Replimune Investors Face October Deadline in Securities Class Action

The lawsuit claims Replimune failed to address critical FDA concerns regarding its study designs for RP1, which is intended for advanced melanoma patients. According to the complaint, the company submitted data from an early, unplanned analysis of only 40 patients—a small fraction of the 400-patient target—without disclosing that the FDA had previously flagged these methodological deficiencies. When the FDA issued a Complete Response Letter on April 10, 2026, rejecting the Biologics License Application, it noted that the company had ignored repeated warnings about the clinical investigation's adequacy.

Following the disclosure, Replimune’s stock price suffered a sharp decline. Shares fell nearly 20% on the day of the announcement and plummeted an additional 64% by April 13, 2026, as the market reacted to the company's admission that its trial design did not meet regulatory standards. Shareholders seeking to serve as lead plaintiff in the class action must file their applications by October 5, 2026. Participation in the litigation carries no upfront costs, as the law firm operates on a contingency fee basis.