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Replimune Faces Major Securities Class Action Post FDA Rejection

On July 31, 2025, a significant securities class action lawsuit was filed against Replimune Group, Inc. This lawsuit, termed Jboor v. Replimune Group, Inc., arises after a catastrophic decline in Replimune's stock value following the Food and Drug Administration's (FDA) rejection of its melanoma treatment, RP1. The class action targets investors who got involved with Replimune's securities between November 22, 2024, and July 21, 2025.

The challenges began on July 22, 2025, when Replimune disclosed that the FDA had issued a “complete response letter” regarding its application for RP1, indicating that the regulatory body was unable to approve the drug in its current format. Following this announcement, shares plummeted a staggering 77%, with unusually high trading volume suggesting panic among investors trying to mitigate their losses.

According to Hagens Berman, the national shareholder rights law firm leading the investigation, there are serious allegations that Replimune misled investors about their pivotal IGNYTE study, which was the cornerstone of their FDA application. The firm requests that any investors experiencing substantial losses contact them.

Within the period leading up to the FDA's announcement, Replimune had projected an optimistic view of RP1's prospects. They touted its Breakthrough Therapy designation and an Accelerated Approval pathway, claiming that approximately one-third of patients in the IGNYTE study could achieve a durable response.

However, the complaint asserted that Replimune not only overstated the IGNYTE trial's prospects but also failed to appropriately disclose significant concerns. The FDA found that the IGNYTE trial was poorly designed and inadequately controlled, leaving doubts about the drug's effectiveness. Furthermore, the variation in the patient demographics involved in the study raised significant questions about the trial's validity, making it challenging to draw any definitive conclusions about the treatment.

The FDA's conclusion was particularly damaging for Replimune, indicating that the company should revisit its trial designs and the presentation of its data. The explicit mention that the trial could not be confirmed as a competent proof of its efficacy presented a tremendous blow to the investor community.

With the market's rapid reaction sending the stock price crashing, Hagens Berman's principal partner in the investigation, Reed Kathrein, noted the firm's focus on whether Replimune misled investors regarding the IGNYTE trial's data and design.

Investors who have incurred significant losses following this downturn are being encouraged to participate in the class action. They are also seeking individuals with non-public information related to Replimune's operations to come forward, potentially benefiting from the SEC Whistleblower program.

In conclusion, the recent developments surrounding Replimune, particularly the legal implications following the FDA's rejection of RP1, mark a critical chapter for both the company and its investors. Stakeholders are advised to stay alert and act according to their financial interests in light of the ongoing investigations and potential legal outcomes surrounding this case.