Replimune (REPL) Shares Plummet After FDA Rejects Melanoma Drug, Sparking Investor Concerns - Hagens Berman
SAN FRANCISCO, July 23, 2025 (GLOBE NEWSWIRE) -- Investors in Replimune Group, a biotechnology company focused on cancer treatments, witnessed a dramatic collapse in their holdings on July 22. Shares plummeted by $9.52, a staggering 77% one-day drop, after the company announced that the Food and Drug Administration (FDA) had rejected its application for RP1, a new drug intended to treat advanced melanoma when used with nivolumab. The news, which arrived via a "complete response letter" — the FDA's formal way of saying "no" for now — triggered unusually high trading volume as investors rushed to sell.
Replimune’s revelation has prompted national shareholders rights firm Hagens Berman to open an investigation into whether Replimune may have misled investors about the IGNYTE study- the main study supporting Replimune's application. The firm urges Replimune investors who suffered substantial losses to submit your losses now. The firm also encourages persons with knowledge who may be able to assist in the investigation to contact its attorneys.
Visit: www.hbsslaw.com/investor-fraud/repl
Contact the Firm Now: REPL@hbsslaw.com
844-916-0895
Replimune Group, Inc. (REPL) Investigation:
The firm’s investigation is focused on the propriety of Replimune’s statements concerning data submitted to the FDA in support of its Biologics License Application (BLA).
Just recently, Replimune had painted an optimistic picture for its experimental drug, assuring the market that "data from the IGNYTE study shows that roughly one-third of patients are able to achieve durable response in a high unmet need setting with few options." This assertion fueled hopes that RP1 could offer a crucial new treatment for a particularly aggressive form of skin cancer.
However, that optimism was severely dashed by its July 22nd announcement. Replimune revealed that the FDA's letter made it clear that the agency was "unable to approve the application in its present form." More critically, the FDA stated that the IGNYTE trial was not considered a sufficiently well-designed or controlled investigation to provide solid proof of the drug's effectiveness. This suggests fundamental issues with how the trial was conducted.
Furthermore, the FDA found that the trial's results could not be properly understood because of the wide variation in the patient population included in the study. Essentially, the patients in the trial were too different from each other, making it difficult to draw reliable conclusions about the drug's impact. The agency also pointed out problems with the design of the necessary confirmatory trial, including questions about how each component of the treatment contributed to the overall effect.
The market reacted swiftly, sending the price of Replimune shares crashing 77% lower on unusually high volume on July 22, 2025.
“We’re investigating whether Replimune may have misled investors about its IGNYTE trial design and data,” said Reed Kathrein, the Hagens Berman partner leading the investigation.
If you invested in Replimune and have substantial losses, or have knowledge that may assist the firm’s investigation, submit your losses now »
Whistleblowers: Persons with non-public information regarding Replimune should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at 844-916-0895 or email REPL@hbsslaw.com.
Hagens Berman is a global plaintiffs’ rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman’s team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.
Contact:
Reed Kathrein, 844-916-0895
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