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Investing.com - JPMorgan downgraded Replimune Group (NASDAQ:REPL) stock rating from Neutral to Underweight and removed its previous $6 December 2026 price target. The downgrade adds pressure to REPL shares, which have already declined nearly 40% in the past week and 71% year-to-date, according to InvestingPro data.
The downgrade comes despite JPMorgan acknowledging that the overall data for Replimune’s RP1 treatment in refractory melanoma appears compelling and warrants approval.
Previous IGNYTE trial data showed RP1 in combination with nivolumab demonstrated approximately 33% objective response rate in refractory melanoma patients, with about 15% achieving complete responses.
The treatment showed responses in both injected and non-injected lesions across various sub-groups, with a median duration of response of 21.6 months and no major safety concerns identified.
Despite these positive clinical results and clear unmet need in the indication, JPMorgan cited uncertainty around the regulatory path forward for RP1 as the primary reason for the downgrade, noting that accelerated approval now "seems less likely." Get deeper insights into REPL’s financial health and 15+ additional ProTips with an InvestingPro subscription.
In other recent news, Replimune Group has been navigating significant challenges following developments with its melanoma treatment candidate, RP1. The company held a Type A meeting with the U.S. Food and Drug Administration (FDA) to address a complete response letter concerning their Biologics License Application for RP1 in combination with nivolumab. Despite these efforts, a clear path forward under the accelerated approval pathway has not been established. Additionally, reports indicate that the FDA’s top cancer drug regulator intervened late in the review process, leading to the treatment’s rejection, despite some internal support within the agency.
In response to these developments, H.C. Wainwright has maintained a Neutral rating on Replimune, while Jefferies adjusted its price target for the company from $10 to $8, though it maintained a Buy rating. Replimune has submitted a briefing book to the FDA addressing concerns raised in the complete response letter, focusing on patient population agreements and criteria for PD-1 resistance. These recent developments have significantly impacted the company’s stock and its strategy moving forward.
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