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Replimune Group Plunges 77.36% After FDA Rejects RP1
Generated by AI AgentAinvest Pre-Market Radar
Tuesday, Jul 22, 2025 7:58 am ET1min read
Aime SummaryOn July 22, 2025,
Group's stock experienced a significant drop of 77.36% in pre-market trading.Replimune Group's stock is under intense scrutiny following the FDA's rejection of its lead drug, RP1, which was part of a combination regimen for melanoma, a type of skin cancer. The FDA issued a complete response letter, indicating that the clinical trial data provided by Replimune was not sufficient to demonstrate the drug's effectiveness. The agency cited issues with the trial's design and the heterogeneity of the patient population as reasons for the rejection.
Replimune has stated that it will request a meeting with the FDA to discuss a path forward for the approval of RP1. The company has previously indicated that it has a full commercial infrastructure in place for a potential product launch. Despite the setback, Replimune has not raised any safety concerns related to RP1.
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