Kirby McInerney LLP Reminds Replimune Group, Inc. Investors of Class Action Filing and Encourages Investors to Contact the Firm
If you suffered a loss on your Replimune investments, you have until September 22, 2025 to request lead plaintiff appointment. Follow the link below for more information:
[CONTACT THE FIRM IF YOU SUFFERED A LOSS]
What Happened?
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.
What Is The Lawsuit About?
The lawsuit has been filed on behalf of investors who purchased securities during the period of November 22, 2024 through July 21, 2025, inclusive (“the Class Period”). The lawsuit alleges that 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.
[CLICK HERE TO LEARN MORE ABOUT THE CLASS ACTION]
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ContactsKirby McInerney LLPThomas W. Elrod, Esq.212-699-1180https://[email protected]