Replimune Class Action Lawsuit Filed Over Misleading Cancer Drug Claims.

A securities class action lawsuit has been filed against Replimune Group, alleging that the company misled investors by overstating the success of its lead cancer drug, RP1. The lawsuit follows the FDA's rejection of the drug application, which led to a 77% stock price crash. Investors who bought Replimune securities between November 22, 2024, and July 21, 2025, may be eligible to participate in the lawsuit. The lead plaintiff deadline is September 22, 2025.

A securities class action lawsuit has been filed against Replimune Group, Inc. (NASDAQ: REPL), alleging that the company misled investors by overstating the success of its lead cancer drug, RP1. The lawsuit follows the U.S. Food and Drug Administration (FDA) rejection of the drug's application, which led to a 77% stock price crash. Investors who purchased Replimune securities between November 22, 2024, and July 21, 2025, may be eligible to participate in the lawsuit. The lead plaintiff deadline is September 22, 2025 [1].

On July 22, 2025, Replimune publicly announced that the FDA had issued a "Complete Response Letter" (CRL) for its Biologics License Application (BLA) for RP1, effectively rejecting the drug's approval for advanced melanoma. The news triggered a massive sell-off, causing the company's stock to plummet by 77% in a single day, wiping out billions in market value [1].

The lawsuit, Jboor v. Replimune Group, Inc., alleges that Replimune presented a misleadingly optimistic view of its drug's prospects. The complaint points to the FDA's CRL as evidence, stating that the IGNYTE trial was not "a sufficiently well-designed or controlled investigation" to provide substantial evidence of effectiveness [1].

The complaint further alleges that Replimune failed to disclose that the company had overstated the likelihood of success for the IGNYTE trial and that the FDA was likely to find the trial's design and data inadequate for approval. Additionally, the trial had fundamental flaws, including a heterogeneous patient population, which made it difficult for the FDA to interpret the results [1].

Hagens Berman, a national plaintiffs' rights law firm, is actively investigating whether Replimune misled its investors. The firm is urging Replimune investors who suffered substantial losses to contact them now [1].

Investors who believe they may have been misled by Replimune are encouraged to submit their losses and any relevant information to Hagens Berman. The firm has secured more than $2.9 billion in investor fraud cases and represents investors, whistleblowers, and others harmed by corporate negligence [1].

References:
[1] https://www.prnewswire.com/news-releases/investor-lawsuit-targets-replimune-repl-after-fda-deems-rp1-trial-inadequate---hagens-berman-302546187.html
[2] https://www.morningstar.com/news/globe-newswire/9521675/replimune-repl-faces-investor-lawsuit-following-77-stock-crash-after-fda-rejects-key-drug-hagens-berman