Robbins LLP Urges REPL Investors Who Lost Money Investing in Replimune to Contact the Firm for Information About Leading the Class Action

Shareholder rights law firm Robbins LLP reminds investors that a class action was filed on behalf of all persons and entities that purchased or otherwise acquired Replimune Group, Inc. (NASDAQ: REPL) securities between October 20, 2025 and April 10, 2026 ('Class Period'). Replimune purports to be a clinical-stage biotechnology company focused on novel oncolytic immunotherapies. According to the complaint, the Company's lead product candidate is RP1 (vusolimogene oderparepvec). The lawsuit alleges that the Company misled investors regarding the efficacy and viability of its lead product candidate RP1. If you purchased or otherwise acquired REPL securities during the applicable Class Period and suffered a loss, you may have legal rights. Contact Robbins LLP for information about becoming lead plaintiff before the October 5, 2026 deadline.

On October 20, 2025, Replimune announced 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 claimed 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.' The complaint alleges that defendants failed to disclose to investors: (1) that in connection with the BLA, the study design concerns previously communicated by the FDA were not addressed; (2) that the Company had submitted data from an early unplanned analysis from RP1-104, which included only 40 patients (10% of the planned enrollment of 400 patients); (3) that, as a result, RPL-001-16 and RP1-104 both had deficiencies which were likely to cause the FDA to reject the BLA; and (4) that, as a result, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

The complaint alleges that on April 10, 2026, during market trading, the FDA published a Complete Response Letter ('CRL') rejecting Replimune's 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, 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. The complaint continues that 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 c...