Replimune Group, Inc.

Case Overview
Status: | Status: Investigating |
Company Name: | Company Name: Replimune Group, Inc. |
Ticker: | Ticker: REPL |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
The law firm of Kirby McInerney LLP is investigating potential claims against Replimune Group, Inc. (“Replimune” or the “Company”) (NASDAQ:REPL). The investigation concerns whether Replimune and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices.
On July 22, 2025, Replimune disclosed that 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 substantial 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.
On July 22, 2025, Replimune disclosed that 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 substantial 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.