Replimune ($REPL) FDA Rejection, Misleading Trial Claims, and RP1 Collapse Case

Court: D. Massachusetts

Case: 1:25-cv-12085

• REPL investors filed a claim against Replimune for overstating the strength of its lead therapy RP1, misrepresenting the viability of its Phase 2 IGNYTE trial, and concealing critical FDA concerns about study design and patient heterogeneity.
• After the FDA rejected its Biologics License Application for RP1, citing inadequate trial design, REPL crashed 77.24% on July 22, 2025.
• REPL investors can join this case to be notified about potential recovery.

Case Details:

Between November 22, 2024, and July 21, 2025, Replimune told investors that RP1—a combination therapy with nivolumab—was positioned for accelerated FDA approval for anti-PD1 failed melanoma. The company repeatedly cited its Breakthrough Therapy Designation, enrollment progress, and IGNYTE trial results to build investor confidence, portraying the study as “registration-directed.”

Internally, however, Replimune knew that the IGNYTE trial lacked the controls, population uniformity, and statistical power required for regulatory approval. Executives continued to promote the upcoming PDUFA date without warning investors of the trial’s shortcomings.

On July 22, 2025, the FDA issued a Complete Response Letter rejecting the RP1 application, citing failure to demonstrate adequate and well-controlled evidence of efficacy due to excessive patient heterogeneity. REPL collapsed 77.24% to close at $2.80.

Based on these events, REPL investors filed a claim against Replimune, alleging the company:

• It misled investors about the likelihood of RP1’s FDA approval.
• It concealed key flaws in trial design and regulatory readiness.
• It maintained an inflated growth narrative despite internal warnings.

Investors argue Replimune overstated RP1’s prospects to preserve its valuation and secure continued capital.