Replimune Group Inc.

Company: Replimune Group Inc.
Ticker: REPL
Class Action Period: October 20, 2025 – April 10, 2026

2 Days Left Lead Plaintiff Deadline: October 05, 2026

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Additional Comments

Background

On October 20, 2025, Replimune 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 Company also claimed that “[d]uring the past few months, Replimune has been working to address agency feedback” and that “[a]dditional information, data and analyses were included in the resubmission which will be part of the BLA review.” The Company also stated that “[t]he FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.”

However, on April 10, 2026, during market trading, the FDA published a Complete Response Letter (“CRL”) rejecting Replimune’s BLA. 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 further 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.

In the CRL the FDA further revealed that 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, the Company’s share price fell $1.15 or 19.46%, before trading was halted, to close at $4.76 per share on April 10, 2026, on unusually heavy trading volume.

Then, on April 10, 2026, after the market closed, the Company issued a press release discussing the FDA’s response letter for the RP1 BLA. 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, the Company’s share price continued to fall $3.06 or 64.29%, to close at $1.70 per share on April 13, 2026, on unusually heavy trading volume.

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