Replimune Faces Class Action Lawsuit After FDA Rejects Key Therapy
Investors who purchased Replimune Group securities face an October 5, 2026, deadline to seek appointment as lead plaintiff in a class action lawsuit. The litigation follows a sharp decline in the company’s stock price triggered by a regulatory rejection of its lead drug candidate, RP1, by the FDA.
The legal action centers on allegations of securities fraud and unlawful business practices by Replimune and its leadership. On April 10, 2026, the FDA issued a Complete Response Letter rejecting the company’s Biologics License Application for RP1 in combination with nivolumab. Regulators cited significant deficiencies in the IGNYTE and IGNYTE-3 studies, noting that the provided data failed to demonstrate substantial evidence of effectiveness. The FDA further stated that concerns regarding the study design—previously communicated to the company—remained unaddressed.
Following the news, Replimune’s share price dropped 19.46% on April 10, closing at $4.76. After the company released a statement attempting to address the regulatory feedback, shares fell an additional 64.29% by April 13, settling at $1.70. Investors seeking to join the class action are directed to contact Danielle Peyton at Pomerantz LLP.
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