A securities class action has been filed against Replimune Group, Inc. (REPL) on behalf of persons or entities who purchased or otherwise acquired publicly traded Replimune securities between November 22, 2024 through July 21, 2025. This case has been filed in the USDC – MA.
On July 22, 2025, Replimune announced that it received a Complete Response Letter from the FDA rejecting its Biologics License Application for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. In the CRL, the FDA indicated that “the IGNYTE trial is not considered to be an adequate and well-controlled clinical investigation that provides substantial evidence of effectiveness.” Following this news, REPL’s stock price fell over 78% to open at $2.70 per share on July 22, 2025.
The complaint alleges that Defendants made false and misleading statements regarding the prospects of a clinical trial and the related biologics license application to the FDA. Plaintiff claims Defendants knew or recklessly disregarded that the trial was inadequate and not well-controlled, leading to the FDA’s refusal to approve the application. Plaintiff alleges these actions resulted in artificially inflated stock prices during the class period.