The legal action, filed by Pomerantz LLP, centers on allegations of securities fraud and unlawful business practices by the company and its leadership. The dispute stems from an April 10, 2026, Complete Response Letter issued by the FDA, which denied the Biologics License Application for the drug RP1. Regulators cited significant deficiencies in two key studies, IGNYTE and IGNYTE-3, noting that the evidence provided failed to meet regulatory standards for effectiveness.

Internal correspondence revealed by the FDA indicated that the agency had previously communicated concerns regarding the company’s study design, which Replimune allegedly failed to address. Following the initial disclosure of the rejection, the company’s stock price plummeted 19.46%. The sell-off intensified after the company acknowledged that the FDA had preferred a randomized controlled trial, resulting in an additional 64.29% drop in share value by April 13, 2026. Investors seeking to participate in the class action are directed to contact Danielle Peyton at Pomerantz LLP to provide documentation of their holdings.