Replimune(US:REPL) Yahoo Finance·2025-10-20 20:10Core Viewpoint - Replimune Group's stock experienced significant volatility, more than doubling in value due to positive regulatory news regarding its investigational drug RP1 for advanced melanoma [1][2]. Regulatory Developments - The U.S. Food and Drug Administration (FDA) accepted the resubmission of Replimune's Biologics License Application (BLA) for RP1, which targets advanced melanoma in combination with Bristol Myers Squibb's Opdivo [2]. - The FDA has set a decision deadline for the drug's approval on April 10, 2026 [3]. - The acceptance of the BLA erased previous concerns stemming from a complete response letter issued by the FDA in June, which indicated that the initial application would not be approved as submitted [3][4]. Market Reaction - Following the FDA's acceptance, there was a strong resurgence in investor interest, leading to a significant increase in Replimune's stock price, which outperformed the S&P 500 index [1][4].