Replimune Group’s FDA Resubmission for RP1 Accepted

An update from Replimune Group ( (REPL) ) is now available.

On October 20, 2025, Replimune Group announced that the FDA accepted their resubmission of the Biologics License Application for RP1 in combination with nivolumab for advanced melanoma treatment. The FDA set a PDUFA date of April 10, 2026, marking a significant step in providing new treatment options for patients who have progressed on PD-1 based therapies. This acceptance follows Replimune’s efforts to address FDA feedback, and the resubmission is considered a complete response to a previous letter from the FDA.

The most recent analyst rating on (REPL) stock is a Buy with a $18.00 price target. To see the full list of analyst forecasts on Replimune Group stock, see the REPL Stock Forecast page.

Spark’s Take on REPL Stock

According to Spark, TipRanks’ AI Analyst, REPL is a Neutral.

Replimune Group’s stock score reflects its early-stage status in the biotechnology sector, characterized by significant R&D investments leading to negative earnings and cash flows. While the company shows strong equity, the current technical indicators suggest mixed to bearish market momentum. Valuation remains challenging due to negative earnings. The company’s future success hinges on the development and commercialization of its products.

To see Spark’s full report on REPL stock, click here.

More about Replimune Group

Replimune Group, Inc., founded in 2015 and headquartered in Woburn, MA, is a clinical-stage biotechnology company focused on developing novel oncolytic immunotherapies. Their proprietary RPx platform is designed to enhance immunogenic cell death and induce a systemic anti-tumor immune response, with the potential to be used alone or in combination with other cancer treatments.

Average Trading Volume: 10,062,649

Technical Sentiment Signal: Sell

Current Market Cap: $351.3M

Find detailed analytics on REPL stock on TipRanks’ Stock Analysis page.