Replimune Group faces a securities class action after the FDA rejected its lead melanoma drug RP1. Shares plunged 64 percent following the April 10 Complete Response Letter. Investors have until Oct. 5, 2026 to file a lead plaintiff motion.
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Replimune investors sue after FDA rejection cuts stock 64%
Replimune Group Inc. faces a securities class action after its shares plunged 64 percent when the FDA rejected its lead melanoma drug application. The lawsuit, filed on behalf of investors who bought REPL securities between Oct. 20, 2025 and April 10, 2026, alleges the biotech misled shareholders about the viability of its lead candidate RP1 (vusolimogene oderparepvec).
The FDA said the evidence "does not meet the evidentiary standards required for regulatory approval," according to the Complete Response Letter published April 10. The agency found that "the study design concerns previously communicated were not addressed, and the contribution of RP1 to the observed response rate in RPL-001-16 could not be determined."
The complaint alleges Replimune failed to disclose that it had submitted data from an early unplanned analysis of the RP1-104 trial that included only 40 patients, 10 percent of the planned enrollment of 400. The company had announced Oct. 20, 2025 that the FDA accepted the resubmission of its Biologics License Application for RP1 in combination with nivolumab for advanced melanoma patients who progress on an anti-PD-1 regimen, calling the filing "a complete response to the complete response letter received in July 2025."
Shares fell $1.15, or 19.46 percent, to close at $4.76 on April 10 after the FDA published the rejection during market trading. The stock dropped another $3.06, or 64.29 percent, to $1.70 on April 13 after Replimune issued a press release conceding the FDA preferred a randomized controlled trial while claiming a single-arm study could be acceptable under accelerated approval if the data were compelling.
Investors have until Oct. 5, 2026 to file a lead plaintiff motion. Robbins LLP, Holzer & Holzer LLC, the Law Offices of Howard G. Smith and the Law Offices of Frank R. Cruz are among firms soliciting affected shareholders.
The rejection leaves Replimune without an approved product and its lead candidate in regulatory limbo, with the company needing to redesign its trials to satisfy FDA concerns. Investors will watch for any resubmission plan or partnership as the company weighs its next steps.
This article is for informational purposes only and does not constitute investment advice.
[1] REPL INVESTOR ALERT: Class Action Lawsuit Filed on Behalf of Replimune Group Investors – Holzer & Holzer, LLC Encourages Investors With Significant Losses to Contact the Firm[2] Stockholder Alert: Robbins LLP Informs Investors of the Replimune Group, Inc. Class Action[3] Law Offices of Howard G. Smith Encourages Replimune Group, Inc. (REPL) Shareholders to Inquire About Securities Fraud Class Action[4] Law Offices of Frank R. Cruz Encourages Replimune Group, Inc. (REPL) Shareholders To Inquire About Securities Fraud Class Action
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