Warning to Replimune shareholders: Class action lawsuit looms with a lead plaintiff deadline of September 22, 2025, as per Faruqi & Faruqi's announcement - REPL
Replimune Group Faces Securities Investigation and FDA Setback
In a recent development, Replimune Group, Inc. (NASDAQ: REPL) is under investigation for potential violations of federal securities laws, and the company has also faced a setback from the US Food and Drug Administration (FDA).
According to a complaint filed by Faruqi & Faruqi, LLP, Replimune and its executives are accused of overstating the prospects of the IGNYTE trial and failing to disclose material issues. The law firm is encouraging anyone with information regarding Replimune's conduct to contact them, including whistleblowers, former employees, shareholders, and others.
On July 22, 2025, Replimune received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for RP1. The FDA deemed the IGNYTE trial inadequate and not well-controlled, stating that it does not provide substantial evidence of effectiveness. The CRL indicates that the FDA is unable to approve the application in its present form.
The FDA's decision led to a significant drop in Replimune's common stock, decreasing over 73% during intraday trading on the same day.
Faruqi & Faruqi is reminding investors of the September 22, 2025 deadline to seek the role of lead plaintiff in a federal securities class action against Replimune. Any member of the putative class can move the Court to serve as lead plaintiff through counsel of their choice. The court-appointed lead plaintiff in the Replimune class action is the investor with the largest financial interest in the relief sought by the class.
Investors who purchased or acquired securities in Replimune between November 22, 2024 and July 21, 2025 can contact Faruqi & Faruqi partner Josh Wilson for legal advice. To learn more about the Replimune class action, visit www.faruqilaw.com/REPL or contact Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310).
Faruqi & Faruqi, LLP is a leading national securities law firm, and investors who wish to follow updates on the case can do so on LinkedIn, X, or Facebook. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
A photo accompanying this announcement is available at this link.
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