REPL Data Problems Trigger Investor Lawsuit

Replimune said everything was good to go with its FDA application for a cancer drug. The data looked great. The FDA was going to approve it. Everything was terrific. Only… none of that was true. After the FDA knocked back the drug application, the stock dropped an eye-popping 77%. Now, investors are suing.

In November 2024, Replimune announced its Biologics License Application for its cancer drug, R-P1. Executives bragged about its Breakthrough Therapy status and said the data was strong. They doubled down in February 2025, boasting again about great results - and that the FDA had accepted the application for priority review.

But here's what they didn't say: The FDA had raised major concerns about the study design and the reliability of the data.

Investors didn't find that out until July - when the FDA issued a rejection. The agency said the trial design was flawed and didn't prove R-P1 actually worked. Replimune's stock collapsed 77% in a single day.

Now, more shareholders are joining the lawsuit.