Replimune Group, Inc.
Securities Class Action

On April 10, 2026, the FDA published a Complete Response Letter (“CRL”) rejecting Replimune’s Biologics License Application (“BLA”) for RP1 in combination with nivolumab. 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, Replimune’s stock price fell $1.15 per share, or 19.46%, to close at $4.76 per share on April 10, 2026. 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 per share, or 64.29%, to close at $1.70 per share on April 13, 2026.