12, 2025 SEC filing, Replimune highlighted the IGNYTE trial, a multi-cohort clinical trial being conducted in collaboration with Bristol Myers Squibb (BMY), noting that its main focus is a Phase 2 study of RP1 in patients with cutaneous melanoma who did not respond to anti-PD-1 therapy.
Finally, in its May 22, 2025 annual report, Replimune said the U.S. Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA), granted priority review with a July 22, 2025 decision date, and confirmed that reviews and inspections were completed, keeping the process on track.
However, subsequent events (detailed below) reveal that the defendants failed to inform investors about material issues related to the IGNYTE trial.
Plaintiffs’ Arguments
The plaintiffs maintain that the defendants deceived investors by lying and withholding critical information about the company’s business practices and prospects during the Class Period. Importantly, the defendants are accused of misleading investors about the true prospects of the IGNYTE trial.
The information became clear before the markets opened on July 22, 2025, when Replimune issued a press release announcing the receipt of a Complete Response Letter (CRL) from the FDA for its RP1 BLA for the Treatment of Advanced Melanoma.
The company noted that the CRL indicated the FDA has not approved the BLA as submitted. The FDA found the IGNYTE trial insufficient and inadequate to prove effectiveness. Replimune added that it plans to request a Type A meeting within 30 days to discuss next steps. Following the news, REPL stock collapsed by 77.2% the same day.
To conclude, the defendants failed to inform investors about the material issues with the IGNYTE trial, which could prompt the FDA to deem the trial inadequate and not well-controlled. Due to these issues, REPL stock has lost 51.3% so far this year.
