Replimune Group, Inc.

Case Overview
40 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 09/22/2025 |
Status: | Status: Investigating |
Company Name: | Company Name: Replimune Group, Inc. |
Court: | Court: District of Massachusetts |
Case Number: | Case Number: 1:25cv12085 |
Class Period: | Class Period: 11/22/2024 - 07/21/2025 |
Ticker: | Ticker: REPL |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of Massachusetts on behalf of those who acquired Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ:REPL) securities during the period of November 22, 2024 through July 21, 2025, inclusive (“the Class Period”). Investors have until September 22, 2025 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
On July 22, 2025, Replimune announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for its lead product RP1, in combination with immunotherapy drug nivolumab, for the treatment of advanced melanoma. In the CRL, the FDA indicated Replimune’s IGNYTE trial is “not considered to be an adequate and well-controlled clinical investigation that provides sub-stantial evidence of effectiveness.” On this news, the price of Replimune shares declined by $9.52 per share, or approximately 77.24%, to close at $2.81 per share on July 22, 2025.
According to the lawsuit, Replimune made false and/or misleading statements and/or failed to disclose that the Company overstated the IGNYTE trial’s prospects, which resulted in the FDA deeming the IGNYTE trial inadequate and not well-controlled.
On July 22, 2025, Replimune announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for its lead product RP1, in combination with immunotherapy drug nivolumab, for the treatment of advanced melanoma. In the CRL, the FDA indicated Replimune’s IGNYTE trial is “not considered to be an adequate and well-controlled clinical investigation that provides sub-stantial evidence of effectiveness.” On this news, the price of Replimune shares declined by $9.52 per share, or approximately 77.24%, to close at $2.81 per share on July 22, 2025.
According to the lawsuit, Replimune made false and/or misleading statements and/or failed to disclose that the Company overstated the IGNYTE trial’s prospects, which resulted in the FDA deeming the IGNYTE trial inadequate and not well-controlled.