Core Viewpoint - Replimune Group, Inc. is under investigation for possible securities fraud following a significant stock decline after the FDA's rejection of its Biologics License Application for RP1 [1][3][4] Group 1: Company Overview - Replimune Group, Inc. is a biotechnology company focused on developing treatments for advanced melanoma [3] - The company received a Complete Response Letter (CRL) from the FDA regarding its application for RP1 in combination with nivolumab [3][4] Group 2: Regulatory Developments - The FDA stated that the IGNYTE trial was not adequate for providing substantial evidence of effectiveness, leading to the rejection of the application [4] - The CRL was issued on July 22, 2025, prior to market open [3] Group 3: Market Reaction - Following the FDA announcement, Replimune's stock fell sharply by $9.52 per share, representing a decline of over 77%, closing at $2.80 on July 22, 2025 [4] Group 4: Legal Actions - The Portnoy Law Firm has initiated an investigation and may file a class action on behalf of investors who lost money due to the stock decline [1][2] - Investors are encouraged to contact the law firm for a complimentary case evaluation regarding their legal rights [2][5]
Replimune Group, Inc. Investors: Company Investigated by the Portnoy Law Firm