Investors File Class Action Lawsuit Against Replimune Group
A class action lawsuit has been launched against biotechnology firm Replimune Group, Inc. following a sharp decline in share value. The litigation, filed by Robbins LLP, accuses the company of misleading investors regarding the clinical efficacy and regulatory viability of its lead immunotherapy candidate, RP1.
The legal action centers on the period between October 20, 2025, and April 10, 2026. According to the complaint, Replimune failed to address specific FDA concerns regarding study design for its RP1 treatment, which is intended for advanced melanoma. The lawsuit alleges the company relied on limited, early data from a 40-patient analysis—merely 10% of the intended enrollment—to support its Biologics License Application.
On April 10, 2026, the FDA issued a Complete Response Letter rejecting the application, citing deficiencies in both the RPL-001-16 and RP1-104 studies. The agency noted that it had previously communicated these design concerns to the company, yet they remained unresolved. Following the disclosure, Replimune’s stock price plummeted 19.46% during intraday trading. After the company released further details regarding the rejection, shares fell an additional 64.29% by April 13, 2026, closing at $1.70.
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