#Class Action #FDA # #Replimune Group

Securities Class Action Alert: Replimune Group, Inc.

Investors of Replimune Group, Inc. (NASDAQ: REPL) are urged to take notice of an impending deadline regarding a securities class action that has been filed following allegations of misleading information provided to shareholders. The action pertains to investors who purchased shares between October 20, 2025, and April 10, 2026. The deadline for potential lead plaintiffs to apply is set for October 5, 2026.

Background Information

The crux of the lawsuit focuses on Replimune's statements regarding its RP1 resubmission, which the company asserted was a complete response to a deficiency letter received from the FDA. However, investors claim that the company failed to meet the necessary evidentiary standards for what constitutes an “adequate and well-controlled” clinical trial. This misrepresentation allegedly resulted in significant financial losses for investors, particularly following the sharp decline in stock prices subsequent to the FDA's Complete Response Letter.

On December 8, 2025, shares for Replimune reached a high of $10.73. However, following negative feedback from the FDA regarding the adequacy of their clinical trials, the share price plummeted by 19.46%, falling to $4.76, and further decreased to $1.70 within days. This stark reduction represents approximately an 84% decrease in value, resulting in a $9.03 loss per share for investors who had purchased during the specified class period.

Allegations in the Complaint

The complaint points out specific concerns regarding the trial’s design and the data provided in support of the RP1 application. According to the lawsuit:

• - The FDA indicated that the RPL-001-16 study