The litigation, filed in the U.S. District Court for the District of Massachusetts, centers on claims that Replimune executives withheld critical regulatory feedback. According to the complaint, the company characterized its resubmission to the FDA as a complete response to prior deficiencies, despite failing to address fundamental concerns regarding study design. The FDA’s subsequent Complete Response Letter explicitly stated that the RPL-001-16 trial was not considered an adequate or well-controlled investigation.

Shareholders experienced significant financial losses as these regulatory gaps surfaced. After peaking at $10.73 in December 2025, Replimune shares plummeted following the April 2026 FDA rejection. The stock fell 19.46% on April 10 and dropped an additional 64.29% by April 13, resulting in a cumulative decline of roughly 84%. Attorney Joseph E. Levi, representing the plaintiffs, contends that generic risk disclosures provided by the company were insufficient to cover the specific, known objections raised by federal regulators throughout the process.